Roche Diagnostics Operations, Inc.

United States of America

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G01N 35/00 - Automatic analysis not limited to methods or materials provided for in any single one of groups Handling materials therefor 289
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1.

A TRANSIMPEDANCE AMPLIFIER CIRCUIT

      
Application Number EP2024088030
Publication Number 2025/133212
Status In Force
Filing Date 2024-12-20
Publication Date 2025-06-26
Owner
  • ROCHE DIAGNOSTICS GMBH (Germany)
  • F. HOFFMANN-LA ROCHE AG (Switzerland)
  • ROCHE DIAGNOSTICS OPERATIONS, INC. (USA)
Inventor
  • Goerzen, Markus
  • Lambertson, Michael

Abstract

A transimpedance amplifier circuit (110) is proposed, comprising at least one transimpedance amplifier (112). The transimpedance amplifier comprises at least one variable feedback resistor (114) and at least one operational amplifier (116). The variable feedback resistor (114) is connected between an input of an operational amplifier (116) and an output of the operational amplifier (116).

IPC Classes  ?

  • H03F 3/45 - Differential amplifiers
  • H03G 1/00 - Details of arrangements for controlling amplification
  • H03G 3/30 - Automatic control in amplifiers having semiconductor devices

2.

QUALITATIVE TEST FOR DIRECT ORAL ANTICOAGULANTS (DOACS)

      
Application Number EP2024087250
Publication Number 2025/132678
Status In Force
Filing Date 2024-12-18
Publication Date 2025-06-26
Owner
  • F. HOFFMANN-LA ROCHE AG (Switzerland)
  • ROCHE DIAGNOSTICS GMBH (Germany)
  • ROCHE DIAGNOSTICS OPERATIONS, INC. (USA)
Inventor Meyer Dos Santos, Sascha

Abstract

The present invention concerns the field of point-of-care diagnostics. In particular, it relates to a method for determining an anticoagulant in a blood sample. The method comprises the following steps: a) providing a composition comprising: i) thrombin or a prothrombin activator converting prothrombin into thrombin that is factor Xa (FXa) inhibitor insensitive, or mixtures thereof; and ii) FXa or a prothrombin activator converting prothrombin into thrombin that is FXa inhibitor sensitive, or mixtures thereof; b) contacting a blood sample with the composition thereby generating a mixture of the composition with the blood sample, wherein the mixture comprises at least 0.01 nkat of thrombin activity and at least 0.05 nkat of FXa activity; c) measuring thrombin activity using a substrate capable of detecting thrombin activity; d) comparing the measured thrombin activity to a reference; and e) determining the anticoagulant based on the comparison. Moreover, the invention contemplates a kit for carrying out such methods, working electrodes of an analyte sensor capable of detecting thrombin activity and analyte sensors comprising the same, as well as a devices for determining an anticoagulant in a blood sample.

IPC Classes  ?

  • C12Q 1/56 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving blood clotting factors, e.g. involving thrombin, thromboplastin, fibrinogen
  • G01N 33/86 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing involving blood coagulating time

3.

MODULAR QUALITY MANAGEMENT SYSTEMS AND METHODS

      
Application Number US2024060073
Publication Number 2025/136818
Status In Force
Filing Date 2024-12-13
Publication Date 2025-06-26
Owner
  • ROCHE MOLECULAR SYSTEMS, INC. (USA)
  • ROCHE SEQUENCING SOLUTIONS, INC. (USA)
  • ROCHE DIAGNOSTICS OPERATIONS, INC. (USA)
  • ROCHE DIAGNOSTICS INTERNATIONAL AG (Switzerland)
  • ROCHE DIAGNOSTICS GMBH (Germany)
  • VENTANA MEDICAL SYSTEMS, INC. (USA)
Inventor
  • Arya, Meetu
  • Blair, Timothy Patrick
  • Burek, Devon Margaux
  • Clark, Adam Robert
  • Nebl, Gabriele
  • Nelson, Amy Marie
  • Parris, Kareena
  • Pilz, Matthias

Abstract

A system for quality control of a medical device or software product including a plurality of quality control (QC) modules, each QC module configured for one or more QC task(s) of a QC process and configured for access by a plurality of users assigned roles and responsibilities for the respective QC task(s), the quality control library configured to store a plurality of QC records including information associated with the QC task(s) and governmental rule(s) or regulation(s) applicable to the respective QC module and medical device product.

IPC Classes  ?

  • G16H 40/20 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms
  • G06Q 10/0639 - Performance analysis of employeesPerformance analysis of enterprise or organisation operations
  • G06Q 30/018 - Certifying business or products

4.

TECHNIQUES FOR ILLUMINATION AND DETECTION IN ANALYTICAL ANALYZERS

      
Application Number EP2024086338
Publication Number 2025/132105
Status In Force
Filing Date 2024-12-13
Publication Date 2025-06-26
Owner
  • F. HOFFMANN-LA ROCHE AG (Switzerland)
  • ROCHE DIAGNOSTICS GMBH (Germany)
  • ROCHE DIAGNOSTICS OPERATIONS, INC. (USA)
Inventor Wietzorrek, Joachim

Abstract

In one general aspect, the present disclosure relates to an analytical analyzer (100) including a sample support (107) defining a sample area, an illumination assembly (109) configured to illuminate the sample area with illumination light (9), a matrix detector (6) and a detection assembly (111) configured to image light (7) emitted from the sample area onto the matrix detector (6). The analytical analyzer (100) further includes a field lens array including a plurality of field lens elements (202) arranged over the sample area so that the illumination light (9) and the light (7) emitted from the sample traverses through the field lens array (18) and an opaque grid (103) arranged to cover the edges of each of the plurality of field lens elements (202).

IPC Classes  ?

5.

ANTIBODY AGAINST SKELETAL TROPONIN T AND DIAGNOSTIC USES THEREOF

      
Application Number EP2024087843
Publication Number 2025/133083
Status In Force
Filing Date 2024-12-20
Publication Date 2025-06-26
Owner
  • F. HOFFMANN-LA ROCHE AG (Switzerland)
  • ROCHE DIAGNOSTICS GMBH (Germany)
  • ROCHE DIAGNOSTICS OPERATIONS, INC. (USA)
Inventor
  • Alhusseini, Mohamad Ali
  • Boehm, Kati
  • Gerg, Michael
  • Hillringhaus, Lars
  • Jucknischke, Ute
  • Knoll, Marko
  • Kunzelmann, Stefan
  • Roesser, Alisa
  • Stiegler, Sandrine Carolina

Abstract

The present invention refers, inter alia, to an antibody against skeletal Troponin T (skTnT), wherein the anti-skTnT antibody is not capable of binding to cardiac Troponin T (cTnT). The present invention also relates to uses of said antibodies for determining a skeletal muscle damage, methods of determining the amount of skTnT, wherein the method comprises contacting a sample with at least one of said antibodies, and determining the amount of skTnT. The invention further refers to corresponding polynucleotides encoding for and compositions comprising said antibody. The invention also relates to a computer-implemented method of determining an amount of skTnT using said antibody.

IPC Classes  ?

  • C07K 16/18 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans
  • G01N 33/68 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing involving proteins, peptides or amino acids

6.

CARDIAC TROPONIN T QUANTIFICATION

      
Application Number EP2024087793
Publication Number 2025/133043
Status In Force
Filing Date 2024-12-20
Publication Date 2025-06-26
Owner
  • F. HOFFMANN-LA ROCHE AG (Switzerland)
  • ROCHE DIAGNOSTICS GMBH (Germany)
  • ROCHE DIAGNOSTICS OPERATIONS, INC. (USA)
Inventor
  • Alhusseini, Mohamad Ali
  • Boehm, Kati
  • Gerg, Michael
  • Hillringhaus, Lars
  • Jucknischke, Ute
  • Knoll, Marko
  • Kunzelmann, Stefan
  • Roesser, Alisa
  • Stiegler, Sandrine Carolina

Abstract

The present invention refers, inter alia, to a method of determining the amount of cardiac Troponin T (cTnT) in a sample, said method comprising a) contacting the sample with an anti-cTnT antibody and with an antibody against skeletal Troponin T (anti-skTnT antibody), wherein the anti-cTnT antibody is capable of binding to a cTnT peptide sequence conserved between cTnT and skTnT, wherein the anti-skTnT antibody is not capable of binding to said conserved cTnT peptide sequence, and wherein the anti-skTnT antibody is capable of binding to a skTnT peptide sequence conserved between skTnT and cTnT, thereby preventing binding of the anti-cTnT antibody to skTnT, and b) determining the amount of cTnT; as well as to uses of said antibodies for determining the amount of cTnT, for preventing skTnT interference in determining the amount of cTnT, and/or for maintaining and/or improving specificity and diagnostic accuracy for a disease associated with cTnT.

IPC Classes  ?

  • G01N 33/68 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing involving proteins, peptides or amino acids

7.

METHOD AND SYSTEM FOR APPLYING A LIQUID SAMPLE ONTO A SUBSTRATE FOR IMAGE ANALYSIS

      
Application Number EP2024085313
Publication Number 2025/131829
Status In Force
Filing Date 2024-12-09
Publication Date 2025-06-26
Owner
  • F. HOFFMANN-LA ROCHE AG (Switzerland)
  • ROCHE DIAGNOSTICS GMBH (Germany)
  • ROCHE DIAGNOSTICS OPERATIONS, INC. (USA)
  • ROCHE DIAGNOSTICS HEMATOLOGY, INC. (USA)
Inventor
  • Conroy, Stephen Edward
  • Zahniser, David J
  • Harbers, Rik
  • Karagiannidis, Symeon
  • Kimmig, Anita
  • Poblet Casanovas, Nuria
  • Ruhl, Jaclyn

Abstract

The present disclosure relates to an automated method for applying a liquid sample (1) onto a substrate (2) for image analysis as well as an automated system (100) for performing the automated method. The automated method comprises providing data corresponding to a property of the liquid sample (1) from a property determination unit (20) to a workflow management unit (90); selecting, by the workflow management unit (90), sample preparation operations based on the property of the liquid sample (1); setting, by the workflow management unit (90), operational parameters based on the selected sample preparation operations and/or on the property of the liquid sample (1); controlling a sample preparation unit (10) to prepare the liquid sample (1) for image analysis by performing the sample preparation operations selected by the workflow management unit (90) and by using the operational parameters set by the workflow management unit (90).

IPC Classes  ?

  • G01N 1/28 - Preparing specimens for investigation
  • G01N 1/30 - StainingImpregnating
  • G01N 33/48 - Biological material, e.g. blood, urineHaemocytometers
  • G01N 35/10 - Devices for transferring samples to, in, or from, the analysis apparatus, e.g. suction devices, injection devices
  • G01N 1/00 - SamplingPreparing specimens for investigation
  • G01N 1/31 - Apparatus therefor
  • G01N 1/38 - Diluting, dispersing or mixing samples
  • G01N 1/40 - Concentrating samples

8.

CALIBRATION MANAGEMENT OF AN IN-VITRO DIAGNOSTIC SYSTEM

      
Application Number 18988760
Status Pending
Filing Date 2024-12-19
First Publication Date 2025-06-19
Owner Roche Diagnostics Operations, Inc. (USA)
Inventor
  • Bruckner, Richard
  • Eicher, Andreas
  • Gan, Li
  • Schwesig-Stelzer, Franz Korbinian

Abstract

A computer-implemented method of automatically managing calibration of an in-vitro diagnostic (IVD) system comprising executing calibration cycles/procedures comprising using calibration solutions, using a calibration solution comprising a first step of transporting the calibration solution to a measurement unit and a second step of measuring the calibration solution by the measurement unit. For each calibration cycle the method comprises starting repetition of the calibration procedure at the earliest at a start of a buffer time period before expiry of a respective calibration validity period, interrupting the calibration procedure upon receiving an order to execute a sample IVD test and restarting or resuming the calibration procedure after executing the sample IVD test, as long as repetition of the calibration procedure can be restarted or resumed within the buffer time period. Interrupting the calibration procedure comprises different steps depending on whether the order to execute a sample IVD test is received during using a first calibration solution or a subsequent calibration solution in a series of calibration solutions and whether it is received during the first step of transporting the first or a subsequent calibration solution to the measurement unit or the second step of measuring the first or a subsequent calibration solution. An IVD system performing operations associated with the method of automatically managing calibration is also disclosed.

IPC Classes  ?

  • G01N 35/00 - Automatic analysis not limited to methods or materials provided for in any single one of groups Handling materials therefor
  • G01N 35/10 - Devices for transferring samples to, in, or from, the analysis apparatus, e.g. suction devices, injection devices

9.

CHIMERIC IGG-FC-BINDING LIGAND POLYPEPTIDE AND USES THEREOF FOR IGG AFFINITY PURIFICATION

      
Application Number 18433619
Status Pending
Filing Date 2024-02-06
First Publication Date 2025-06-19
Owner Roche Diagnostics Operations, Inc. (USA)
Inventor
  • Eisenhauer, Romina
  • Kroner, Frank
  • Patel, Jigar
  • Schraeml, Michael
  • Strauss, Martin
  • Taeuber, Simone

Abstract

The present invention relates to a chimeric IgG-Fc-binding ligand polypeptide, comprising a protein fragment of SlyD, wherein the IF domain thereof is replaced by the affinity peptide Fc-III-4C or an Fc-III-XC variant thereof, as well as related uses for IgG affinity purification.

IPC Classes  ?

  • C07K 14/195 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from bacteria
  • C07K 1/22 - Affinity chromatography or related techniques based upon selective absorption processes
  • C12N 1/20 - BacteriaCulture media therefor

10.

TRANSDERMAL MEDICAL DEVICE AND KIT COMPRISING THE SAME

      
Application Number EP2024086309
Publication Number 2025/125608
Status In Force
Filing Date 2024-12-13
Publication Date 2025-06-19
Owner
  • ROCHE DIAGNOSTICS GMBH (Germany)
  • F. HOFFMANN-LA ROCHE AG (Switzerland)
  • ROCHE DIAGNOSTICS OPERATIONS, INC. (USA)
Inventor
  • Baer, Ute
  • Gottselig, Alina
  • Grupp, Florian
  • Zahn, Hans

Abstract

A transdermal medical device (110) is proposed, specifically for sampling of capillary blood, comprising at least one stationary component (118) and at least one movable component (120). The movable component (120) is mounted to the stationary component (118) in a movable manner. The movable component (120) is movable from a distal position (154) to a proximal position (156). The movable component (120) comprises at least one penetration element (140) configured for penetrating the skin of a user. The penetration element (140), in the distal position (154) of the movable component (120), is received within the stationary component (118). In the proximal position (156) of the movable component (120), the penetration element (140) protrudes from an application side (168) of the stationary component (118). The movable component (120) further comprises at least one magnetic driver element (138) which is configured such that a movement of the movable component (120) is drivable by at least one external magnetic force. Further, a body mount (112) for attaching the transdermal medical device (110) to a body surface of a user, a transdermal medical kit (114) comprising the transdermal medical device (110) and the body mount (112), and a method of driving a penetration element (140) are proposed.

IPC Classes  ?

  • A61B 5/15 - Devices for taking samples of blood
  • A61B 5/151 - Devices for taking samples of blood specially adapted for taking samples of capillary blood, e.g. by lancets
  • A61M 5/158 - Needles

11.

HEMOGLOBIN DETERMINATION METHODS AND SYSTEMS

      
Application Number EP2024084508
Publication Number 2025/119902
Status In Force
Filing Date 2024-12-03
Publication Date 2025-06-12
Owner
  • F. HOFFMANN-LA ROCHE AG (Switzerland)
  • ROCHE DIAGNOSTICS GMBH (Germany)
  • ROCHE DIAGNOSTICS OPERATIONS, INC. (USA)
Inventor Rieder, Roman

Abstract

The present invention relates to a method for determining hemoglobin in a sample comprising red blood cells, said method comprising (a) dispensing a first aliquot of said sample on a first working area of a substrate; (b) providing a hemolyzed second aliquot of said sample and dispensing said second aliquot on a second working area; and (c) determining the hemoglobin in said first and second working area, wherein said method comprises a further step of contacting said first working area, but not the second working area, with a treatment solution. The present invention also relates to systems and diagnostic methods related to said method.

IPC Classes  ?

  • G01N 33/72 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing involving blood pigments, e.g. hemoglobin, bilirubin
  • G01N 1/30 - StainingImpregnating
  • G01N 33/49 - Physical analysis of biological material of liquid biological material blood

12.

METHOD AND DEVICES FOR DETECTING A FIBRINOGEN LEVEL IN A SAMPLE

      
Application Number EP2024084819
Publication Number 2025/120038
Status In Force
Filing Date 2024-12-05
Publication Date 2025-06-12
Owner
  • ROCHE DIAGNOSTICS GMBH (Germany)
  • F. HOFFMANN-LA ROCHE AG (Switzerland)
  • ROCHE DIAGNOSTICS OPERATIONS, INC. (USA)
Inventor
  • Bauer-Espindola, Klaus Andreas
  • Lambertson, Michael
  • Meyer Dos Santos, Sascha
  • Schumacher, Dagmar

Abstract

A test element (110) for detecting a fibrinogen level in a sample (112) of a bodily fluid is disclosed. The test element (110) comprises at least one substrate (114) and at least one capillary (116) for receiving and transporting the sample (112). The test element (110) further comprises at least one test region (118) and at least one control region (120) within the capillary (116), wherein the test element (110), in the test region (118), comprises at least two test electrodes (122), wherein the test element (110), in the control region (120), comprises at least two control electrodes (124). The test element (110) further comprises, in the test region (118), at least one detector compound (126), the detector compound (126) being capable of specifically cleaving fibrinogen.

IPC Classes  ?

  • G01N 33/49 - Physical analysis of biological material of liquid biological material blood
  • C12Q 1/56 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving blood clotting factors, e.g. involving thrombin, thromboplastin, fibrinogen
  • G01N 33/86 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing involving blood coagulating time

13.

MEANS AND METHODS FOR DETERMINING FIBRINOGEN USING AN ASSAY BASED ON A COMPETITIVE MECHANISM

      
Application Number EP2024084115
Publication Number 2025/114544
Status In Force
Filing Date 2024-11-29
Publication Date 2025-06-05
Owner
  • F. HOFFMANN-LA ROCHE AG (Switzerland)
  • ROCHE DIAGNOSTICS GMBH (Germany)
  • ROCHE DIAGNOSTICS OPERATIONS, INC. (USA)
Inventor
  • Horn, Carina
  • Meyer Dos Santos, Sascha
  • Schumacher, Dagmar

Abstract

The present invention concerns the field of point-of-care diagnostics. In particular, it relates to a method for determining fibrinogen in a sample comprising the steps of (a) contacting a fibrinogen binding agent, said fibrinogen binding agent comprising a first molecule which is capable of specifically binding fibrinogen and, reversibly bound to the said first molecule, a second molecule which is capable of specifically binding the first molecule, wherein the affinity of said second molecule for the first molecule is lower than the affinity of fibrinogen for said first molecule, with a sample suspected to comprise fibrinogen for a time and under conditions which allow for specific binding of fibrinogen to said first molecule, whereby the second molecule is released from said first molecule and fibrinogen is specifically bound by the first molecule, (b) determining said second molecule released from said first molecule, and (c) determining fibrinogen in the sample based on the released second molecule. The invention further contemplates a method for assessing coagulation defects or disorders in a subject as well as devices and kits for carrying out such methods.

IPC Classes  ?

  • G01N 33/86 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing involving blood coagulating time

14.

SAFE POINT PATTERN

      
Application Number 19004068
Status Pending
Filing Date 2024-12-27
First Publication Date 2025-06-05
Owner Roche Diagnostics Operations, Inc. (USA)
Inventor
  • Oosterbroek, Edwin
  • Schnarwiler, Dominik
  • Sillitoe, Nicolas Seungoon

Abstract

A method of operating a distribution system having carriers that carry objects and a transport plane supporting the carriers. A grid of logical positions is defined on the transport plane and a drive system moves the carriers between the logical positions. A router calculates routes for the carriers and applies a global pattern of safe points on the transport plane. Safe points are logical positions selected based on a range of motion for a carrier occupying the logical position, such that on the safe points a carrier can be placed and then moved away. The global pattern is applied onto the transport plane independently of module boundaries. Partial routes for the carriers are calculated so that an end position of each partial route is either a safe point or has a free path to a safe point to be reachable in the next partial route using the router.

IPC Classes  ?

  • G05D 1/692 - Coordinated control of the position or course of two or more vehicles involving a plurality of disparate vehicles
  • G05D 1/644 - Optimisation of travel parameters, e.g. of energy consumption, journey time or distance
  • G05D 101/00 - Details of software or hardware architectures used for the control of position
  • G05D 105/28 - Specific applications of the controlled vehicles for transportation of freight
  • G06Q 10/0835 - Relationships between shipper or supplier and carriers

15.

DISTRIBUTION SYSTEM AND METHOD FOR DISTRIBUTING A PLURALITY OF CARRIERS

      
Application Number 19004137
Status Pending
Filing Date 2024-12-27
First Publication Date 2025-06-05
Owner Roche Diagnostics Operations, Inc. (USA)
Inventor
  • Oosterbroek, Edwin
  • Sillitoe, Nicolas Seungoon

Abstract

A distribution system for distributing carriers has a transport plane with logical positions. The carriers transport objects and a drive system moves the carriers on the transport plane between the logical positions. A controller moves the carriers on a planned route from a start position to a final destination on the transport plane. The planned route is made up of partial routes, and a routing system calculates routing plans for carriers on the transport plane by modeling the transport plane with graphs of nodes. The routing plans are calculated considering moving time periods and waiting time periods. The waiting time periods are assigned based on a reservation of logical positions of the partial routes of other carriers. Thus, if a carrier experiences a time delay during execution of a move, the routing system shifts the experienced time delay to an upcoming waiting time period of a carrier.

IPC Classes  ?

  • G06Q 10/0835 - Relationships between shipper or supplier and carriers
  • G05D 1/644 - Optimisation of travel parameters, e.g. of energy consumption, journey time or distance
  • G05D 1/698 - Control allocation
  • G05D 101/00 - Details of software or hardware architectures used for the control of position
  • G05D 105/28 - Specific applications of the controlled vehicles for transportation of freight

16.

MUTANT REVERSE TRANSCRIPTASE WITH INCREASED THERMAL STABILITY AS WELL AS PRODUCTS, METHODS AND USES INVOLVING THE SAME

      
Application Number 19046511
Status Pending
Filing Date 2025-02-05
First Publication Date 2025-06-05
Owner Roche Diagnostics Operations, Inc. (USA)
Inventor
  • Bell, Christian Helmut
  • Sobek, Harald
  • Walch, Heiko
  • Yasukawa, Kiyoshi
  • Baba, Misato

Abstract

The present invention relates to a mutant reverse transcriptase (RT) with increased thermal stability relative to the wildtype, a nucleic acid encoding the mutant RT, a cell comprising the mutant RT or the nucleic acid, a kit comprising the mutant RT, the use of the mutant RT for cDNA synthesis, method for reverse transcription of RNA comprising synthesizing cDNA with the use of the mutant RT and a method for detecting an RNA marker in a sample with the use of the mutant RT.

IPC Classes  ?

  • C12N 9/12 - Transferases (2.) transferring phosphorus containing groups, e.g. kinases (2.7)
  • C12P 19/34 - Polynucleotides, e.g. nucleic acids, oligoribonucleotides
  • C12Q 1/68 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving nucleic acids

17.

DETECTION ZONE OF A LATERAL FLOW IMMUNOASSAY DEVICE COMPRISING A POLYION MULTILAYER

      
Application Number EP2024082830
Publication Number 2025/108930
Status In Force
Filing Date 2024-11-19
Publication Date 2025-05-30
Owner
  • F. HOFFMANN-LA ROCHE AG (Switzerland)
  • ROCHE DIAGNOSTICS GMBH (Germany)
  • ROCHE DIAGNOSTICS OPERATIONS, INC. (USA)
Inventor
  • Baeumner, Antje
  • Horn, Carina
  • Strohmaier-Nguyen, Dan

Abstract

A first aspect of the invention is directed to a detection zone of a lateral flow immunoassay device comprising a polyion multilayer, the polyion multilayer comprising (i) at least one layer comprising a complex of at least a first polyion and a first member of a binding pair; and (ii) at least one layer comprising a second polyion, which is oppositely charged with respect to the first polyion. In a second aspect, the invention relates to a lateral flow immunoassay device comprising a capillary channel, wherein the capillary channel houses (I) a detection zone as defined in the first aspect; (II) a first reagent zone, which comprises a labeled binding moiety; and (III) a second reagent zone, which comprises a binding moiety carrying a second member of a binding pair; wherein the binding moieties of (II) and of (III) are both capable of binding an analyte of interest, and the second member of a binding pair is capable of binding with the first member of a binding pair of the detection zone; wherein preferably first reagent zone of (II) and second reagent zone of (III) are spatially separated or overlap with each other at least partially. A third aspect of the invention is directed to the use of the lateral flow immunoassay device of the second aspect for determining an analyte in a sample. In a fourth aspect, the invention is related to a method for determining an analyte in a sample, the method comprising (a) contacting a sample with at least a labeled binding moiety and a binding moiety carrying a second member of a binding pair, thereby forming a mixture; (b) contacting the mixture formed in (a) with a polyion multilayer, the polyion multilayer comprising (i) at least one layer comprising a complex of at least a first polyion and a first member of a binding pair, (ii) at least one layer comprising a second polyion, thereby optionally forming complexes; (c) determining the amount of label containing complexes formed in (b); and (d) determining said analyte in a sample based on the result of step (c). A fifth aspect of the invention relates to a kit for determining an analyte in a sample, comprising the lateral flow immunoassay device of the second aspect and a pump, which is connected or connectable to the suction device.

IPC Classes  ?

  • G01N 33/543 - ImmunoassayBiospecific binding assayMaterials therefor with an insoluble carrier for immobilising immunochemicals

18.

A MULTI-SIGNAL METHOD FOR CALIBRATING AT LEAST ONE ANALYTE SENSOR FOR DETECTING AT LEAST ONE ANALYTE IN A SAMPLE

      
Application Number EP2024083076
Publication Number 2025/109050
Status In Force
Filing Date 2024-11-21
Publication Date 2025-05-30
Owner
  • ROCHE DIAGNOSTICS GMBH (Germany)
  • F. HOFFMANN-LA ROCHE AG (Switzerland)
  • ROCHE DIAGNOSTICS OPERATIONS, INC. (USA)
Inventor
  • Dagdelen, Oezguer
  • Doerr, Christopher
  • Leichsenring, Ingrid
  • Stickel, Manfred
  • Weisser, Steffen

Abstract

A method for calibrating at least one analyte sensor for detecting at least one analyte in a sample is proposed. The analyte sensor comprises at least one measurement unit configured for generating at least two at least partially independent sensor signals. Each of the independent sensor signals is dependent on a concentration of the analyte. The method comprises the following steps: a) (110) measuring at least two at least partially independent sensor signals (112, 114) by using the measurement unit on at least one reference sample having a known analyte concentration; b) (116) determining a multidimensional calibration trajectory (118) by combining the measured at least two at least partially independent sensor signals (112, 114) by using at least one processing unit.

IPC Classes  ?

  • G16H 40/40 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
  • A61B 5/00 - Measuring for diagnostic purposes Identification of persons

19.

METHOD OF COATING A GLASS FIBER FLEECE, COATED GLASS FIBER FILTER AND USES THEREOF

      
Application Number EP2024083324
Publication Number 2025/109187
Status In Force
Filing Date 2024-11-22
Publication Date 2025-05-30
Owner
  • F. HOFFMANN-LA ROCHE AG (Switzerland)
  • ROCHE DIAGNOSTICS GMBH (Germany)
  • ROCHE DIAGNOSTICS OPERATIONS, INC. (USA)
Inventor
  • Brandstetter, Thomas
  • Frey, Holger
  • Geid, Nicolas
  • Lopez-Calle, Eloisa
  • Marcinowski, Moritz
  • Ruehe, Juergen
  • Scherag, Frank Daniel
  • Spinke, Juergen

Abstract

The present invention relates to a method for coating a glass fiber fleece comprising contacting the surface of a glass fiber fleece with a hydrophilic copolymer; and crosslinking the copolymer. The invention further relates to a glass fiber filter, comprising a glass fiber fleece, wherein the surface of the glass fiber fleece is coated with a hydrophilic copolymer; and to a device for biomedical filter applications comprising the same.

IPC Classes  ?

  • B01D 67/00 - Processes specially adapted for manufacturing semi-permeable membranes for separation processes or apparatus
  • B01D 39/20 - Other self-supporting filtering material of inorganic material, e.g. asbestos paper or metallic filtering material of non-woven wires
  • B01D 69/10 - Supported membranesMembrane supports
  • B01D 71/40 - Polymers of unsaturated acids or derivatives thereof, e.g. salts, amides, imides, nitriles, anhydrides, esters
  • B01D 71/76 - Macromolecular material not specifically provided for in a single one of groups
  • G01N 33/49 - Physical analysis of biological material of liquid biological material blood
  • G01N 33/52 - Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper

20.

IVD ANALYZER, IVD CONSUMABLE DEVICE, AND METHOD OF USING THE SAME UNDER SUSCEPTIBILITY TO ENVIRONMENTAL CONDITIONS

      
Application Number EP2024081941
Publication Number 2025/103973
Status In Force
Filing Date 2024-11-12
Publication Date 2025-05-22
Owner
  • F. HOFFMANN-LA ROCHE AG (Switzerland)
  • ROCHE DIAGNOSTICS GMBH (Germany)
  • ROCHE DIAGNOSTICS OPERATIONS, INC. (USA)
Inventor
  • Hoertz, Christian
  • Diechtierow, Michael

Abstract

A kit comprising an in-vitro diagnostic (IVD) consumable device in an environmentally sealed package, where after opening of the package usability of the IVD consumable device by an IVD analyzer is time-limited within an out-of-package usability time period. The package comprises a package mark, the reading of which triggers the start of the out-of-package usability time period, and the IVD consumable device comprises a consumable-device mark, linked to the package mark, the reading of which determines a time lapse since reading of the package mark and whether the time lapse is within or outside of the out-of-package usability time period. A respective IVD analyzer and a respective method of using the kit together with the IVD analyzer, are herein also disclosed.

IPC Classes  ?

  • B01L 3/00 - Containers or dishes for laboratory use, e.g. laboratory glasswareDroppers
  • G01N 35/00 - Automatic analysis not limited to methods or materials provided for in any single one of groups Handling materials therefor
  • G16H 10/40 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis

21.

IVD SYSTEM AND METHOD OF USING AN IVD CONSUMABLE DEVICE SUSCEPTIBLE TO ENVIRONMENTAL CONDITIONS

      
Application Number EP2024081927
Publication Number 2025/103968
Status In Force
Filing Date 2024-11-12
Publication Date 2025-05-22
Owner
  • F. HOFFMANN-LA ROCHE AG (Switzerland)
  • ROCHE DIAGNOSTICS GMBH (Germany)
  • ROCHE DIAGNOSTICS OPERATIONS, INC. (USA)
Inventor
  • Hoertz, Christian
  • Juergens, Ludger Herbert Joachim

Abstract

An IVD system comprising an IVD analyzer and an IVD consumable device configured to be used together with the IVD analyzer in order to carry out an IVD test that enables to obtain reliable test results by more reliably determining whether the IVD consumable device is within or outside of an out-of-package usability time period. In particular, the IVD analyzer comprises an optical detector for determining an optically detectable property of at least one indicator, at least one environmental sensor configured to determine a value of at least one environmental parameter affecting change of the optically detectable property over time and a controller configured to correlate the optically detected property of the at least one indicator to the determined value of the at least one environmental parameter by reference to a stored indicator-specific calibration of the optically detectable property obtained under varying values of the at least one environmental parameter.

IPC Classes  ?

  • G01N 31/22 - Investigating or analysing non-biological materials by the use of the chemical methods specified in the subgroupsApparatus specially adapted for such methods using chemical indicators
  • G01N 21/78 - Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator producing a change of colour
  • G01N 21/84 - Systems specially adapted for particular applications
  • G04F 13/00 - Apparatus for measuring unknown time intervals by means not provided for in groups

22.

TRANSGLUTAMINASE SUBSTRATES FOR LABELING

      
Application Number 18506002
Status Pending
Filing Date 2023-11-09
First Publication Date 2025-05-15
Owner Roche Diagnostics Operations, Inc. (USA)
Inventor
  • Jochum, Simon
  • Hemann, Matthias
  • Benz, Juliane

Abstract

Fusion polypeptides are disclosed which are substrates for Kutzneria albida transglutaminase. The fusion polypeptides comprise one or more FKBP chaperone(s) and a target polypeptide. Each of these elements is separated from the neighboring element by a linker amino acid sequence. It was found that inserting glutamic acid containing transglutaminase recognition motifs into the linker amino acid chains is advantageous. Subsequent labeling reactions catalyzed by the transglutaminase surprisingly provide labeled fusion polypeptides have superior properties when compared with chemically random-labeled fusion polypeptides of similar design. Assays and kits are provided for in vitro detection of target antibodies in samples.

IPC Classes  ?

  • G01N 33/569 - ImmunoassayBiospecific binding assayMaterials therefor for microorganisms, e.g. protozoa, bacteria, viruses
  • C07K 14/005 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from viruses
  • C12N 9/10 - Transferases (2.)
  • G01N 33/532 - Production of labelled immunochemicals

23.

HIGH AFFINITY ANTIBODIES SPECIFICALLY BINDING TO a-1,6-CORE-FUCOSYLATED ALPHA-FETOPROTEIN

      
Application Number 18951180
Status Pending
Filing Date 2024-11-18
First Publication Date 2025-05-15
Owner Roche Diagnostics Operations, Inc. (USA)
Inventor
  • Gerg, Michael
  • Hillringhaus, Lars
  • Jucknischke, Ute
  • Muth, Anna Christine
  • Oelschlaegel, Tobias
  • Pinchuk, Boris
  • Schraeml, Michael
  • Siebenhaar, Joanna
  • Thirault, Laurence

Abstract

The present invention relates to monoclonal antibodies and antigen binding fragments that specifically bind to α-1,6-core-fucosylated alpha-fetoprotein (AFP), which is the core component of AFP-L3. Thus, the antibodies and antigen binding fragments provided herein may also be referred to as AFP-L3 antibodies. Also provided are polynucleotides encoding the antibodies or antigen binding fragments of the invention, host cells expressing the antibodies and antigen binding fragments of the invention, methods for producing the antibodies and antigen binding fragments of the invention, and uses of the antibodies and antigen binding fragments of the invention. Also provided herein is a pretreatment agent facilitating the binding of the antibodies and antigen binding fragments of the invention to α-1,6-core-fucosylated AFP. The present invention further relates to kits comprising the antibodies and antigen binding fragments of the invention and optionally the pretreatment agent of the invention.

IPC Classes  ?

  • G01N 33/574 - ImmunoassayBiospecific binding assayMaterials therefor for cancer
  • C07K 16/18 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans

24.

Parts Anomaly Detection System, Automatic Analyzer and Parts Anomaly Detection Method

      
Application Number 18834169
Status Pending
Filing Date 2022-12-14
First Publication Date 2025-05-15
Owner
  • Hitachi High-Tech Corporation (Japan)
  • Roche Diagnostics Operations, Inc. (USA)
Inventor
  • Sasaki, Shunsuke
  • Imai, Kenta
  • Hadorn, Maik Roger
  • Kuehnl, Michael
  • Pukas, Darius
  • Brzezinski, Mikolaj
  • Marchewa, Janusz

Abstract

Such a parts anomaly detection system is provided as being able to detect the anomaly of the parts of the liquid transport system of the automatic analyzer without delay. Such a parts anomaly detection system is provided as being able to detect the anomaly of the parts of the liquid transport system of the automatic analyzer without delay. The parts anomaly detection system to detect the anomaly of the parts of the liquid transport system (22) which absorbs and discharges liquid with respect to a sensor (21) for sample inspection of an automatic analyzer (1) comprises: storage devices (31, 41) to store data of electric signals outputted by the sensor and processing devices (32, 42) to process the data recorded in the storage devices, in which the processing devices detect the anomaly of the parts of the liquid transport system based on the electric signals.

IPC Classes  ?

  • G01N 35/00 - Automatic analysis not limited to methods or materials provided for in any single one of groups Handling materials therefor

25.

INSERT, CENTRIFUGE, AND ANALYTICAL INSTRUMENT

      
Application Number 18944098
Status Pending
Filing Date 2024-11-12
First Publication Date 2025-05-15
Owner Roche Diagnostics Operations, Inc. (USA)
Inventor
  • Bauer, Andreas
  • Hess, Peter
  • Stein, Reiner
  • Thome, Klaus
  • Gruen, Markus
  • Gruber, Benjamin
  • Elengical, John

Abstract

The invention relates to an insert being adapted to be removably inserted into a ring segment shaped gap of a centrifuge, wherein the ring segment shaped gap is formed between a rotor member and a stator member of the centrifuge, wherein the insert is adapted to collect fluids centrifugally ejected from the rotor member.

IPC Classes  ?

  • B01L 3/00 - Containers or dishes for laboratory use, e.g. laboratory glasswareDroppers
  • G01N 1/40 - Concentrating samples

26.

CALIBRATION TARGET, ANALYTICAL DEVICE, METHOD, AND USE

      
Application Number EP2024081145
Publication Number 2025/098972
Status In Force
Filing Date 2024-11-05
Publication Date 2025-05-15
Owner
  • ROCHE DIAGNOSTICS GMBH (Germany)
  • F. HOFFMANN-LA ROCHE AG (Switzerland)
  • ROCHE DIAGNOSTICS OPERATIONS, INC. (USA)
Inventor Hebestreit, Kai

Abstract

The invention relates to a calibration target (1) for calibrating an analytical device (20), wherein the calibration target (1) comprises an electrophoretic display (2) comprising first particles (P1) and second particles (P2), wherein the first particles (P1) and the second particles (P2) differ in at least one property, wherein the electrophoretic display (2) is controllable for displaying a calibration image (I) using the first particles (P1) and/or the second particles (P2).

IPC Classes  ?

  • G02F 1/167 - Devices or arrangements for the control of the intensity, colour, phase, polarisation or direction of light arriving from an independent light source, e.g. switching, gating or modulatingNon-linear optics for the control of the intensity, phase, polarisation or colour based on translational movement of particles in a fluid under the influence of an applied field characterised by the electro-optical or magneto-optical effect by electrophoresis
  • G01N 21/27 - ColourSpectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands using photo-electric detection
  • G02F 1/1675 - Constructional details

27.

Method of operating a laboratory sample distribution system, laboratory sample distribution system, and laboratory automation system

      
Application Number 19017141
Status Pending
Filing Date 2025-01-10
First Publication Date 2025-05-08
Owner Roche Diagnostics Operations, Inc. (USA)
Inventor
  • Janner, Gabriele Piero
  • Ng, Cho Yiu
  • Ren, Shubin

Abstract

The disclosure refers to a method of operating a laboratory sample distribution system having: a plurality of carriers (4) having a number of n (n>3) carriers (4) each configured to carry one or more sample containers containing a sample to be analyzed by laboratory devices (3); a transport plane (1) configured to support to the plurality of carriers (4), wherein the transport plane (1) comprises a plurality of interconnected transport modules comprising a plurality of plane fields (5); and a driving device (13) configured to control movement of the plurality of carriers (4) along individual routes between the plurality of plane fields (5). The method comprises: moving the plurality of carriers (4) along the individual routes on the transport plane (1), wherein the moving, for each carrier, comprises executing at least once steps of reserving a route segment along the individual route, the route segment being provided by one or more plane fields of the plurality of plane fields (5), and moving the carrier (4) along the route segment; and preventing, for the plurality of carriers (4), a deadlock arrangement on the transport plane in which the plurality of carriers (4) block each other from further movement along the individual routes (6). The preventing is further comprising: determining, at a present operation time, a potential deadlock arrangement for the plurality of carriers (4) on the transport plane (1) at a future operation time, wherein the potential deadlock arrangement is assigned a number of n deadlock plane fields occupied by the plurality of carriers (4) in case of the potential deadlock arrangement; for a first carrier from the plurality of carriers (4) moving along a first individual route, reserving a first route segment ending with a first end plane field; and assigning a non-reserve flag to a next plane field which is next to the first end plane field along the first individual route. Further, a laboratory sample distribution system, and a laboratory automation system are provided.

IPC Classes  ?

  • G01N 35/04 - Details of the conveyor system
  • G01N 35/00 - Automatic analysis not limited to methods or materials provided for in any single one of groups Handling materials therefor

28.

TRANSGLUTAMINASE SUBSTRATES FOR LABELING

      
Application Number 18505075
Status Pending
Filing Date 2023-11-08
First Publication Date 2025-05-08
Owner Roche Diagnostics Operations, Inc. (USA)
Inventor
  • Jochum, Simon
  • Hemann, Matthias
  • Benz, Juliane

Abstract

Fusion polypeptides are disclosed which are substrates for Kutzneria albida transglutaminase. The fusion polypeptides comprise one or more FKBP chaperone(s) and a target polypeptide. Each of these elements is separated from the neighboring element by a linker amino acid sequence. It was found that inserting glutamic acid containing transglutaminase recognition motifs into the linker amino acid chains is advantageous. Subsequent labeling reactions catalyzed by the transglutaminase surprisingly provide labeled fusion polypeptides have superior properties when compared with chemically random-labeled fusion polypeptides of similar design. Assays and kits are provided for in vitro detection of target antibodies in samples.

IPC Classes  ?

  • G01N 33/569 - ImmunoassayBiospecific binding assayMaterials therefor for microorganisms, e.g. protozoa, bacteria, viruses
  • C12N 9/10 - Transferases (2.)
  • G01N 33/68 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing involving proteins, peptides or amino acids

29.

GLYCAN STRUCTURES OF HAPTOGLOBIN AS A BIOMARKER OF HEPATOCELLULAR CARCINOMA

      
Application Number 18931012
Status Pending
Filing Date 2024-10-29
First Publication Date 2025-05-08
Owner Roche Diagnostics Operations, Inc. (USA)
Inventor
  • Busskamp, Holger
  • Kohansal Nodehi, Mahdokht
  • Kroeniger, Konstantin
  • Rolny, Vinzent
  • Swiatek-De Lange, Magdalena
  • Tabares, Gloria

Abstract

The present invention relates to in vitro methods for aiding in the detection of hepatocellular carcinoma (HCC) in a subject comprising determining the amount of one or more glycan structure at position N207 of haptoglobin (i.e. of the ß-chain of haptoglobin having the sequence given in SEQ ID NO: 1) in a sample obtained from said subject. Also disclosed are a glycan structure as well as a glycopeptide comprising said glycan structure, both of great utility in the detection of HCC. Further, the present invention relates to the use of one or more glycan structure at position N207 or of a glycopeptide comprising N207 of haptoglobin in combination with AFP and/or PIVKA in the detection of HCC.

IPC Classes  ?

  • G16H 50/30 - ICT specially adapted for medical diagnosis, medical simulation or medical data miningICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for calculating health indicesICT specially adapted for medical diagnosis, medical simulation or medical data miningICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for individual health risk assessment
  • C07K 7/06 - Linear peptides containing only normal peptide links having 5 to 11 amino acids
  • C12Q 1/37 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving hydrolase involving peptidase or proteinase
  • G01N 33/574 - ImmunoassayBiospecific binding assayMaterials therefor for cancer
  • G01N 33/68 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing involving proteins, peptides or amino acids

30.

REMOTE ANALYZER MONITORING

      
Application Number 18936946
Status Pending
Filing Date 2024-11-04
First Publication Date 2025-05-08
Owner
  • Roche Diagnostics International AG (Switzerland)
  • Roche Diagnostics Operations, Inc. (USA)
Inventor
  • Alexander, Jeffrey
  • Hoogendoorn, Geertje Engelina Adriana Maria
  • Lin, Yi-Chun
  • Winiarz, Jakub

Abstract

A computer implemented method (60) for remote analyzer monitoring, comprising: obtaining (62), via a computing device (20) comprising a camera (21), visual representation data (70) of at least a display interface (P1-D) of an automated analyzer (P1) after the automated analyzer (P1) has performed a predefined operation, wherein the visual representation data (70) of the display interface (P1-D) comprises data associated with an outcome of the predefined operation performed by the automated analyzer (P1); processing (64) the visual representation data to extract data (74) relating to an outcome of the predefined operation computed by the automated analyzer (P1) and comprised in the visual representation data (70) associated with the predefined operation; evaluating (66) the data associated with the predefined operation according to at least one evaluation criterion to thus generate evaluation data (76); and storing (68) the evaluation data associated with the predefined operation.

IPC Classes  ?

  • G01N 35/00 - Automatic analysis not limited to methods or materials provided for in any single one of groups Handling materials therefor

31.

METHOD FOR CONFIGURATION MANAGEMENT OF AT LEAST ONE LABORATORY ANALYZER SYSTEM

      
Application Number EP2024080556
Publication Number 2025/093539
Status In Force
Filing Date 2024-10-29
Publication Date 2025-05-08
Owner
  • F. HOFFMANN-LA ROCHE AG (Switzerland)
  • ROCHE DIAGNOSTICS GMBH (Germany)
  • ROCHE DIAGNOSTICS OPERATIONS, INC. (USA)
Inventor
  • Roetzer, Marian David
  • Schweinberger, Florian Frank

Abstract

A computer-implemented method for configuration management of at least one laboratory analyzer system (114) comprising at least one analytical unit (116) is proposed. The method comprises the following steps: a) retrieving at least one item of information on an analytical unit configuration of at least one analytical unit (116) of the laboratory analyzer system (114); b) applying at least one cryptographic function to the item of information on an analytical unit configuration thereby generating a secured item of information on an analytical unit configuration; c) providing the secured item of information on an analytical unit configuration to at least one database (122) of the laboratory analyzer system (114) and/or to at least one remote central database (118), wherein the remote central database (118) is at the manufacturer's site and/or a cloud database.

IPC Classes  ?

  • G06F 21/57 - Certifying or maintaining trusted computer platforms, e.g. secure boots or power-downs, version controls, system software checks, secure updates or assessing vulnerabilities
  • G16H 40/40 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
  • H04L 9/32 - Arrangements for secret or secure communicationsNetwork security protocols including means for verifying the identity or authority of a user of the system

32.

COBAS ULTIMATE

      
Serial Number 99165410
Status Pending
Filing Date 2025-05-01
Owner Roche Diagnostics Operations, Inc. ()
NICE Classes  ?
  • 09 - Scientific and electric apparatus and instruments
  • 10 - Medical apparatus and instruments

Goods & Services

Laboratory instrument for the analysis of biological samples for the presence, absence, or quantity of medically significant analytes for use in research, science and industry; computer hardware and software for use with laboratory instruments, namely, for use in providing automation of laboratory processes, control and monitoring of laboratory instruments, connectivity, data analysis, and data management Medical apparatus for the analysis of biological samples for the presence, absence, or quantity of medically significant analytes for medical diagnostic purposes

33.

COBAS SMART

      
Serial Number 99165444
Status Pending
Filing Date 2025-05-01
Owner Roche Diagnostics Operations, Inc. ()
NICE Classes  ?
  • 09 - Scientific and electric apparatus and instruments
  • 10 - Medical apparatus and instruments

Goods & Services

Laboratory instrument for the analysis of biological samples for the presence, absence, or quantity of medically significant analytes for use in research, science and industry; computer hardware and downloadable software for use with laboratory instruments, namely, for use in providing automation of laboratory processes, control and monitoring of laboratory instruments, connectivity, data analysis, and data management Medical apparatus for the analysis of biological samples for the presence, absence, or quantity of medically significant analytes for medical diagnostic purposes

34.

GLYCAN STRUCTURES OF HAPTOGLOBIN AS A BIOMARKER OF HEPATOCELLULAR CARCINOMA

      
Application Number 18930774
Status Pending
Filing Date 2024-10-29
First Publication Date 2025-05-01
Owner Roche Diagnostics Operations, Inc. (USA)
Inventor
  • Rolny, Vinzent
  • Busskamp, Holger
  • Kroeniger, Konstantin
  • Kohansal Nodehi, Mahdokht
  • Swiatek-De Lange, Magdalena
  • Tabares, Gloria

Abstract

The present invention relates to in vitro methods for aiding in the detection of hepatocellular carcinoma (HCC) in a subject. The method may comprise determining the amount of one or more N-glycan structure attached to haptoglobin (i.e. of the β-chain of haptoglobin having the sequence given in SEQ ID NO: 1) in a sample obtained from said subject and comparing the amount of said one or more glycan structure to a reference amount of said one or more glycan structure, wherein an altered amount of said one or more glycan structure in said patient sample relative to the reference amount of said one or more glycan structure is indicative for HCC. Further, the present invention relates to the use of one or more glycan structure attached to haptoglobinor of a glycopeptide derived from haptoglobin in combination with AFP and/or PIVKA-II in the detection of HCC.

IPC Classes  ?

  • G01N 33/574 - ImmunoassayBiospecific binding assayMaterials therefor for cancer
  • G01N 33/68 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing involving proteins, peptides or amino acids

35.

COMPOUNDS FOR STABILIZING PEPTIDES IN BIOLOGICAL SAMPLES

      
Application Number EP2024079880
Publication Number 2025/087937
Status In Force
Filing Date 2024-10-23
Publication Date 2025-05-01
Owner
  • F. HOFFMANN-LA ROCHE AG (Switzerland)
  • ROCHE DIAGNOSTICS GMBH (Germany)
  • ROCHE DIAGNOSTICS OPERATIONS, INC. (USA)
Inventor
  • Pirkl, Nicole
  • Rempt, Martin

Abstract

The present invention provides the use of a sulfone compound for stabilizing a peptide in a sample. Also provided is a corresponding method comprising adding a sulfone compound to a sample for stabilizing the peptide. Also provided is a vessel for collecting a sample comprising a peptide, wherein said vessel comprises a sulfone compound. Provided herein is further a composition comprising a peptide and a sulfone compound, a kit comprising a sulfone compound, a vessel of the invention or a composition of the invention. Finally, the present invention also relates to the use of a sulfone compound for inhibiting a protease.

IPC Classes  ?

  • C12Q 1/37 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving hydrolase involving peptidase or proteinase

36.

COBAS ULTRA

      
Serial Number 99163366
Status Pending
Filing Date 2025-04-30
Owner Roche Diagnostics Operations, Inc. ()
NICE Classes  ?
  • 09 - Scientific and electric apparatus and instruments
  • 10 - Medical apparatus and instruments

Goods & Services

Laboratory instrument for the analysis of biological samples for the presence, absence, or quantity of medically significant analytes for use in research, science and industry; computer hardware and downloadable software for use with laboratory instruments, namely, for use in providing automation of laboratory processes, control and monitoring of laboratory instruments, connectivity, data analysis, and data management Medical apparatus for the analysis of biological samples for the presence, absence, or quantity of medically significant analytes for medical diagnostic purposes

37.

COBAS TRUE

      
Serial Number 99163440
Status Pending
Filing Date 2025-04-30
Owner Roche Diagnostics Operations, Inc. ()
NICE Classes  ?
  • 09 - Scientific and electric apparatus and instruments
  • 10 - Medical apparatus and instruments

Goods & Services

Laboratory instrument for the analysis of biological samples for the presence, absence, or quantity of medically significant analytes for use in research, science and industry; computer hardware and downloadable software for use in providing automation of laboratory processes, control and monitoring of laboratory instruments, connectivity, data analysis, and data management Medical apparatus for the analysis of biological samples for the presence, absence, or quantity of medically significant analytes for medical diagnostic purposes

38.

COBAS CLICK

      
Serial Number 99163488
Status Pending
Filing Date 2025-04-30
Owner Roche Diagnostics Operations, Inc. ()
NICE Classes  ?
  • 05 - Pharmaceutical, veterinary and sanitary products
  • 10 - Medical apparatus and instruments

Goods & Services

Chemical, biochemical and biological reagents for medical and diagnostic purposes; diagnostic reagents for clinical medical and diagnostic purposes; reagents for in-vitro laboratory use for medical purposes Medical apparatus, namely, clinical chemistry analyzers for use in the analysis of biological samples for the presence, absence, or quantity of medically significant analytes for clinical medical diagnostic purposes

39.

METHOD FOR DIAGNOSING ENDOMETRIOSIS AND FOR CLASSIFYING THE STAGE OF ENDOMETRIOSIS

      
Application Number 18999357
Status Pending
Filing Date 2024-12-23
First Publication Date 2025-04-24
Owner Roche Diagnostics Operations, Inc. (USA)
Inventor
  • Flohr, Aljoscha Michael
  • Georgopoulou, Aikaterini
  • Guennoun, Rym
  • Hund, Martin
  • Klammer, Martin

Abstract

The present invention relates to methods of diagnosing whether a subject has endometriosis, to methods of classifying the stage of endometriosis, to methods of determining the therapeutic effect of a treatment regimen for endometriosis, and methods of monitoring endometriosis progression in a subject, by determining the amount or concentration of c-Kit in a sample of the subject, and comparing the determined level to a reference value.

IPC Classes  ?

  • G01N 33/68 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing involving proteins, peptides or amino acids

40.

AN IVA TEST UNIT, A TEST SET COMPRISING THE IVA TEST UNIT AND A METHOD OF PRODUCING THE SAME

      
Application Number EP2024078092
Publication Number 2025/078295
Status In Force
Filing Date 2024-10-07
Publication Date 2025-04-17
Owner
  • F. HOFFMANN-LA ROCHE AG (Switzerland)
  • ROCHE DIAGNOSTICS GMBH (Germany)
  • ROCHE DIAGNOSTICS OPERATIONS, INC. (USA)
Inventor
  • Blum, Martin
  • Isgoeren, Yilmaz
  • Meyer Dos Santos, Sascha

Abstract

IVA test unit (1) comprising: a test strip (2) for detecting an analyte, wherein the test strip comprises at least an application function, a test reaction function and a test detection function; and a housing (3) for storing the test strip (2) wherein the housing (3) comprises an insert tray (4) and an insert hole (5) for inserting the test strip (2) into the insert tray (4), characterized in that the housing (3) is formed as one single piece.

IPC Classes  ?

41.

ELUTION KIT, ANALYTICAL KIT AND METHOD OF ELUTING AND ANALYZING A BIOLOGICAL SAMPLE

      
Application Number EP2024078090
Publication Number 2025/078294
Status In Force
Filing Date 2024-10-07
Publication Date 2025-04-17
Owner
  • F. HOFFMANN-LA ROCHE AG (Switzerland)
  • ROCHE DIAGNOSTICS GMBH (Germany)
  • ROCHE DIAGNOSTICS OPERATIONS, INC. (USA)
Inventor
  • Blum, Martin
  • Isgoeren, Yilmaz
  • Meyer Dos Santos, Sascha

Abstract

An elution kit (1) for eluting a biological sample in a liquid (2) and dispensing the eluted sample liquid (2') onto a test element (102) of an analytical kit (101), the elution kit (1) comprises: a sample collection swab (3) for collecting the biological sample, wherein the sample collection swab (3) comprises a stick portion (4) for being hand-held and a deformable head portion (5) on the stick portion (4) for collecting the biological sample, wherein the head portion (5) is porous for the liquid (2); and an elution liquid tube (6) which comprises: an interior space (7) for housing the liquid (2), receiving the sample collection swab (3) and eluting the biological sample in the liquid (2); an insertion opening (10) on a first side of the interior space (7) for inserting the sample collection swab (3) into the interior space (7); a dispense opening (11) on a second side of the interior space (7) adjacent the first side for dispensing the eluted sample liquid; a first closure element (12) to seal the dispense opening (11) in a water-vapor impermeable manner; a second closure element (13) to seal the insertion opening (10) in a water-vapor impermeable manner, wherein the first closure element (12) and/or the second closure element (13) comprises a foil; and the liquid (2), wherein the elution liquid tube (6) contains the liquid (2), wherein the interior space (7) is defined by an inner surface (8) that comprises an elution zone (16) with at least one elution portion (9) having a smallest side-to-side distance y ranging between approximately 70% and 140% of a largest side-to-side distance x of the head portion (5) of the sample collection swab (3) and defining a gap (14) through which the sample collection swab (3) can be pushed and pulled in a closed state of the dispense opening (11).

IPC Classes  ?

  • B01L 3/00 - Containers or dishes for laboratory use, e.g. laboratory glasswareDroppers
  • B01L 3/02 - BurettesPipettes

42.

REAGENT FORMULATION FOR MASS AXIS CHECK AND ADJUSTMENT

      
Application Number 18694874
Status Pending
Filing Date 2022-09-21
First Publication Date 2025-04-10
Owner Roche Diagnostics Operations, Inc. (USA)
Inventor Lang, Robert

Abstract

The present invention relates to a composition comprising (i) cesium iodide, (ii) ethylamine and/or formic acid, and (iii) methanol and/or water. The present invention further relates to a method for calibrating a mass spectrometry (MS) device comprising (I) determining a mass spectrum of a composition as specified; and (II) calibrating the MS device based on the mass spectrum determined in step (I). The present invention further relates to devices, kits, uses, and methods related thereto.

IPC Classes  ?

43.

MEANS AND METHODS APPLYING sFlt-1/PIGF OR ENDOGLIN/PIGF RATIO TO RULE OUT ONSET OF PREECLAMPSIA WITHIN A CERTAIN TIME PERIOD

      
Application Number 18798760
Status Pending
Filing Date 2024-08-08
First Publication Date 2025-04-10
Owner Roche Diagnostics Operations, Inc. (USA)
Inventor
  • Hund, Martin
  • Schoedl, Maria

Abstract

The present invention concerns the field of diagnostic assays for prenatal diagnosis of preeclampsia. In particular, it relates to a method for diagnosing whether a pregnant subject is not at risk for preeclampsia within a short window of time comprising a) determining the amount of at least one angiogenesis biomarker selected from the group consisting of sFlt-1, Endoglin and PlGF in a sample of said subject, and b) comparing the amount with a reference, whereby a subject being not at risk for developing preeclampsia within a short period of time is diagnosed if the amount is identical or decreased compared to the reference in the cases of sFlt-1 and Endoglin and identical or increased in the case of PlGF, wherein said reference allows for making the diagnosis with a negative predictive value of at least about 98%. Further contemplates are devices and kits for carrying out said method.

IPC Classes  ?

  • G01N 33/68 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing involving proteins, peptides or amino acids
  • G16H 50/30 - ICT specially adapted for medical diagnosis, medical simulation or medical data miningICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for calculating health indicesICT specially adapted for medical diagnosis, medical simulation or medical data miningICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for individual health risk assessment
  • G16H 50/70 - ICT specially adapted for medical diagnosis, medical simulation or medical data miningICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for mining of medical data, e.g. analysing previous cases of other patients

44.

METHODS FOR MANAGEMENT OF PROSTATE CANCER

      
Application Number 18908787
Status Pending
Filing Date 2024-10-07
First Publication Date 2025-04-10
Owner Roche Diagnostics Operations, Inc. (USA)
Inventor
  • Cobbaert, Christa
  • Kroeniger, Konstantin
  • Lageveen-Kammeijer, Guinevere
  • Nouta, Jan
  • Rolny, Vinzent
  • Ruhaak, Renee
  • Swiatek-De Lange, Magdalena
  • Tabares, Gloria
  • Van Der Burgt, Yuri
  • Wuhrer, Manfred

Abstract

The present invention relates to methods for assessing whether or not a patient has aggressive prostate cancer by determining the levels of particular glycoforms attached to prostate specific antigen (PSA) protein in a biofluid sample of a subject, and comparing the determined level or concentration to a reference. The methods are particularly useful for assessing subjects that have 2-10 ng/ml total PSA in the subject's serum.

IPC Classes  ?

  • G01N 33/574 - ImmunoassayBiospecific binding assayMaterials therefor for cancer
  • G01N 33/573 - ImmunoassayBiospecific binding assayMaterials therefor for enzymes or isoenzymes

45.

COBAS LUMIRA

      
Serial Number 99117674
Status Pending
Filing Date 2025-04-02
Owner Roche Diagnostics Operations, Inc. ()
NICE Classes  ?
  • 05 - Pharmaceutical, veterinary and sanitary products
  • 10 - Medical apparatus and instruments

Goods & Services

Chemical, biological and biochemical preparations for the analysis of biological samples for medical purposes; medical diagnostic assays and reagents for the analysis of biological samples for clinical or medical purposes; diagnostic reagents and preparations for medical purposes; in vitro diagnostic agents for the analysis of biological samples for medical purposes; all of the foregoing excluding active pharmaceutical ingredients, isotopes and radioisotopes Analyzers for the analysis of biological samples for medical diagnostic purposes; in vitro diagnostic devices in the nature of biosensors for the detection and analysis of medically significant analytes in biological samples for medical purposes

46.

DETERMINING LIKELIHOOD OF KIDNEY FAILURE

      
Application Number 18728195
Status Pending
Filing Date 2023-01-24
First Publication Date 2025-03-27
Owner Roche Diagnostics Operations, Inc. (USA)
Inventor
  • Danzer, Carsten
  • Emons, Martin Josef
  • Klammer, Martin
  • Sillitoe, Nicolas Seungoon
  • Triunfo, Riccardo

Abstract

A computer-implemented method is provided, which determines at a prediction time tp, a likelihood of kidney failure of a patient within an amount of time Δt. The method comprises receiving input data, the input data comprising a recent creatinine level cR or recent eGFR eGFRR, and one or more of the following: (a) an initial creatinine level c0 and either: a time t0 at which the initial creatinine level c0 was measured, or a time interval ΔT0=tp−t0; (b) an initial estimated glomerular filtration rate (eGFR) eGFR0 and either: a time t0 at which the initial eGFR was determined, or a time interval ΔT0=tp−t0; (c) for a plurality of past creatinine level measurements ci measured at a respective times ti, a statistical parameter derived from a linear regression of the plurality of past creatinine level measurements; and (d) for a plurality of past eGFR values eGFRi determined at respective times ti, a statistical parameter derived from a linear regression of the plurality of past eGFR values; and applying a machine-learning model to the input data to generate an output indicating the likelihood of kidney failure within the given amount of time Δt. Corresponding training methods and systems are also provided.

IPC Classes  ?

  • A61B 5/20 - Measuring urological functions
  • A61B 5/00 - Measuring for diagnostic purposes Identification of persons
  • G16H 10/60 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records
  • G16H 50/20 - ICT specially adapted for medical diagnosis, medical simulation or medical data miningICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems

47.

THERMAL CONTROL DEVICE FOR TEMPERATURE CYCLING, METHOD FOR CONTROLLING TEMPERATURE CYCLING USING A THERMAL CONTROL DEVICE, AND SYSTEM FOR CONTROLLING TEMPERATURE OF A SAMPLE USING A THERMAL CONTROL DEVICE

      
Application Number EP2024076377
Publication Number 2025/061910
Status In Force
Filing Date 2024-09-20
Publication Date 2025-03-27
Owner
  • ROCHE DIAGNOSTICS GMBH (Germany)
  • F. HOFFMANN-LA ROCHE AG (Switzerland)
  • ROCHE DIAGNOSTICS OPERATIONS, INC. (USA)
Inventor
  • Fischer, Simon
  • Sangermano, Marco
  • Wiget, Pascal

Abstract

In one embodiment, a thermal control device (110) adapted for temperature cycling is provided. The thermal control device (110) comprises a thermally conductive heat spreader layer (118) comprising a first side surface and a second side surface. A heater circuit (120) is disposed adjacent to and in thermal contact with at least one of the first side surface and the second side surface of the thermally conductive heat spreader layer (118). At least one thermal interface material layer (114) is disposed adjacent to and in thermal contact with one of the first side surface and the second side surface of the thermally conductive heat spreader layer (118). A cooling block (116) is disposed adjacent to and in thermal contact with the thermal interface material layer (114). The cooling block (116) is adapted to conduct heat energy away from the thermally conductive heat spreader layer (118). A controller is coupled to and adapted to control the heater circuit (120). In another embodiment, a diagnostic test device is provided.

IPC Classes  ?

  • B01L 7/00 - Heating or cooling apparatusHeat insulating devices

48.

CLASSIFICATION METHOD FOR CLASSIFYING SYSTEMIC INFLAMMATORY STATES

      
Application Number EP2024075599
Publication Number 2025/056737
Status In Force
Filing Date 2024-09-13
Publication Date 2025-03-20
Owner
  • F. HOFFMANN-LA ROCHE AG (Switzerland)
  • ROCHE DIAGNOSTICS GMBH (Germany)
  • ROCHE DIAGNOSTICS OPERATIONS, INC. (USA)
Inventor
  • Bundschus, Markus
  • Schoedl, Thomas
  • Wohlfart, Christian

Abstract

A computer-implemented training method (110) of training at least one trainable model is disclosed for classifying a patient's health condition into a systemic inflammatory state (168, 170, 172) selected from a predetermined group of at least three systemic inflammatory states (168, 170, 172). The method comprises: a. providing the trainable model; b. retrieving labeled training patient data, the training patient data comprising gene expression data of patients having known systemic inflammatory states (168, 170, 172); and c. training the trainable model on the labeled training patient data. Further disclosed is a computer-implemented classification method (112) of classifying a patient's health condition into a systemic inflammatory state (168, 170, 172) selected from a predetermined group of at least three systemic inflammatory states (168, 170, 172) and systems, computer programs and computer-readable storage media for performing the methods.

IPC Classes  ?

  • G16B 25/10 - Gene or protein expression profilingExpression-ratio estimation or normalisation
  • G16B 40/20 - Supervised data analysis
  • G16H 50/20 - ICT specially adapted for medical diagnosis, medical simulation or medical data miningICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems

49.

METHOD FOR ASSESSING SYSTEMIC INFLAMMATION

      
Application Number EP2024075667
Publication Number 2025/056769
Status In Force
Filing Date 2024-09-13
Publication Date 2025-03-20
Owner
  • ROCHE DIAGNOSTICS GMBH (Germany)
  • F. HOFFMANN-LA ROCHE AG (Switzerland)
  • ROCHE DIAGNOSTICS OPERATIONS, INC. (USA)
Inventor
  • Bundschus, Markus
  • Schoedl, Thomas
  • Wohlfart, Christian

Abstract

The present invention relates to the field of diagnostics. In particular, it relates to a method for assessing systemic inflammation in a subject exhibiting symptoms thereof comprising a) determining in a sample of said subject the amounts of biomarkers from a group of biomarkers selected from i) a first group of biomarkers comprising: POMK, NEK6, KCNA5, LARGE2, ZNF425, NACA2, CFAP57, SPINT1, ZNF492, and S100A6, ii) a second group of biomarkers comprising: NEK6, SRPK3, TNFSF8, S100A6, NMUR1, DHFR, HIST1H4D, ZDHHC4, TRAF3, and SGMSlor iii) a third group of biomarkers comprising: C9orfl35, ZNF425, ACOT4, SPDYA, DAPP1, LY86, ZPBP2, RPL3L, UPK1B, and APBB3, b) comparing said determined amounts of biomarkers from said group of biomarkers to a reference, and c) assessing systemic inflammation in the subject. Further, the present invention, in general, relates to the use of the amounts of said biomarkers in a sample of a subject exhibiting symptoms of systemic inflammation for assessing systemic inflammation. Moreover, contemplated are a device and a kit for assessing systemic inflammation.

IPC Classes  ?

  • C12Q 1/6883 - Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for diseases caused by alterations of genetic material

50.

LABORATORY DEVICE AND LABORATORY SYSTEM

      
Application Number EP2024074823
Publication Number 2025/051852
Status In Force
Filing Date 2024-09-05
Publication Date 2025-03-13
Owner
  • ROCHE DIAGNOSTICS GMBH (Germany)
  • F. HOFFMANN-LA ROCHE AG (Switzerland)
  • ROCHE DIAGNOSTICS OPERATIONS, INC. (USA)
Inventor Eicher, Patrick

Abstract

The invention relates to a laboratory device (1) for handling laboratory sample container racks (50), the laboratory device (1) comprising a base (2) extending horizontally, the base (2) being adapted to support laboratory sample container racks (50) placed thereon, a first finger (3) being movable relative to the base (2), the first finger (3) being adapted to position a laboratory sample container rack (50) on the base (2), a second finger (4) being adapted to horizontally counteract the first finger (3) so that the laboratory sample container rack (50) positioned on the base (2) is holdable in between the first finger (3) and the second finger (4), a down-holder (5) being movable relative to the base (2), the down-holder (5) being adapted to releasably vertically secure the laboratory sample container rack (50) positioned on the base (2), and a linkage (6) which motion-couples the first finger (3) and the second finger (4) and the down-holder (5) to one another.

IPC Classes  ?

  • G01N 35/00 - Automatic analysis not limited to methods or materials provided for in any single one of groups Handling materials therefor
  • B01L 9/06 - Test-tube standsTest-tube holders
  • B65G 65/00 - Loading or unloading
  • G01N 35/02 - Automatic analysis not limited to methods or materials provided for in any single one of groups Handling materials therefor using a plurality of sample containers moved by a conveyor system past one or more treatment or analysis stations
  • G01N 35/04 - Details of the conveyor system

51.

METHOD FOR CHARACTERIZATION OF A MASS SPECTROMETRY INSTRUMENT COMPRISING AT LEAST ONE MASS ANALYZING CELL

      
Application Number 18719252
Status Pending
Filing Date 2022-12-13
First Publication Date 2025-02-27
Owner Roche Diagnostics Operations, Inc. (USA)
Inventor
  • Quint, Stefan
  • Schweinberger, Florian
  • Tiemann, Benjamin
  • Wagner, Marius

Abstract

A method for characterization of a mass spectrometry instrument (100) comprising at least one mass analyzing cell (102, 104, 106) is proposed. The method comprising the steps of analyzing a sample (110) comprising at least one substance having a known molecular weight by means of the mass spectrometry instrument (100) so as to provide a mass spectrum (116, 118, 144, 146) of the sample (110), determining an outer envelope and an inner envelope of the mass spectrum (116, 118, 144, 146), calculating a squared difference between the outer envelope and the inner envelope, and determining a deviation of the calculated squared difference from a theoretical mass to charge ratio value of the substance.

IPC Classes  ?

  • H01J 49/00 - Particle spectrometers or separator tubes

52.

METHOD FOR OPERATING LABORATORY SYSTEM AND LABORATORY SYSTEM

      
Application Number 18726309
Status Pending
Filing Date 2022-12-20
First Publication Date 2025-02-27
Owner Roche Diagnostics Operations, Inc. (USA)
Inventor
  • Lambaek, Ole
  • Schnarwiler, Dominik
  • Taeymans, Bert

Abstract

A method for operating a laboratory system having a plurality of sample containers; a plurality of laboratory devices to handle the sample containers, the sample containers being assigned for handling to the target device; and a control device configured to control assignment of the sample containers to the target devices; and assigning the sample containers. The assigning comprises: determining a target device workload state for each target device, the workload state being between a first range limit and a second range limit, and determined according to a metric being proportional to a resource target device state indicative of sample containers assigned to the target device, and a power of an output flow of the target device, assigning the sample containers to the target devices according to the target device workload states; and providing sample containers to the plurality of target devices. Furthermore, a laboratory system is provided.

IPC Classes  ?

  • G16H 10/40 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis
  • G06Q 10/0631 - Resource planning, allocation, distributing or scheduling for enterprises or organisations
  • G06Q 10/0639 - Performance analysis of employeesPerformance analysis of enterprise or organisation operations

53.

METHOD FOR OPERATING A SORTER DEVICE IN AN IVD LABORATORY SYSTEM AND IVD LABORATORY SYSTEM

      
Application Number 18941549
Status Pending
Filing Date 2024-11-08
First Publication Date 2025-02-27
Owner Roche Diagnostics Operations, Inc. (USA)
Inventor
  • Lambaek, Ole
  • Schesny, Andreas

Abstract

The present disclosure refers to a method for operating a sorter device in an IVD laboratory system, the method comprising providing a sorter device in an IVD laboratory system provided with a system operation controller, the sorter device having a plurality of sample container racks each provided with reception holes for receiving sample containers, a handling device configured to pick sample containers from and place sample containers in the reception holes of the sample container racks, a sorter device controller configured to control operation of the sorter device and connectable to the system operation controller, and an output device functionally connected to the sorter device controller and configured to output at least one of audio data and video data. The sorter device is configured in a pre-operation process, the configuring comprising: assigning the plurality of sample container racks to a plurality of processing sub-targets conducted by the IVD laboratory system in operation, wherein a first sample container rack is assigned to a first processing sub-target and a second sample container rack is assigned to a second processing sub-target which is different from the first processing sub-target, and assigning to the first sample container rack a first threshold value indicative of a first threshold number of sample containers in the first sample container rack, wherein the first threshold number of sample containers is smaller than a maximum number of sample containers receivable in the first sample container rack. The sorter device is operated in an operation process, the operating comprising: placing sample containers in the reception holes of the first sample container rack by the handling device, determining a first present number of sample containers received in the first sample container rack by the sorter device controller, comparing the first present number of sample containers to the first threshold value by the sorter device controller, and if the first present number of sample containers is equal to or greater than the first threshold value, outputting a first warning data through the output device. Furthermore, an IVD laboratory system is provided.

IPC Classes  ?

  • G01N 35/00 - Automatic analysis not limited to methods or materials provided for in any single one of groups Handling materials therefor
  • G01N 35/04 - Details of the conveyor system

54.

Sensor for detecting a plurality of analytes

      
Application Number EP2024073193
Publication Number 2025/040616
Status In Force
Filing Date 2024-08-19
Publication Date 2025-02-27
Owner
  • ROCHE DIAGNOSTICS GMBH (Germany)
  • F. HOFFMANN-LA ROCHE AG (Switzerland)
  • ROCHE DIAGNOSTICS OPERATIONS, INC. (USA)
Inventor
  • Amann-Zalan, Ildiko
  • Gutiérrez-Sanz, Oscar
  • Lopez-Calle, Eloisa
  • Probst, Christopher
  • Wagner, Robin

Abstract

There is disclosed a method and sensor for detecting a plurality of analytes in bodily fluid, the sensor comprising electrodes including a first working electrode, a second working electrode, a third working electrode, a counter electrode, and a reference electrode; wherein the first working electrode is configured to detect a first signal indicative of a first analyte concentration using potentiometry; wherein the second working electrode is configured to detect a second signal indicative of a second analyte concentration using amperometry; wherein the third working electrode is configured to detect a third signal indicative of a third analyte concentration using amperometry; wherein the first analyte, the second analyte, and third analyte are different analytes; wherein the first signal, the second signal, and the third signal are detected using the same reference electrode; wherein at least part of the detection of the first signal occurs simultaneously with the detection of the second signal; wherein the second signal and third signal are detected using the same counter electrode; wherein at least part of the detection of the second signal occurs simultaneously with the detection of the third signal; and wherein at least one of the second working electrode and third working electrode is continuously polarized by application of a polarization voltage during detection of the first signal, second signal and third signal.

IPC Classes  ?

  • A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value
  • A61B 5/1468 - Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value using chemical or electrochemical methods, e.g. by polarographic means
  • G01N 27/27 - Association of two or more measuring systems or cells, each measuring a different parameter, where the measurement results may be either used independently, the systems or cells being physically associated, or combined to produce a value for a further parameter
  • G01N 33/49 - Physical analysis of biological material of liquid biological material blood
  • G01N 33/70 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing involving creatine or creatinine
  • G01N 33/487 - Physical analysis of biological material of liquid biological material
  • A61B 5/1495 - Calibrating or testing in vivo probes
  • G01N 33/62 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing involving urea
  • G01N 33/64 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing involving ketones
  • G01N 33/98 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing involving alcohol, e.g. ethanol in breath

55.

METHOD FOR PREPARING ACID RESISTANT MAGNETIC PARTICLES AND ACID RESISTANT MAGNETIC PARTICLES

      
Application Number 18713584
Status Pending
Filing Date 2022-11-23
First Publication Date 2025-02-27
Owner Roche Diagnostics Operations, Inc. (USA)
Inventor
  • Silvestre, Martin Eduardo
  • Eisold, Sabine
  • Heindl, Dieter
  • Peters, Kristina

Abstract

In a first aspect, the invention relates to a method for preparing a magnetic bead comprising at least one magnetic particle (M) and a silica coating, wherein the silica coating comprises at least two silica layers, the method comprising steps (a) to (d), wherein at least one of steps (b), (c) and (d) is/are done under sonication, wherein sonication is done with an amplitude (peak-to-peak) in the range of from 50 to 250 μm. A second aspect of the invention is related to a magnetic bead comprising (i) at least one magnetic particle (M) and (ii) a silica coating, wherein the silica coating comprises at least two silica layers; wherein the magnetic bead is stable against 7.5 M hydrochlorid acid and has a metal (cation) leaching rate in 7.5 M hydrochloric acid in the range of from 0.1 to 10%, wherein the metal (cation) leaching is determined according to a complex formation of Fe2+ with bathophenanthroline according to Reference Example 8.2. In a third aspect, the invention relates to a functionalized magnetic bead comprising at least one, magnetic bead according to the second aspect, wherein an outer silica layer is functionalized with at least one group selected from the group consisting of amino group, azide group, alkyne group, carboxyl group, thiol group, epoxy group, aryl group and alkyl group. A fourth aspect of the invention is directed to a process for functionalizing a magnetic bead according to the second aspect comprising at least one magnetic particle (M) and a silica coating, wherein the silica coating comprises at least two silica layers. A fifth aspect of the invention is related to a method for preparing magnetic Fe3O4 supra particles and a sixth aspect relates to the use of a magnetic bead according to the second aspect or of a functionalized according to the fourth aspect for immobilization of acid stable biocatalysts or for solid-phase organic synthesis using acid-stable linker.

IPC Classes  ?

  • H01F 1/33 - Magnets or magnetic bodies characterised by the magnetic materials thereforSelection of materials for their magnetic properties of inorganic materials characterised by their coercivity of soft-magnetic materials mixtures of metallic and non-metallic particlesMagnets or magnetic bodies characterised by the magnetic materials thereforSelection of materials for their magnetic properties of inorganic materials characterised by their coercivity of soft-magnetic materials metallic particles having oxide skin
  • H01F 1/00 - Magnets or magnetic bodies characterised by the magnetic materials thereforSelection of materials for their magnetic properties
  • H01F 1/34 - Magnets or magnetic bodies characterised by the magnetic materials thereforSelection of materials for their magnetic properties of inorganic materials characterised by their coercivity of soft-magnetic materials non-metallic substances, e.g. ferrites

56.

METHOD OF CONTROLLING THE FUNCTIONALITY OF AN ANALYTICAL SYSTEM

      
Application Number EP2024073252
Publication Number 2025/040642
Status In Force
Filing Date 2024-08-20
Publication Date 2025-02-27
Owner
  • ROCHE DIAGNOSTICS GMBH (Germany)
  • ROCHE DIAGNOSTICS OPERATIONS, INC. (USA)
  • F. HOFFMANN-LA ROCHE AG (Switzerland)
Inventor Juergens, Ludger Herbert Joachim

Abstract

A method of controlling the functionality of an analytical system (110) is disclosed. The method comprises: a. providing at least one container (114) containing at least one control fluid, the container (114) comprising at least one identifier (124), wherein the identifier (124) comprises at least one identification number of the container (114); b. reading the identifier (124) of the container (114) by using at least one reading device (113) of the analytical system (110); and c. performing a database query in a database (116) of the analytical system (110), the database (116) containing database entries (130) for a plurality of known containers (114) comprising identification numbers of the known containers (114) and assigned expiry information for the respective known containers (114), the database query comprising checking if the container (114) already has a database entry (130) in the data- base (116). Further, an analytical system (110) comprising at least one analytical device (112) for determining an analyte concentration in a sample of a bodily fluid is disclosed.

IPC Classes  ?

  • G16H 10/40 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis
  • G16H 40/40 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
  • G16H 50/20 - ICT specially adapted for medical diagnosis, medical simulation or medical data miningICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems
  • G01N 33/49 - Physical analysis of biological material of liquid biological material blood
  • G01N 35/00 - Automatic analysis not limited to methods or materials provided for in any single one of groups Handling materials therefor
  • A61B 5/00 - Measuring for diagnostic purposes Identification of persons

57.

ELECTROCHEMICAL IMMUNOASSAY

      
Application Number EP2024073570
Publication Number 2025/040753
Status In Force
Filing Date 2024-08-22
Publication Date 2025-02-27
Owner
  • ROCHE DIAGNOSTICS GMBH (Germany)
  • F. HOFFMANN-LA ROCHE AG (Switzerland)
  • ROCHE DIAGNOSTICS OPERATIONS, INC. (USA)
Inventor
  • Gutierrez-Sanz, Oscar
  • Lopez-Calle, Eloisa
  • Osterheld, Hanna
  • Thakur, Bhawana
  • Treu, Tabea

Abstract

There is disclosed an electrode for an electrochemical immunoassay; wherein the electrode is functionalized with at least one antibody or fragment thereof configured to bind to at least one analyte; and wherein the at least one antibody or fragment thereof is conjugated with at least one redox species such that the electrochemical activity of the at least one redox species is altered when the at least one antibody or fragment thereof binds to the at least one analyte.

IPC Classes  ?

  • G01N 33/543 - ImmunoassayBiospecific binding assayMaterials therefor with an insoluble carrier for immobilising immunochemicals

58.

MONITORING OF CARDIOVASCULAR MARKERS IN INTERSTITIAL FLUID AND ITS APPLICATION IN ASSESSMENT OF HEART FAILURE

      
Application Number EP2024073571
Publication Number 2025/040754
Status In Force
Filing Date 2024-08-22
Publication Date 2025-02-27
Owner
  • ROCHE DIAGNOSTICS GMBH (Germany)
  • F. HOFFMANN-LA ROCHE AG (Switzerland)
  • ROCHE DIAGNOSTICS OPERATIONS, INC. (USA)
Inventor
  • Gutierrez-Sanz, Oscar
  • Lopez-Calle, Eloisa
  • Amann-Zalan, Ildiko

Abstract

The present invention relates to methods of assessing heart failure (HF), determining the risk of developing HF, monitoring HF, classifying HF, risk stratification and prognosis in patients with HF and determining the therapeutic effect of a treatment regimen for HF in a subject by determining the level of one or more cardiac related (poly)peptide biomarkers in the interstitial fluid (ISF) from the subject, and comparing the determined level to a reference value. Further this invention refers to the use of ISF in the methods described herein.

IPC Classes  ?

  • G01N 33/68 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing involving proteins, peptides or amino acids

59.

METHOD AND LABORATORY SYSTEM FOR DETERMINING AT LEAST ONE CONTAINER INFORMATION ABOUT A LABORATORY SAMPLE CONTAINER

      
Application Number 18935834
Status Pending
Filing Date 2024-11-04
First Publication Date 2025-02-20
Owner Roche Diagnostics Operations, Inc. (USA)
Inventor
  • Rein, Michael
  • Wiegand, Friederike

Abstract

A method is provided for determining at least one container information (coi) about a laboratory sample container, wherein the method comprises the steps: a) acquiring an image (ibc) comprising a brightness and/or color information (bci) of a possible region of the container, b) acquiring a map (md) comprising a depth information (di) of the region, and c) determining the container information (coi) by fusing the brightness and/or color information (bci) and the depth information (di).

IPC Classes  ?

  • B01L 3/00 - Containers or dishes for laboratory use, e.g. laboratory glasswareDroppers
  • G06V 10/80 - Fusion, i.e. combining data from various sources at the sensor level, preprocessing level, feature extraction level or classification level
  • G06V 20/64 - Three-dimensional objects

60.

POSITION TRACKING SYSTEM AND METHOD FOR TRACKING A RELATIVE POSITION OF CONNECTED MODULES

      
Application Number 18937855
Status Pending
Filing Date 2024-11-05
First Publication Date 2025-02-20
Owner Roche Diagnostics Operations, Inc. (USA)
Inventor
  • Leontjevs, Vladimirs
  • Riedel, Philipp

Abstract

A position tracking system for tracking a relative position between connected modules. A target is arrangeable on and/or within a first connected module, the connected modules mechanically interacting for transporting objects between modules; a position sensor is arrangeable on and/or within a second connected module and is configured for generating a sensor signal according to a relative position between the position sensor and target, a processing unit configured for tracking a relative position between the connected modules from the sensor signal; and a second sensor is configured for generating a second sensor signal according to at least a second parameter, wherein the second sensor is a temperature sensor and/or a humidity sensor, the processing unit being configured for considering the second sensor signal when determining the relative position between the connected modules. Further disclosed are related monitoring systems and methods for tracking and monitoring at least two connected modules.

IPC Classes  ?

  • G01N 35/00 - Automatic analysis not limited to methods or materials provided for in any single one of groups Handling materials therefor

61.

METHOD OF HANDLING LABORATORY SAMPLE CONTAINERS AND APPARATUS FOR HANDLING LABORATORY SAMPLE CONTAINERS

      
Application Number 18927356
Status Pending
Filing Date 2024-10-25
First Publication Date 2025-02-13
Owner Roche Diagnostics Opereations, Inc. (USA)
Inventor
  • Baltasar Badaya, Raul
  • Baumgart, Julian

Abstract

A method of handling laboratory sample containers is presented. The method comprises moving a laboratory sample container to a target position. The target position is a position at which the laboratory sample container is inserted into a corresponding orifice of a laboratory sample container rack provided that the laboratory sample container rack is placed at an intended position. The laboratory sample container is prevented from moving horizontally more than a predetermined horizontal distance if inserted into the corresponding orifice of the laboratory sample container rack. The method also comprises applying a force in a horizontal direction (xy) to the laboratory sample container, determining if the laboratory sample container moves in the horizontal direction (xy) more than the predetermined horizontal distance, and performing an error procedure if it is determined that the laboratory sample container moves in the horizontal direction (xy) more than the predetermined horizontal distance.

IPC Classes  ?

  • G01N 35/00 - Automatic analysis not limited to methods or materials provided for in any single one of groups Handling materials therefor
  • G01N 35/02 - Automatic analysis not limited to methods or materials provided for in any single one of groups Handling materials therefor using a plurality of sample containers moved by a conveyor system past one or more treatment or analysis stations
  • G01N 35/04 - Details of the conveyor system

62.

NOVEL ANTI-THYMIDINE KINASE ANTIBODIES

      
Application Number 18772484
Status Pending
Filing Date 2024-07-15
First Publication Date 2025-02-06
Owner Roche Diagnostics Operations, Inc. (USA)
Inventor
  • Duefel, Hartmut
  • Engel, Alfred
  • Kroner, Frank
  • Meier, Thomas
  • Rutz, Sandra
  • Schraeml, Michael
  • Tabares, Gloria
  • Kurtkaya, Ulrike
  • Pinchuk, Boris
  • Zimmermann, Christina

Abstract

The present invention relates to a novel monoclonal antibody that specifically binds to a conformation dependent epitope on human thymidine kinase 1 (hTK-1; SEQ ID NO:1), to methods for quantifying hTK-1 employing the antibody and to the use of the anti-hTK-1 antibody in quantifying hTK-1

IPC Classes  ?

  • C07K 16/40 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against enzymes
  • G01N 33/543 - ImmunoassayBiospecific binding assayMaterials therefor with an insoluble carrier for immobilising immunochemicals

63.

SERUM EPHA1 AS BIOMARKER FOR ENDOMETRIOSIS

      
Application Number EP2024071268
Publication Number 2025/026908
Status In Force
Filing Date 2024-07-26
Publication Date 2025-02-06
Owner
  • ROCHE DIAGNOSTICS GMBH (Germany)
  • F. HOFFMANN-LA ROCHE AG (Switzerland)
  • ROCHE DIAGNOSTICS OPERATIONS, INC. (USA)
Inventor
  • Allegranza, Deirdre Mary
  • Flohr, Aljoscha Michael
  • Hund, Martin
  • Klammer, Martin

Abstract

The present invention relates to methods of diagnosing whether a subject has endometriosis, uterine/pelvic pathology and/or endometriosis and/or uterine/pelvic pathology associated neuropathic pain, to methods of determining the therapeutic effect of a treatment regimen for endometriosis, uterine/pelvic pathology and/or endometriosis and/or uterine/pelvic pathology associated neuropathic pain, and methods of monitoring endometriosis, uterine/pelvic pathology and/or endometriosis and/or uterine/pelvic pathology associated neuropathic pain progression in a subject, by determining the amount or concentration of EphA1 in a sample of the subject, and comparing the determined level to a reference value.

IPC Classes  ?

  • G01N 33/574 - ImmunoassayBiospecific binding assayMaterials therefor for cancer
  • G01N 33/68 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing involving proteins, peptides or amino acids
  • G16H 50/20 - ICT specially adapted for medical diagnosis, medical simulation or medical data miningICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems

64.

MONOCLONAL ANTIBODIES SPECIFIC FOR SARS-COV-2 RBD

      
Application Number 18704654
Status Pending
Filing Date 2022-10-25
First Publication Date 2025-02-06
Owner Roche Diagnostics Operations, Inc. (USA)
Inventor
  • Gerg, Michael
  • Jochum, Simon
  • Jucknischke, Ute
  • Kurtkaya, Ulrike
  • Schraeml, Michael
  • Stiegler, Sandrine Carolina

Abstract

The present invention relates to monoclonal antibodies binding to the Receptor Binding Domain of the Spike protein of SARS-CoV-2 virus, nucleic acids encoding said antibody, host cells producing the same, compositions and kits comprising said antibodies, method of detecting SARS-CoV-2 virus in a sample comprising using said antibodies and methods of using said antibodies in immunoassays.

IPC Classes  ?

  • C07K 16/10 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from viruses from RNA viruses

65.

BLAST CELL CLASSIFICATION

      
Application Number 18723851
Status Pending
Filing Date 2022-12-23
First Publication Date 2025-02-06
Owner Roche Diagnostics Operations, Inc. (USA)
Inventor
  • Bruenggel, Nils
  • Conway, Patrick
  • Davidson, Simon John
  • Dejean, Emilie
  • Gildenblat, Jacob
  • Sagiv, Chen
  • Vallotton, Pascal

Abstract

A computer-implemented method of differentiating between lymphoid blast cells and myeloid blast cells comprises: receiving a digital image containing one or more blast cells; applying a parametric model classifier to one or more portions of the digital image each containing a respective blast cell, the parametric model configured to generate an output indicative of whether each blast cell is a lymphoid blast cell or a myeloid blast cell. Computer-implemented methods of training a parametric model are also provided, as well as a clinical decision support system relying on the computer-implemented method of classifying blast cells.

IPC Classes  ?

  • G16H 50/20 - ICT specially adapted for medical diagnosis, medical simulation or medical data miningICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems
  • G16H 30/40 - ICT specially adapted for the handling or processing of medical images for processing medical images, e.g. editing
  • G16H 50/70 - ICT specially adapted for medical diagnosis, medical simulation or medical data miningICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for mining of medical data, e.g. analysing previous cases of other patients

66.

FEDERATED LEARNING OF MEDICAL VALIDATION MODEL

      
Application Number 18696634
Status Pending
Filing Date 2021-11-01
First Publication Date 2025-01-30
Owner Roche Diagnostics Operations, Inc. (USA)
Inventor
  • Yao, Yi
  • Xing, Wei Bin
  • Tao, Xiao Jun
  • Qian, Jing
  • Zhou, Qi
  • Zhang, Chenxi
  • Qian, Yin

Abstract

A computer-implemented method is provided that includes transmitting, by a master node to a plurality of computing nodes, definition information about an initial medical validation model (410): performing, by the master node, a federated learning process together with the plurality of computing nodes (420), to jointly train the initial medical validation model using respective processed local training datasets available at the plurality of computing nodes, the respective local training datasets being processed by the plurality of computing nodes based on the definition information; and determining, by the master node, a final medical validation model based on a result of the federated learning process (430). Through the solution, by means of federated learning, it addresses the data security and privacy concerns from local sites owning.

IPC Classes  ?

  • G16H 50/20 - ICT specially adapted for medical diagnosis, medical simulation or medical data miningICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems
  • G16H 10/40 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis
  • G16H 15/00 - ICT specially adapted for medical reports, e.g. generation or transmission thereof
  • H04W 84/02 - Hierarchically pre-organised networks, e.g. paging networks, cellular networks, WLAN [Wireless Local Area Network] or WLL [Wireless Local Loop]

67.

MR-PROADM MARKER PANELS FOR EARLY DETECTION OF SEPSIS

      
Application Number 18696730
Status Pending
Filing Date 2022-09-28
First Publication Date 2025-01-30
Owner Roche Diagnostics Operations, Inc. (USA)
Inventor
  • Gruenewald, Felix
  • Jeger, Victor Johann Raul
  • Klammer, Martin
  • Schuetz, Philipp
  • Von Holtey, Maria
  • Weber, Stephen
  • Wegmeyer, Heike
  • Wienhues-Thelen, Ursula-Henrike

Abstract

The present invention concerns the field of diagnostics. Specifically, it relates to a method for assessing a subject with suspected infection comprising the steps of determining the amount of a first biomarker in a sample of the subject, said first biomarker being MR-proADM, determining the amount of a second biomarker in a sample of the subject, wherein said second biomarker is selected from the group consisting of: sFlt-1, GDF15 and ESM1, comparing the amounts of the biomarkers to references for said biomarkers and/or calculating a score for assessing the subject with suspected infection based on the amounts of the biomarkers, and assessing said subject based on the comparison and/or the calculation. The invention also relates to the use of a first biomarker being MR-proADM and a second biomarker selected from the group consisting of: sFlt-1, GDF15 and ESM1, or a detection agent specifically binding to said first biomarker and a detection agent specifically binding to said second biomarker for assessing a subject with suspected infection. Moreover, the invention further relates to a computer-implemented method for assessing a subject with suspected infection and a device and a kit for assessing a subject with suspected infection.

IPC Classes  ?

  • G01N 33/573 - ImmunoassayBiospecific binding assayMaterials therefor for enzymes or isoenzymes
  • G01N 33/68 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing involving proteins, peptides or amino acids

68.

SINGLE-USE DISPENSER, DISPENSER-ARRANGEMENT, USE OF A BLOW-MOLDED VESSEL, AND USE OF A SINGLE-USE DISPENSER

      
Application Number EP2024070428
Publication Number 2025/021649
Status In Force
Filing Date 2024-07-18
Publication Date 2025-01-30
Owner
  • ROCHE DIAGNOSTICS GMBH (Germany)
  • F. HOFFMANN-LA ROCHE AG (Switzerland)
  • ROCHE DIAGNOSTICS OPERATIONS, INC. (USA)
Inventor Jürgens, Ludger Herbert Joachim

Abstract

The invention relates to a single-use dispenser (1) for supplying a control liquid (L) to an analytical device, the single-use dispenser (1) comprising a blow-molded vessel (2) fluid-tightly delimiting an interior volume (3), and a volume (4) of the control liquid (L), wherein the volume (4) of the control liquid (L) is stored within the interior volume (3), and wherein the blow-molded vessel (2) has a predetermined breaking point (5) adapted to form an outlet aperture (8) for the control liquid (L) by breaking the blow-molded vessel (2) in its predetermined breaking point (5).

IPC Classes  ?

  • B01L 3/00 - Containers or dishes for laboratory use, e.g. laboratory glasswareDroppers
  • A61J 1/06 - Ampoules or cartridges
  • B65D 1/09 - Ampoules

69.

SCREENING METHODS FOR ANTIBODY COMPOSITIONS

      
Application Number EP2024070419
Publication Number 2025/017135
Status In Force
Filing Date 2024-07-18
Publication Date 2025-01-23
Owner
  • F. HOFFMANN-LA ROCHE AG (Switzerland)
  • ROCHE DIAGNOSTICS GMBH (Germany)
  • ROCHE DIAGNOSTICS OPERATIONS, INC. (USA)
Inventor
  • Ofenloch-Haehnle, Beatus
  • Jochum, Simon

Abstract

The present invention provides a screening method for obtaining an antibody composition comprising at least two different monoclonal antibodies. The invention also relates to said antibody composition, and its use. Further, the invention provides a kit comprising said antibody composition. The invention also provides a method for determining a level of antibodies directed to an antigen in a sample.

IPC Classes  ?

  • G01N 33/68 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing involving proteins, peptides or amino acids
  • G01N 33/569 - ImmunoassayBiospecific binding assayMaterials therefor for microorganisms, e.g. protozoa, bacteria, viruses
  • G01N 33/96 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing involving blood or serum control standard

70.

METHODS FOR DETERMINING MS REAGENT PARAMETERS VIA LEACHABLE COMPOUNDS

      
Application Number EP2024070440
Publication Number 2025/017144
Status In Force
Filing Date 2024-07-18
Publication Date 2025-01-23
Owner
  • ROCHE DIAGNOSTICS GMBH (Germany)
  • F. HOFFMANN-LA ROCHE AG (Switzerland)
  • ROCHE DIAGNOSTICS OPERATIONS, INC. (USA)
Inventor Schweinberger, Florian Frank

Abstract

The present invention relates to a method for determining a mass spectrometry (MS) reagent stored in a storage container for a period of time and/or at least one storage parameter thereof, said method comprising (a) determining at least one leachable compound of said storage container; (b) comparing the at least one leachable compound determined in step (a) to a reference, and (c) determining said MS reagent and/or at least one storage parameter thereof based on the comparing in step (b); The present invention also relates to a method of quality assurance of an MS analysis, to a data carrier, an MS system, and a kit related thereto.

IPC Classes  ?

71.

AUTOMATIC ANALYZER

      
Application Number 18711999
Status Pending
Filing Date 2022-11-14
First Publication Date 2025-01-23
Owner
  • HITACHI HIGH-TECH CORPORATION (Japan)
  • ROCHE DIAGNOSTICS OPERATIONS, INC. (USA)
Inventor
  • Hamasaki, Koshin
  • Takada, Eiichiro
  • Saito, Yoshiaki
  • Kobel, Stefan
  • Haberhausen, Gerd
  • Voelker, Markus
  • Foster, Elisabeth

Abstract

An automatic analyzer 101 includes a judgment part 118f which descends a probe 201 in the direction of a reagent 205 and suspends the downward movement of the probe 201 at a first position PT higher than a liquid level value P0 assumed to be a height of a liquid level by a first predetermined value Db. The judgment part 118f determines that the reagent 205 is in a normal state when the liquid level is not detected by an electrostatic capacity sensor 206 at the first position PT. Further, the judgment part 118f determines that the reagent 205 in an abnormal state when the liquid level is detected by the electrostatic capacity sensor 206 before reaching the first position PT. An automatic analyzer capable of reducing consumption of consumables produced at the time of reagent registration compared with conventional cases is provided.

IPC Classes  ?

  • G01N 35/10 - Devices for transferring samples to, in, or from, the analysis apparatus, e.g. suction devices, injection devices

72.

DSFV AS AN IGG FRAGMENT FORMAT AND METHODS OF PRODUCTION AND LABELLING THEREOF

      
Application Number EP2024070463
Publication Number 2025/017153
Status In Force
Filing Date 2024-07-18
Publication Date 2025-01-23
Owner
  • F. HOFFMANN-LA ROCHE AG (Switzerland)
  • ROCHE DIAGNOSTICS GMBH (Germany)
  • ROCHE DIAGNOSTICS OPERATIONS, INC. (USA)
Inventor
  • Bartl, Andrea
  • Hemann, Matthias
  • Kunzelmann, Stefan
  • Meier, Thomas
  • Mohamed, Mohamed Yosry Hassan
  • Oelschlaegel, Tobias
  • Roesser, Alisa
  • Schraeml, Michael
  • Sieber, Laura

Abstract

The present invention relates to antibodies and antigen-binding fragments thereof, in particular (ds)Fv fragments. The invention also relates to methods of producing these antibodies and fragments thereof as well as their uses and corresponding polynucleotides and kits comprising the same.

IPC Classes  ?

  • C07K 16/18 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans
  • C07K 16/26 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against hormones

73.

RATIOS OF sFlt-1 TO P1GF OR ENDOGLIN TO P1GF AS BIOMARKERS FOR PREECLAMPSIA RELATED ADVERSE OUTCOMES AFTER BIRTH

      
Application Number 18902725
Status Pending
Filing Date 2024-09-30
First Publication Date 2025-01-16
Owner Roche Diagnostics Operations, Inc. (USA)
Inventor
  • Hund, Martin
  • Dieterle, Thomas
  • Lapaire, Olav

Abstract

The present invention is directed to a method for predicting the risk of a female subject to develop postpartum HELLP syndrome, postpartum preeclampsia, or postpartum eclampsia. The method is based on the determination of the levels of i) sFlt-1 and PlGF, or ii) Endoglin and PlGF in a first sample obtained from said subject before delivery of baby, and a second sample of from said subject obtained after delivery of baby. Moreover, encompassed by the invention are devices and kits for carrying out the method of the present invention.

IPC Classes  ?

  • G01N 33/68 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing involving proteins, peptides or amino acids

74.

Carry case for handheld medical meter

      
Application Number 29841718
Grant Number D1057393
Status In Force
Filing Date 2022-06-08
First Publication Date 2025-01-14
Grant Date 2025-01-14
Owner Roche Diagnostics Operations, Inc. (USA)
Inventor
  • Arnold, Peter
  • Frontzek, Carolin
  • Galbraith, Sofia Elisabeth
  • Gebhard, Roman

75.

METHOD FOR DETERMINING LIFETIME OF AT LEAST ONE CHROMATOGRAPHY COLUMN

      
Application Number 18294945
Status Pending
Filing Date 2022-08-01
First Publication Date 2025-01-02
Owner ROCHE DIAGNOSTICS OPERATIONS, INC. (USA)
Inventor
  • Laubender, Ruediger
  • Quint, Stefan
  • Wagner, Marius

Abstract

A computer implemented method (140) for determining lifetime of at least one chromatography column (116) of at least one chromatography device (110), wherein the method (140) comprises the following steps: i) receiving model input chromatography data via at least one communication interface (128); ii) determining at least one state variable indicative of lifetime of the chromatography column (116) using at least one data driven model based on the model input chromatography data using at least one processing device (130); iii) evaluating the determined state variable thereby determining information about lifetime by using the processing device (130), wherein the evaluation comprises comparing the determined state variable to at least one threshold. A computer implemented method (140) for determining lifetime of at least one chromatography column (116) of at least one chromatography device (110), wherein the method (140) comprises the following steps: i) receiving model input chromatography data via at least one communication interface (128); ii) determining at least one state variable indicative of lifetime of the chromatography column (116) using at least one data driven model based on the model input chromatography data using at least one processing device (130); iii) evaluating the determined state variable thereby determining information about lifetime by using the processing device (130), wherein the evaluation comprises comparing the determined state variable to at least one threshold. Further, a test system (112), a computer program and a method for operating a chromatography column (116) are disclosed.

IPC Classes  ?

76.

DETECTION OF AIR BUBBLES IN OPTICAL DETECTION UNIT

      
Application Number 18755464
Status Pending
Filing Date 2024-06-26
First Publication Date 2024-12-26
Owner Roche Diagnostics Operations, Inc. (USA)
Inventor
  • Hildenbrand, Juergen
  • Kramlich, Alexander
  • Lambertson, Michael

Abstract

An in-vitro diagnostic (IVD) analyzer 200 comprising an optical detection unit 217 comprising a cuvette 214 for the optical measurement of a biological sample 2, 2′ is herein disclosed. The IVD analyzer 200 further comprises a piezo actuator 218 arranged on one side of the cuvette 214 configured to transmit ultrasonic waves 254, 254′ through the cuvette 214, a piezo receiver 218′ arranged on the opposite side of the cuvette 214 configured to receive ultrasonic waves 255, 255′, 255″ transmitted through the cuvette 214 and a controller 250 configured to operate according to either a lysis operating mode (L) or an air-detection operating mode (AD). According to the lysis operating mode (L) the piezo actuator 218 is configured to transmit ultrasonic waves 254′ through the cuvette 214 for disrupting cellular particles contained in the biological sample 2. According to the air-detection operating mode (AD) the piezo actuator 218 is configured to transmit ultrasonic waves 254 through the cuvette 214 and the controller 250 is configured to correlate changes in amplitude and/or shifts of phase of the ultrasonic waves 255, 255′, 255″ received by the piezo receiver 218′ relative to reference values with an eventual presence and quantity of air 3 in the cuvette 214, in order to determine if the optical measurement of the biological sample 2, 2′ is affected by the presence of air 3. A respective automated method of operating the in-vitro diagnostic analyzer 200 in order to determine if the optical measurement of the biological sample 2, 2′ is affected by the presence of air is herein also disclosed.

IPC Classes  ?

  • G01N 21/94 - Investigating contamination, e.g. dust

77.

METHOD FOR IMPROVING CROSS-FLOW FILTRATION AND CROSS-FLOW FILTRATION SYSTEM

      
Application Number 18810797
Status Pending
Filing Date 2024-08-21
First Publication Date 2024-12-12
Owner Roche Diagnostics Operations, Inc. (USA)
Inventor
  • Munoz, Carlos
  • Zahn, Hans

Abstract

A method of cross-flow filtering wastewater from a diagnostic apparatus or a laboratory analyser, wherein the wastewater comprises nanoparticles and/or microparticles, and the wastewater is streaming in a laminar flow across a surface of a filter membrane, the method comprising: (a) streaming the wastewater across the surface of the filter membrane with a flow rate, so that the flow of the wastewater is a laminar flow with a Reynolds number (Re) of smaller than 500; (b) streaming the wastewater in pulse cycles across the surface of the filter membrane, wherein each pulse cycle comprises one active phase in which the wastewater is under a duty pressure and one inactive phase in which the wastewater is under an inactive pressure, wherein the inactive pressure is no more than 10% of the duty pressure and the active phases have a duration of greater than 50% of the corresponding pulse cycles; and (c) separating the nanoparticles and/or microparticles from the wastewater when the wastewater passes through the filter membrane. Also described is a cross-flow filtration system configured for performing the method.

IPC Classes  ?

  • C02F 1/00 - Treatment of water, waste water, or sewage
  • C02F 103/00 - Nature of the water, waste water, sewage or sludge to be treated

78.

HEALTHCARE DATA SYSTEM

      
Application Number 18421536
Status Pending
Filing Date 2024-01-24
First Publication Date 2024-12-05
Owner Roche Diagnostics Operations, Inc. (USA)
Inventor De Luca, Domenico

Abstract

A healthcare data system. The system comprises a data protection entity configured to: sign at least a portion of a routing header of a data packet with a private key held by the data protection entity, the data packet including a payload and a routing header, the payload including healthcare data and the routing header indicating an intended consumer of the data packet; and transmit the data packet on towards the intended consumer. The healthcare data system further comprises one or more data receivers, each configured to: receive the data packet; and verify the signed routing header.

IPC Classes  ?

79.

NOVEL MONOCLONAL ANTIBODIES DIRECTED AGAINST L-THYROXINE AND DIAGNOSTIC USES THEREOF

      
Application Number 18662694
Status Pending
Filing Date 2024-05-13
First Publication Date 2024-12-05
Owner Roche Diagnostics Operations, Inc. (USA)
Inventor
  • Gerg, Michael
  • Hirzel, Klaus
  • Hojer, Caroline Dorothea
  • Josel, Hans-Peter
  • Jucknischke, Ute
  • Lehmann, Holger
  • Markina, Anastasia
  • Prencipe, Giuseppe
  • Von Proff, Leopold
  • Schraeml, Michael
  • Halldórsson, Steinar

Abstract

The present invention provides a novel monoclonal antibody specifically binding to L-Thyroxine (T4) and compositions and kits comprising such antibodies. Furthermore, provided are polynucleotides encoding such monoclonal antibodies, host cells expressing said antibodies, methods of producing such antibodies and diagnostic methods using such monoclonal antibodies. The monoclonal antibody of the invention comprises a heavy chain variable domain (VH) comprising V or A in position 33; Y in position 50; W in position 52; I in position 98, G, A or V in position 99; Y in position 100; and I in position 100b; and a light chain variable domain (VL) comprising amino acids H or Y in position 28; N or K in position 29; W in position 32; G or A in position 91; Y, W or F in position 92; S or T in position 93; Y or F in position 95b; N, S, T or Q in position 95c; and H in position 96, wherein the positions of the amino acids in the VH and the VL are indicated according to the Kabat numbering scheme, respectively.

IPC Classes  ?

  • C07K 16/26 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against hormones
  • G01N 33/78 - Thyroid gland hormones

80.

Carry case for handheld medical meter

      
Application Number 29841723
Grant Number D1052269
Status In Force
Filing Date 2022-06-08
First Publication Date 2024-11-26
Grant Date 2024-11-26
Owner Roche Diagnostics Operations, Inc. (USA)
Inventor
  • Arnold, Peter
  • Frontzek, Carolin
  • Galbraith, Sofia Elisabeth
  • Gebhard, Roman

81.

OPTICAL SYSTEM FOR FOURIER PTYCHOGRAPHY

      
Application Number 18667208
Status Pending
Filing Date 2024-05-17
First Publication Date 2024-11-21
Owner Roche Diagnostics Operations, Inc. (USA)
Inventor Salzmann, Wenzel

Abstract

An optical system configured for Fourier Ptychography is disclosed, comprising at least one array of light emitters, wherein each light emitter is configured for emitting at least one illumination light beam towards a sample plane; at least one lenslet array comprising a plurality of lenses, wherein each of the lenses is dedicated to at least one of the light emitters of the array of light emitters, wherein orientation and shape of the respective lens is adapted to the dedicated light emitter, wherein the lenslet array is configured for focusing the illumination light beams in the sample plane. The array of light emitters and the lenslet array are arranged such that the sample plane is illuminated by the illumination light beams under different illumination angles.

IPC Classes  ?

  • G02B 21/00 - Microscopes
  • G02B 21/36 - Microscopes arranged for photographic purposes or projection purposes

82.

METHOD FOR AUTOMATED QUALITY CHECK OF CHROMATOGRAPHIC AND/OR MASS SPECTRAL DATA

      
Application Number 18689808
Status Pending
Filing Date 2022-09-05
First Publication Date 2024-11-21
Owner Roche Diagnostics Operations, Inc. (USA)
Inventor
  • Tarasov, Kirill
  • Reichert, Andreas
  • Hummel, Manuela
  • Lang, Robert
  • Wagner, Marius

Abstract

A computer implemented method for automated quality check of chromatographic and/or mass spectral data is disclosed. The method comprises the following steps: a) (110) providing processed chromatographic and/or mass spectral data obtained by at least one mass spectrometry device (112); b) (114) classifying quality of the chromatographic and/or mass spectral data by applying at least one trained machine learning model on the chromatographic and/or mass spectral data, wherein the trained machine learning model uses at least one regression model (116), wherein the trained machine learning model is trained on at least one training dataset comprising historical and/or semi-synthetic chromatographic and/or mass spectral data, wherein the trained machine learning model is an analyte-specific trained machine learning model.

IPC Classes  ?

83.

ANALYTICAL SYSTEM AND METHOD

      
Application Number 18694492
Status Pending
Filing Date 2022-09-22
First Publication Date 2024-11-21
Owner
  • Roche Diagnostics Operations, Inc. (USA)
  • Hitachi High-Tech Corporation (Japan)
Inventor
  • Lang, Robert
  • Mitra, Indranil
  • Hashimoto, Yuichiro
  • Sugawara, Yuka

Abstract

An analytical system comprising a mass spectrometer and an ionization source. The analytical system further comprises an analytical fluidic system connectable to the ionization source for infusing samples into the mass spectrometer via the ionization source, a downstream pump fluidically connectable to the ionization source via the downstream valve, where the downstream pump is fluidically connected to a plurality of fluid containers comprising respective fluids, the fluids comprising a concentrated composition for calibrating the mass spectrometer and at least one diluent for diluting the at least one concentrated composition. The analytical system further comprises a controller configured to control the downstream pump to obtain at least one diluted composition by automatically mixing a concentrated composition with a diluent with a predetermined dilution factor, to infuse the diluted composition into the ionization source, to obtain a mass spectrum of the diluted composition and to execute a calibration of the mass spectrometer. A respective automated analytical method.

IPC Classes  ?

84.

DOUBLE SINGLE-ION MONITORING MASS SPECTROMETRY

      
Application Number EP2024063474
Publication Number 2024/236093
Status In Force
Filing Date 2024-05-16
Publication Date 2024-11-21
Owner
  • ROCHE DIAGNOSTICS GMBH (Germany)
  • F. HOFFMANN-LA ROCHE AG (Switzerland)
  • ROCHE DIAGNOSTICS OPERATIONS, INC. (USA)
Inventor
  • Ciniawsky, Susanne
  • Leinenbach, Andreas
  • Mitra, Indranil
  • Nandania, Jatin

Abstract

The present invention relates to a method for determining an analyte in a mass spectrometry (MS) device comprising a first and a second mass filter, said method comprising (i) filtering for an analyte ion species in the first mass filter; (ii) optionally fragmenting at least a fraction of ions obtained by the filtering in step (i) in a collision cell, wherein the collision energy of said fragmenting is selected to be lower than a predetermined collision energy causing fragmentation of said analyte ion species; (iii) filtering for said analyte ion species filtered for in step (i) in the second mass filter, and (iv) detecting said analyte ion species filtered for in step (iii), thereby determining said analyte. Moreover, the present invention relates to devices, systems, and uses related to said method.

IPC Classes  ?

  • H01J 49/00 - Particle spectrometers or separator tubes

85.

NOVEL BIOTIN-SPECIFIC MONOCLONAL ANTIBODY AND USE THEREOF

      
Application Number 18669957
Status Pending
Filing Date 2024-05-21
First Publication Date 2024-11-14
Owner Roche Diagnostics Operations, Inc. (USA)
Inventor
  • Gerg, Michael
  • Heindl, Dieter
  • Hillringhaus, Lars
  • Hirzel, Klaus
  • Hojer, Caroline Dorothea
  • Huber, Florian
  • Josel, Hans-Peter
  • Meier, Thomas
  • Schraeml, Michael
  • Voss, Edgar

Abstract

The present invention relates to a monoclonal antibody capable of binding to biotin. In one embodiment the monoclonal antibody according to the invention also does not bind to a biotin moiety on a biotinylated molecule, wherein the biotin moiety is attached to the molecule via the carbon atom of the carboxyl function of the valeric acid moiety of biotin. Also disclosed is a method for generation of an antibody as disclosed herein. The monoclonal antibody according to the invention is of specific use in a method for measuring an analyte in a sample, wherein a (strept)avidin/biotin pair is used to bind a biotinylated analyte specific binding agent to a (strept)avidin coated solid phase.

IPC Classes  ?

  • G01N 33/543 - ImmunoassayBiospecific binding assayMaterials therefor with an insoluble carrier for immobilising immunochemicals
  • C07K 16/44 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material not provided for elsewhere

86.

METHODS AND SYSTEMS OF SAMPLE QUALITY VERIFICATION

      
Application Number 18636375
Status Pending
Filing Date 2024-04-16
First Publication Date 2024-11-07
Owner Roche Diagnostics Operations, Inc. (USA)
Inventor
  • Glauser, Michael
  • Gutmann, Oliver
  • Janner, Gabriele Piero
  • Sarofim, Emad
  • Schweighauser, Stephan
  • Thomann, Marcel
  • Vollenweider, Urs

Abstract

A computer-implemented method for optimising an assignment of one or more medical samples to one or more analytical tests to be conducted on those medical samples. The method comprises the steps of: obtaining an initial assignment of the one or more medical samples to the one or more analytical tests; determining a compliance status for the or each medical sample, the compliance status indicating: (i) whether a sample quality metric of the or each medical sample violates an analytical test specification of the medical sample's assigned analytical test(s) in the initial assignment and/or (ii) whether the or each medical sample is unprocessable; and performing a mitigation action if one or more compliance status indicate: (i) that the sample quality metric of a given medical sample violates the analytical test specification and/or (ii) a given medical sample is unprocessable.

IPC Classes  ?

  • G16H 10/40 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis

87.

TRANSPORT DEVICE AND LABORATORY SAMPLE DISTRIBUTION SYSTEM

      
Application Number 18649151
Status Pending
Filing Date 2024-04-29
First Publication Date 2024-11-07
Owner Roche Diagnostics Operations, Inc. (India)
Inventor
  • Sharpe, Nathaniel
  • Nussbaum, Matthew
  • Edelmann, Matthias
  • Bates, Christopher William

Abstract

The invention relates to a transport device for a laboratory sample distribution system, the transport device comprising a top cover having a transport surface, the transport surface being adapted to carry sample container carriers, an electromagnetic actuation assembly, the electromagnetic actuation assembly being adapted to generate a magnetic field at the transport surface for magnetic drive-interaction with a sample container carrier placed thereon, a support structure for carrying the actuation assembly, a sensor board being arranged in between the support structure and the top cover, the sensor board being adapted to detect a position of a sample container carrier placed on the transport surface with respect to the transport device, and elastic elements which are biased in between the sensor board and the support structure so that the sensor board is held flush against an inside surface of the top cover by a biasing force resulting from the biasing of the elastic elements.

IPC Classes  ?

  • B65G 54/02 - Non-mechanical conveyors not otherwise provided for electrostatic, electric, or magnetic
  • G01N 35/04 - Details of the conveyor system

88.

ON-BOARD CONJUGATION

      
Application Number 18645358
Status Pending
Filing Date 2024-04-24
First Publication Date 2024-10-31
Owner Roche Diagnostics Operations, Inc. (USA)
Inventor Hoogendijk, Jan-Gerrit

Abstract

The present invention relates to a method for labeling an analyte in a sample, said method comprising (a) providing a detection agent binding to the analyte and conjugating said detection agent with an indicator agent to produce a conjugation product; (b) contacting said sample with said conjugation product of step (a); wherein said step (b) is performed directly after completion of step (a) and wherein steps (a) and (b) are performed by the same labeling device; and to labeling devices, systems, and uses related thereto.

IPC Classes  ?

  • G01N 33/569 - ImmunoassayBiospecific binding assayMaterials therefor for microorganisms, e.g. protozoa, bacteria, viruses
  • G01N 33/543 - ImmunoassayBiospecific binding assayMaterials therefor with an insoluble carrier for immobilising immunochemicals

89.

ADJUSTABLE ADAPTER AND LABORATORY SYSTEM

      
Application Number 18642895
Status Pending
Filing Date 2024-04-23
First Publication Date 2024-10-31
Owner Roche Diagnostics Operations, Inc. (USA)
Inventor
  • Gutmann, Timo
  • Meyer, Sascha

Abstract

The invention relates to an adjustable adapter for closing a c-shaped gap in between two modules of a laboratory system, the adjustable adapter comprising a base extending along a width direction (W) of the adjustable adapter, and a pair of legs each protruding from the base in a length direction (L) of the adjustable adapter so that the base and the legs are arranged in a c-shape of the adjustable adapter, the base being adjustable to set its dimension (D, D1, D2) along the length direction (L).

IPC Classes  ?

  • B01L 9/02 - Laboratory benches or tablesFittings therefor

90.

A NOVEL ANTIBODY FOR DETECTION OF AMYLOID BETA 42 (AB42)

      
Application Number 18745539
Status Pending
Filing Date 2024-06-17
First Publication Date 2024-10-24
Owner Roche Diagnostics Operations, Inc. (USA)
Inventor
  • Jethwa, Alexander
  • Oelschlaegel, Tobias
  • Schindler, Corinna
  • Soukupova, Monika
  • Stoeckl, Laura
  • Zimmermann, Christina

Abstract

The present invention relates to a monoclonal antibody or an antigen-binding fragment thereof specifically binding to Aβ42 with advantageous features for Aβ42 detection in vitro using immunoassays. Also provided is a polynucleotide or a set of polynucleotides encoding the same and a vector comprising said polynucleotide(s). Further provided is a host cell comprising the polynucleotide(s) and a corresponding production process using this host cell. Also provided herein are uses and methods employing the monoclonal antibody or an antigen-binding fragment thereof specifically binding to Aβ42 as provided herein.

IPC Classes  ?

  • C07K 16/18 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans
  • G01N 33/543 - ImmunoassayBiospecific binding assayMaterials therefor with an insoluble carrier for immobilising immunochemicals
  • G01N 33/68 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing involving proteins, peptides or amino acids

91.

Automatic Analyzer

      
Application Number 18683438
Status Pending
Filing Date 2022-06-29
First Publication Date 2024-10-24
Owner
  • Hitachi High-Tech Corporation (Japan)
  • Roche Diagnostics Operation, Inc. (USA)
Inventor
  • Miyada, Yuki
  • Foester, Elisabeth
  • Steigenberger, Maximilian

Abstract

There is provided an automatic analyzer equipped with a disk-type container placement mechanism, which enables an operator to perform additional placement of a container during analysis operation. The automatic analyzer includes a storage unit previously stored with a sample container 103 holding a sample before measurement of the sample, a dispensing mechanism 4 that sucks the sample from the sample container, an input unit that receives a command to store an emergency sample in the storage unit, the control unit 7 that controls such that, after a first operation being performed by the dispensing mechanism at a point of time when the command is received is completed, a second operation scheduled to be performed next by the dispensing mechanism is not started, and a display unit that prompts a user to store the emergency sample in the storage unit, in which the storage unit includes a first storage unit that stores an ordinary sample and a second storage unit that stores the emergency sample, and after controlling such that the second operation is not started, the control unit controls the second storage unit to move to a position where the emergency sample is inserted by a user.

IPC Classes  ?

  • G01N 35/00 - Automatic analysis not limited to methods or materials provided for in any single one of groups Handling materials therefor
  • G01N 35/02 - Automatic analysis not limited to methods or materials provided for in any single one of groups Handling materials therefor using a plurality of sample containers moved by a conveyor system past one or more treatment or analysis stations
  • G01N 35/10 - Devices for transferring samples to, in, or from, the analysis apparatus, e.g. suction devices, injection devices

92.

SYSTEMS AND METHODS FOR SECURE DATA STORAGE

      
Application Number 18618670
Status Pending
Filing Date 2024-03-27
First Publication Date 2024-10-17
Owner Roche Diagnostics Operations, Inc. (USA)
Inventor
  • Alex Namasivayam, Aishwarya
  • Britz, Jochen
  • Bucheli, Stefan
  • Cristino, Ricardo
  • Findeisen, Stanislaw
  • Kocademir, Alper
  • Roy, Sudipto Shekhar
  • Sonnenberg, Gerhard

Abstract

A system for securely storing data, such as sensitive personal data, including an interface configured with a REST API, an authentication module, at least one target database for storing the data, and a data access module which is configured to receive requests from a client computer by means of the interface, query data from the at least one target database in response to the received request, determine whether the client computer and/or the user has permission to query, and generate a response data set to respond to the request and transmit it to the client computer, wherein at least some data of the response data set is anonymised if restricted authentication is determined.

IPC Classes  ?

  • G06F 21/62 - Protecting access to data via a platform, e.g. using keys or access control rules

93.

METHOD AND SENSOR DEVICE FOR DETERMINING THE CONCENTRATION OF AN ANALYTE IN A SAMPLE

      
Application Number 18751505
Status Pending
Filing Date 2024-06-24
First Publication Date 2024-10-17
Owner Roche Diagnostics Operations, Inc. (USA)
Inventor
  • Bradbury, Christopher
  • Gutiérrez-Sanz, Oscar

Abstract

A method of determining the concentration of an analyte comprising: providing a sensor device comprising: a field effect transistor having a source electrode, a drain electrode and a gate electrode, a sensing electrode electrically connected or integrated into the gate electrode, and a control device for applying operation parameters to the field effect transistor and for monitoring a signal value with the field effect transistor; selecting a set of operation parameters of the field effect transistor, the selecting comprising performing evaluation measurements with the field effect transistor using various sets of operation parameter candidates and selecting a set in accordance with optimization criterion monitored during the evaluation measurements; and detecting the concentration by applying the selected set of operation parameters to the field effect transistor and determining a signal value with the field effect transistor. A method of determining the concentration of an analyte comprising: providing a sensor device comprising: a field effect transistor having a source electrode, a drain electrode and a gate electrode, a sensing electrode electrically connected or integrated into the gate electrode, and a control device for applying operation parameters to the field effect transistor and for monitoring a signal value with the field effect transistor; selecting a set of operation parameters of the field effect transistor, the selecting comprising performing evaluation measurements with the field effect transistor using various sets of operation parameter candidates and selecting a set in accordance with optimization criterion monitored during the evaluation measurements; and detecting the concentration by applying the selected set of operation parameters to the field effect transistor and determining a signal value with the field effect transistor. Further, a sensor device for determining the concentration of an analyte in a sample.

IPC Classes  ?

  • G01N 27/414 - Ion-sensitive or chemical field-effect transistors, i.e. ISFETS or CHEMFETS
  • G01N 33/543 - ImmunoassayBiospecific binding assayMaterials therefor with an insoluble carrier for immobilising immunochemicals

94.

LABORATORY APPARATUS, LABORATORY SYSTEM, AND USE

      
Application Number 18750107
Status Pending
Filing Date 2024-06-21
First Publication Date 2024-10-17
Owner Roche Diagnostics Operations, Inc. (USA)
Inventor
  • Apodaca Lujan, Leon Felipe
  • Gutmann, Timo

Abstract

A laboratory apparatus comprising a housing, wherein the housing comprises a through-opening, wherein the through-opening is adapted for passing through it a transport device for transporting laboratory sample containers in and/or out of the housing, and a cover, wherein the cover comprises at least two ring segments, wherein the ring segments are adjustable to each other between a distant adjustment with at least one distance in between ends of the ring segments for arranging them around the passed through transport device and a near adjustment with less or no distance in between the ends of the ring segments for surrounding the passed through transport device, and wherein the cover in the near adjustment is adapted to cover a part of the through-opening left free by the passed through transport device, wherein the laboratory apparatus is a pre-analytical, analytical, and/or post-analytical laboratory apparatus, in particular a sorting module.

IPC Classes  ?

95.

MODIFIED ANTIBODY FOR SITE-SPECIFIC CONJUGATION AND ITS DIAGNOSTIC USE

      
Application Number 18752484
Status Pending
Filing Date 2024-06-24
First Publication Date 2024-10-17
Owner Roche Diagnostics Operations, Inc. (USA)
Inventor
  • Mohamed, Mohamed Yosry Hassan
  • Oelschlaegel, Tobias

Abstract

The present invention relates to a modified antibody comprising a heavy chain and a light chain, wherein the antibody is modified to include in one or more of its immunoglobulin polypeptide chains one or more first recognition site(s) for the transglutaminase from Kutzneria albida (KalbTG) or a functionally active variant thereof. The one or more first recognition site(s) are introduced at one or more selected position(s) within an antibody's heavy chain and/or an antibody's light chain. The invention further relates to one or more nucleic acid(s) encoding an immunoglobulin polypeptide chain including the one or more recognition site(s), a site-specifically conjugated antibody comprising the modified antibody and one or more labelling domain(s) covalently attached to one or more first recognition sites, a kit for producing the conjugated antibody, a method of specifically labelling the modified antibody by way of site-specific conjugation, the use of the modified antibody for producing a specifically site-specifically conjugated antibody, a method of detecting a target in a sample and the use of the site-specifically conjugated antibody in the detection of a target and/or in the diagnosis.

IPC Classes  ?

  • C07K 16/40 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against enzymes
  • G01N 33/68 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing involving proteins, peptides or amino acids

96.

IN VITRO CULTIVATION METHOD FOR ANTIBODY EXPRESSING CELLS

      
Application Number EP2024059116
Publication Number 2024/208936
Status In Force
Filing Date 2024-04-04
Publication Date 2024-10-10
Owner
  • F. HOFFMANN-LA ROCHE AG (Switzerland)
  • ROCHE DIAGNOSTICS GMBH (Germany)
  • ROCHE DIAGNOSTICS OPERATIONS, INC. (USA)
Inventor
  • Brockhaus, Janis
  • Buchenberg, Sebastian
  • Hojer, Caroline Dorothea
  • Meier, Thomas

Abstract

The present invention relates to an in vitro method for cultivating one or more antibody expressing cell(s). The method comprises cultivating one or more antibody expressing cell(s) obtained from peripheral blood in the presence of IL-2, IL-21 and a non-cell surface presented CD40-stimulating agent and in the absence of feeder cells. Moreover, herein provided are methods for producing antibodies comprising the step of cultivating one or more antibody expressing cell(s) according to the method of the invention, a novel CD40-stimulating agent and uses therefrom as well as a cell culture medium.

IPC Classes  ?

97.

LIGHT SOURCE FOR GENERATING ILLUMINATION LIGHT

      
Application Number 18620273
Status Pending
Filing Date 2024-03-28
First Publication Date 2024-10-10
Owner Roche Diagnostics Operations, Inc. (USA)
Inventor Salzmann, Wenzel

Abstract

A light source (112) for generating illumination light for illuminating at least one sample is disclosed. The light source (112) comprises at least one array of light emitters (114), wherein each of the light emitters (114) is configured for emitting at least one light beam along a light beam path, wherein the light beam has a predefined wavelength range, and at least one reflective optical grating (116) configured for overlaying the light beam paths, at least one transfer element (118); wherein the transfer element (118) is arranged between the array of light emitters (114) and the optical grating (116) such that the transfer element (118) directs the emitted light beams onto the optical grating (116) and provides the light beams reflected from the optical grating (116) and impinging on the transfer element (118) into at least one measurement channel (120), wherein the measurement channel (120) is configured for receiving at least one sample.

IPC Classes  ?

  • G01N 21/359 - Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry using infrared light using near infrared light
  • G01N 21/33 - Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry using ultraviolet light
  • G01N 21/3577 - Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry using infrared light for analysing liquids, e.g. polluted water

98.

COBAS TURN

      
Serial Number 98792186
Status Pending
Filing Date 2024-10-09
Owner Roche Diagnostics Operations, Inc. ()
NICE Classes  ?
  • 05 - Pharmaceutical, veterinary and sanitary products
  • 10 - Medical apparatus and instruments

Goods & Services

Medical diagnostic reagents, namely, chemical, biochemical and biological-based medical diagnostic reagents; diagnostic reagents for clinical medical purposes; medical diagnostic reagents for clinical medical purposes; diagnostic reagents for medical use in in-vitro diagnosis used by medical laboratories Medical apparatus, namely, clinical chemistry analyzers for use in the analysis of biological samples for the presence, absence, or quantity of medically significant analytes for clinical medical diagnostic purposes

99.

TRANSFER DEVICE FOR TRANSFERRING SAMPLE CONTAINERS IN A SAMPLE HANDLING SYSTEM

      
Application Number 18579561
Status Pending
Filing Date 2022-07-15
First Publication Date 2024-10-03
Owner Roche Diagnostics Operations, Inc. (USA)
Inventor
  • Narayana, Avinash Addihalli
  • Huber, Tobias

Abstract

A transfer device (110) for transferring sample containers in a sample handling system (112) is disclosed. The transfer device (110) comprises: at least one transport device (114) comprising an array (116) of electromagnetic actuators (118), specifically electromagnetic actuators (118) comprising electromagnetic coils (120); at least one moving unit (122) comprising at least one permanent magnet (124), wherein the moving unit (122) is movable in at least one movement plane (126), specifically in at least one movement plane (126) of the moving unit (122) defined by at least two moving directions (128), through the array (116) by magnetic interaction of the permanent magnet (124) with the electromagnetic actuators (118); and at least one gripper unit (130) for positioning at least one of the sample containers, wherein the gripper unit (130) is movable in at least one gripping direction (132) essentially perpendicular to the movement plane (126), wherein the gripping unit (130) is attached to the moving unit (122). A transfer device (110) for transferring sample containers in a sample handling system (112) is disclosed. The transfer device (110) comprises: at least one transport device (114) comprising an array (116) of electromagnetic actuators (118), specifically electromagnetic actuators (118) comprising electromagnetic coils (120); at least one moving unit (122) comprising at least one permanent magnet (124), wherein the moving unit (122) is movable in at least one movement plane (126), specifically in at least one movement plane (126) of the moving unit (122) defined by at least two moving directions (128), through the array (116) by magnetic interaction of the permanent magnet (124) with the electromagnetic actuators (118); and at least one gripper unit (130) for positioning at least one of the sample containers, wherein the gripper unit (130) is movable in at least one gripping direction (132) essentially perpendicular to the movement plane (126), wherein the gripping unit (130) is attached to the moving unit (122). Further disclosed is a sample handling system (112) for handling a plurality of sample containers and a method for transferring sample containers in a sample handling system (112).

IPC Classes  ?

  • G01N 35/00 - Automatic analysis not limited to methods or materials provided for in any single one of groups Handling materials therefor
  • B25J 15/02 - Gripping heads servo-actuated

100.

METHOD FOR DETERMINING AN ANALYTE OF INTEREST BY FREQUENCY DETECTION

      
Application Number 18672786
Status Pending
Filing Date 2024-05-23
First Publication Date 2024-09-19
Owner Roche Diagnostics Operations, Inc. (USA)
Inventor
  • Rempt, Martin
  • Wellner, Christian

Abstract

The present invention relates to a method for determining an analyte of interest by frequency detection and the use thereof, a modified nanopore, an analyzing system, a kit and the uses thereof.

IPC Classes  ?

  • G01N 33/487 - Physical analysis of biological material of liquid biological material
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