The present subject matter is directed to a composition for staining cytological material comprising a cationic dye component, a hygroscopic polyol and optionally a water-soluble solvent, water or water-miscible solvent, methods of use of the compositions. Advantageously, the present compositions do not require the use of a cover slide as is required in known staining fixatives. The compositions are able to retain cell morphology for a period of time such that a cover slide is not required. Further, the compositions do not contain hazardous levels of organic components. Preferably, the compositions consist essentially of Azure C, glycerol and optionally water. In another aspect, the present subject matter is directed to a method of characterizing a cell sample comprising contacting the cell sample with a composition comprising a dye component and a hygroscopic polyol and subjecting the sample to analysis to determine the presence or absence of abnormal cells.
The present invention is directed to a pre-coated substrate, such as a slide, that is useful for immobilizing a sample. The invention is further provides methods of preparing such pre-coated substrates and methods of analyzing biological samples immobilized on such pre-coated substrate. The substrate is coated with a polycationic polymeric coating material specifically selected such that that coated substrate exhibits increased stability and prolonged shelf-life. Preferred polymeric coating materials include allylic or vinylic polymers having cationic groups thereon and having no more than a small percentage of peptidic monomeric linkages, particularly polydiallyldimethylammonium (PDDA).
The present subject matter is directed to a composition for staining cytological material comprising a cationic dye component, a hygroscopic polyol and optionally a water-soluble solvent, water or water-miscible solvent, methods of use of the compositions. Advantageously, the present compositions do not require the use of a cover slide as is required in known staining fixatives. The compositions are able to retain cell morphology for a period of time such that a cover slide is not required. Further, the compositions do not contain hazardous levels of organic components. Preferably, the compositions consist essentially of Azure C, glycerol and optionally water. In another aspect, the present subject matter is directed to a method of characterizing a cell sample comprising contacting the cell sample with a composition comprising a dye component and a hygroscopic polyol and subjecting the sample to analysis to determine the presence or absence of abnormal cells.
A sample tube holder assembly may include a base comprising a base cavity defined therein. The sample tube holder assembly may include at least one first engagement member disposed within the base cavity and a plurality of sample tube holder racks configured to be received within the base cavity, at least one of the sample tube holder racks comprising at least one second engagement member, wherein each of the plurality of sample tube holder racks further comprises at least one sample tube cavity configured to receive a respective sample tube therein. The first and second engagement members may be configured to engage with one another when the plurality of sample tube holder racks are positioned within the base cavity such that the sample tube holder racks are offset at a different depth from one another within the base cavity.
The invention provides an integrated sequential sample preparation system using a sequential centrifuge for preparing samples for analysis. Methods of more efficiently preparing discrete samples sequentially for subsequent analysis are also provided. The apparatus and methods for sequentially preparing discrete samples provide improved operating efficiencies over conventional preparation processes that use batch centrifugation systems. Such advantages include reducing dwell time, increasing system throughput, reducing sample preparation system footprint, and improving precision of the analytical process. The integrated sequential preparation system with the integrated sequential centrifuge further provides the capability of handling critical or STAT samples without compromising the operating efficiencies achieved by preparing discrete samples in a sequential manner.
The present subject matter is directed to compositions and methods for inhibiting or preventing contamination of a cytological sample for analysis, wherein the sample is associated with a substrate. The methods disclosed herein are directed to contacting a polyanionic polymer material with a sample that is affixed to a substrate, which has a net cationic charge density. Upon contacting the sample with the polyanionic solution, contamination of the sample by other biological material, particularly cells, is inhibited or prevented.
The present subject matter is directed to a composition for staining cytological material comprising a cationic dye component, a hygroscopic polyol and optionally a water-soluble solvent, water or water-miscible solvent, methods of use of the compositions. Advantageously, the present compositions do not require the use of a cover slide as is required in known staining fixatives. The compositions are able to retain cell morphology for a period of time such that a cover slide is not required. Further, the compositions do not contain hazardous levels of organic components. Preferably, the compositions consist essentially of Azure C, glycerol and optionally water. In another aspect, the present subject matter is directed to a method of characterizing a cell sample comprising contacting the cell sample with a composition comprising a dye component and a hygroscopic polyol and subjecting the sample to analysis to determine the presence or absence of abnormal cells.
A01N 37/52 - Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom having three bonds to hetero atoms with at the most two bonds to halogen, e.g. carboxylic acids containing groups, e.g. carboxylic acid amidines
A sample tube holder assembly may include a base comprising a base cavity defined therein. The sample tube holder assembly may include at least one first engagement member disposed within the base cavity and a plurality of sample tube holder racks configured to be received within the base cavity, at least one of the sample tube holder racks comprising at least one second engagement member, wherein each of the plurality of sample tube holder racks further comprises at least one sample tube cavity configured to receive a respective sample tube therein. The first and second engagement members may be configured to engage with one another when the plurality of sample tube holder racks are positioned within the base cavity such that the sample tube holder racks are offset at a different depth from one another within the base cavity.
The present invention is directed to a pre-coated substrate, such as a slide, that is useful for immobilizing a sample. The invention is further provides methods of preparing such pre-coated substrates and methods of analyzing biological samples immobilized on such pre-coated substrate. The substrate is coated with a polycationic polymeric coating material specifically selected such that that coated substrate exhibits increased stability and prolonged shelf-life. Preferred polymeric coating materials include allylic or vinylic polymers having cationic groups thereon and having no more than a small percentage of peptidic monomeric linkages, particularly polydiallyldimethylammonium (PDDA).
Methods for chromogen separation-based image analysis are provided, with such methods being directed to quantitative video-microscopy techniques in cellular biology and pathology applications.
Compositions and methods for preparing a sample for immunological staining are provided. Compositions include kits comprising a first solution comprising a surfactant and a second solution comprising a chaotropic agent. Methods comprise contacting a sample, such as cells or tissues, with a first solution comprising a surfactant and then contacting the sample with a second solution comprising a chaotropic agent. The method does not require extreme heat for antigen retrieval and therefore, maintains the cellular morphology of the sample.
Compositions and methods for preparing a sample for immunological staining are provided. Compositions include kits comprising a first solution comprising a surfactant and a second solution comprising a chaotropic agent. Methods comprise contacting a sample, such as cells or tissues, with a first solution comprising a surfactant and then contacting the sample with a second solution comprising a chaotropic agent. The method does not require extreme heat for antigen retrieval and therefore, maintains the cellular morphology of the sample.
Compositions and methods for diagnosing ovarian cancer in a patient and for identifying patients with an increased likelihood of having ovarian cancer are provided. The compositions include novel monoclonal antibodies, and variants and fragments thereof, that specifically bind to glycodelin. Monoclonal antibodies having the binding characteristics of a glycodelin antibody of the invention and monoclonal antibodies that bind to a glycodelin epitope of a disclosed antibody are further provided. Hybridoma cell lines that produce a glycodelin monoclonal antibody of the invention are also disclosed herein. Kits comprising one or more of the disclosed glycodelin monoclonal antibodies and for practicing the methods of the invention are further provided. Polypeptides comprising the amino acid sequence for a glycodelin epitope of a disclosed monoclonal glycodelin antibody and methods of using these polypeptides in the production of glycodelin antibodies are also encompassed by the present invention.
Embodiments of the present invention are directed to a method for calibrating an imaging system for analyzing a plurality of molecular species in a sample. According to one embodiment, the method comprises acquiring a plurality of images of the sample with an image acquisition device at a plurality of different wavelengths, comparing a region of interest associated with at least one of the images acquired at one respective wavelength to a region of interest associated with at least one of the images acquired at a different wavelength, and aligning the plurality of images such that the region of interest associated with at least one of the images acquired at one respective wavelength corresponds to the region of interest associated with the at least one of the images acquired at a different wavelength.
Embodiments of the present invention are directed to a method for determining an amount of a plurality of molecular species in a sample, each molecular specie being indicated by a dye. According to one embodiment, the amount of a plurality of molecular species is determined by acquiring a plurality of images of the sample, determining an amount of each molecular specie, as indicated by a respective dye, for each pixel at each corresponding pixel location in the plurality of images, and refining the amount of a plurality of molecular species at one or more pixel locations in the plurality of images. Associated systems and computer program products are also provided.
Embodiments of the present invention are directed to a method for determining an amount of a plurality of molecular species in a sample, each molecular specie being indicated by a dye. According to one embodiment, the amount of a plurality of molecular species is determined by acquiring a plurality of images of the sample, determining an amount of each molecular specie, as indicated by a respective dye, for each pixel at each corresponding pixel location in the plurality of images, and refining the amount of a plurality of molecular species at one or more pixel locations in the plurality of images. Associated systems and computer program products are also provided.
Embodiments of the present invention are directed to a method for calibrating an imaging system for analyzing a plurality of molecular species in a sample. According to one embodiment, the method comprises acquiring a plurality of images of the sample with an image acquisition device at a plurality of different wavelengths, comparing a region of interest associated with at least one of the images acquired at one respective wavelength to a region of interest associated with at least one of the images acquired at a different wavelength, and aligning the plurality of images such that the region of interest associated with at least one of the images acquired at one respective wavelength corresponds to the region of interest associated with the at least one of the images acquired at a different wavelength.
Embodiments of the present invention are directed to a method for calibrating an imaging system for analyzing a plurality of molecular species in a sample. According to one embodiment, the method comprises acquiring a plurality of images of the sample with an image acquisition device at a plurality of different wavelengths, comparing a region of interest associated with at least one of the images acquired at one respective wavelength to a region of interest associated with at least one of the images acquired at a different wavelength, and aligning the plurality of images such that the region of interest associated with at least one of the images acquired at one respective wavelength corresponds to the region of interest associated with the at least one of the images acquired at a different wavelength.
Compositions and methods for diagnosing high-grade cervical disease in a patient sample are provided. The compositions include novel monoclonal antibodies, and variants and fragments thereof, that specifically bind to MCM6 or MCM7. Monoclonal antibodies having the binding characteristics of an MCM6 or MCM7 antibody of the invention are further provided. Hybridoma cell lines that produce an MCM6 or MCM7 monoclonal antibody of the invention are also disclosed herein. The compositions find use in practicing methods for diagnosing high-grade cervical disease comprising detecting overexpression of MCM6, MCM7, or both MCM6 and MCM7 in a cervical sample from a patient. Kits for practicing the methods of the invention are further provided. Polypeptides comprising the amino acid sequence for an MCM6 or an MCM7 epitope and methods of using these polypeptides in the production of antibodies are also encompassed by the present invention.
The invention provides an integrated sequential sample preparation system using a sequential centrifuge for preparing samples for analysis. Methods of more efficiently preparing discrete samples sequentially for subsequent analysis are also provided. The apparatus and methods for sequentially preparing discrete samples provide improved operating efficiencies over conventional preparation processes that use batch centrifugation systems. Such advantages include reducing dwell time, increasing system throughput, reducing sample preparation system footprint, and improving precision of the analytical process. The integrated sequential preparation system with the integrated sequential centrifuge further provides the capability of handling critical or STAT samples without compromising the operating efficiencies achieved by preparing discrete samples in a sequential manner.
G01N 21/00 - Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
G01N 31/00 - Investigating or analysing non-biological materials by the use of the chemical methods specified in the subgroupsApparatus specially adapted for such methods
G01N 33/00 - Investigating or analysing materials by specific methods not covered by groups
G01N 9/30 - Investigating density or specific gravity of materialsAnalysing materials by determining density or specific gravity by using centrifugal effects
G01N 35/00 - Automatic analysis not limited to methods or materials provided for in any single one of groups Handling materials therefor
B01L 3/00 - Containers or dishes for laboratory use, e.g. laboratory glasswareDroppers
B04B 11/04 - Periodical feeding or dischargingControl arrangements therefor
The invention provides a sequential centrifuge for centrifuging discrete samples. Methods of more efficiently centrifuging discrete samples sequentially are also provided. The apparatus and methods for sequentially centrifuging discrete samples provide improved operating efficiencies over conventional batch centrifuges. Such advantages include reducing dwell time, increasing system throughput, reducing sample processing system footprint, and improving precision of the analytical process. The sequential centrifuge further provides the capability of handling critical samples without compromising the operating efficiencies achieved in centrifuging discrete samples in a sequential manner.
Compositions and methods for diagnosing ovarian cancer in a patient and for identifying patients with an increased likelihood of having ovarian cancer are provided. The compositions include novel monoclonal antibodies, and variants and fragments thereof, that specifically bind to MMP-7. Monoclonal antibodies having the binding characteristics of an MMP-7 antibody of the invention and monoclonal antibodies that bind to an MMP-7 epitope of a disclosed antibody are further provided. Hybridoma cell lines that produce an MMP-7 monoclonal antibody of the invention are also disclosed herein. The compositions find use in diagnostic methods as well as in screening methods for identifying patients having an increased likelihood of having ovarian cancer. Kits comprising one or more of the disclosed MMP-7 monoclonal antibodies and for practicing the methods of the invention are further provided. Polypeptides comprising the amino acid sequence for an MMP-7 epitope of a disclosed monoclonal MMP-7 antibody and methods of using these polypeptides in the production of MMP-7 antibodies are also encompassed by the present invention.
Compositions and methods for diagnosing ovarian cancer in a patient and for identifying patients with an increased likelihood of having ovarian cancer are provided. The compositions include novel monoclonal antibodies, and variants and fragments thereof, that specifically bind to glycodelin. Monoclonal antibodies having the binding characteristics of a glycodelin antibody of the invention and monoclonal antibodies that bind to a glycodelin epitope of a disclosed antibody are further provided. Hybridoma cell lines that produce a glycodelin monoclonal antibody of the invention are also disclosed herein. The compositions find use in diagnostic methods as well as in screening methods for identifying patients having an increased likelihood of having ovarian cancer. Kits comprising one or more of the disclosed glycodelin monoclonal antibodies and for practicing the methods of the invention are further provided. Polypeptides comprising the amino acid sequence for a glycodelin epitope of a disclosed monoclonal glycodelin antibody and methods of using these polypeptides in the production of glycodelin antibodies are also encompassed by the present invention.
C07K 16/18 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans
C07K 16/30 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
Compositions and methods for diagnosing ovarian cancer in a patient and for identifying patients with an increased likelihood of having ovarian cancer are provided. The compositions include novel monoclonal antibodies, and variants and fragments thereof, that specifically bind to glycodelin. Monoclonal antibodies having the binding characteristics of a glycodelin antibody of the invention and monoclonal antibodies that bind to a glycodelin epitope of a disclosed antibody are further provided. Hybridoma cell lines that produce a glycodelin monoclonal antibody of the invention are also disclosed herein. The compositions find use in diagnostic methods as well as in screening methods for identifying patients having an increased likelihood of having ovarian cancer. Kits comprising one or more of the disclosed glycodelin monoclonal antibodies and for practicing the methods of the invention are further provided. Polypeptides comprising the amino acid sequence for a glycodelin epitope of a disclosed monoclonal glycodelin antibody and methods of using these polypeptides in the production of glycodelin antibodies are also encompassed by the present invention.
Methods for chromogen separation-based image analysis are provided, with such methods being directed to quantitative video-microscopy techniques in cellular biology and pathology applications.
Methods for chromogen separation-based image analysis are provided, with such methods being directed to quantitative video-microscopy techniques in cellular biology and pathology applications.
G06K 9/00 - Methods or arrangements for reading or recognising printed or written characters or for recognising patterns, e.g. fingerprints
G06E 1/04 - Devices for processing exclusively digital data operating upon the order or content of the data handled for performing computations using exclusively denominational number representation, e.g. using binary, ternary, decimal representation
28.
Monoclonal antibodies and methods for their use in the detection of cervical disease
Compositions and methods for diagnosing high-grade cervical disease in a patient sample are provided. The compositions include novel monoclonal antibodies, and variants and fragments thereof, that specifically bind to MCM2. Monoclonal antibodies having the binding characteristics of an MCM2 antibody of the invention are further provided. Hybridoma cell lines that produce an MCM2 monoclonal antibody of the invention are also disclosed herein. The compositions find use in practicing methods for diagnosing high-grade cervical disease comprising detecting overexpression of MCM2 in a cervical sample from a patient. Kits for practicing the methods of the invention are further provided. Polypeptides comprising the amino acid sequence for an MCM2 epitope and methods of using these polypeptides in the production of antibodies are also encompassed by the present invention.
The invention provides an integrated sequential sample preparation system using a sequential centrifuge for preparing samples for analysis. Methods of more efficiently preparing discrete samples sequentially for subsequent analysis are also provided. The apparatus and methods for sequentially preparing discrete samples provide improved operating efficiencies over conventional preparation processes that use batch centrifugation systems. Such advantages include reducing dwell time, increasing system throughput, reducing sample preparation system footprint, and improving precision of the analytical process. The integrated sequential preparation system with the integrated sequential centrifuge further provides the capability of handling critical or STAT samples without compromising the operating efficiencies achieved by preparing discrete samples in a sequential manner.
G01N 35/00 - Automatic analysis not limited to methods or materials provided for in any single one of groups Handling materials therefor
B04B 11/04 - Periodical feeding or dischargingControl arrangements 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
The invention provides a sequential centrifuge for centrifuging discrete samples. Methods of more efficiently centrifuging discrete samples sequentially are also provided. The apparatus and methods for sequentially centrifuging discrete samples provide improved operating efficiencies over conventional batch centrifuges. Such advantages include reducing dwell time, increasing system throughput, reducing sample processing system footprint, and improving precision of the analytical process. The sequential centrifuge further provides the capability of handling critical samples without compromising the operating efficiencies achieved in centrifuging discrete samples in a sequential manner.
Methods and compositions for identifying ovarian cancer in a patient sample are provided. The methods of the invention comprise detecting overexpression or underexpression of at least one nucleic acid biomarker in a body sample, wherein the biomarker is selectively overexpressed or underexpressed in ovarian cancer. The body sample may be, for example, an ovarian tissue sample. The biomarkers of the invention include any nucleic acid molecule that is selectively overexpressed in ovarian cancer, including, for example, MMP-7, PAEP, CA125, HE4, PLAUR, MUC-I, SLPI, SSPl, MSLN, SPONl, interleukin-7, folate receptor 1, claudin 3, inhibin A, inhibin BB, inhibin BA, and PAI-I. Overexpression or underexpression of a biomarker of interest is detected at the nucleic acid level using such methods as realtime PCR and various nucleic acid hybridization techniques. Kits for practicing the methods of the invention are further provided.
Compositions and methods for diagnosing high-grade cervical disease in a patient sample are provided. The compositions include novel monoclonal antibodies, and variants and fragments thereof, that specifically bind to MCM6 or MCM7. Monoclonal antibodies having the binding characteristics of an MCM6 or MCM7 antibody of the invention are further provided. Hybridoma cell lines that produce an MCM6 or MCM7 monoclonal antibody of the invention are also disclosed herein. The compositions find use in practicing methods for diagnosing high-grade cervical disease comprising detecting overexpression of MCM6, MCM7, or both MCM6 and MCM7 in a cervical sample from a patient. Kits for practicing the methods of the invention are further provided. Polypeptides comprising the amino acid sequence for an MCM6 or an MCM7 epitope and methods of using these polypeptides in the production of antibodies are also encompassed by the present invention.
A method of capturing a focused image of a continuously moving slide/objective arrangement is provided. A frame grabber device is triggered to capture an image of the slide through an objective at a first focus level as the slide continuously moves laterally relative to the objective. Alternatingly with triggering the frame grabber device, the objective is triggered to move to a second focus level after capture of the image of the slide. The objective moves in discrete steps, oscillating between minimum and maximum focus levels. The frame grabber device is triggered at a frequency as the slide continuously moves laterally relative to the objective so multiple images at different focus levels overlap, whereby a slide portion is common to each. The image having the maximum contrast value within overlapping images represents an optimum focus level for the slide portion, and thus the focused image. Associated apparatuses and methods are also provided.
Compositions and methods for diagnosing ovarian cancer in a patient and for identifying patients with an increased likelihood of having ovarian cancer are provided. The compositions include monoclonal antibodies, and variants and fragments thereof, that specifically bind to HE4. Monoclonal antibodies having the binding characteristics of an HE4 antibody of the invention are further provided. Hybridoma cell lines that produce an HE4 monoclonal^ antibody of the invention are also disclosed herein. The compositions find use in diagnostic methods as well as in screening methods for identifying patients having an increased likelihood of having ovarian cancer. Kits comprising one or more of the disclosed HE4 monoclonal antibodies and for practicing the methods of the invention are further provided. Polypeptides comprising the amino acid sequence for an HE4 epitope and methods of using these polypeptides in the production of antibodies are also encompassed by the present invention.
C07K 16/30 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
C07K 14/47 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from animalsPeptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from humans from vertebrates from mammals
A pressure-responsive container assembly and elastically-deformable penetrable cap is provided. Embodiments of the penetrable cap of the present invention include, but are not limited to: an annular sealing portion for engaging an inner surface of a container, a substantially rigid portion extending radially inward from the annular sealing portion; a flexible transition portion extending radially inward from the substantially rigid portion; and a penetrable portion extending radially inward from the transition portion for closing the opening defined by the container. Thus, embodiments of the present invention may thus allow the penetrable portion to elastically deform about the transition portion to a generally convex shape so as to exert a radially outward force that may be transmitted by the substantially rigid portion to the annular sealing portion so as to reinforce a fluid-tight seal between the annular sealing portion and the inner surface of the container.
A pressure-responsive container assembly and elastically-deformable penetrable cap is provided. Embodiments of the penetrable cap of the present invention include, but are not limited to: an annular sealing portion for engaging an inner surface of a container, a substantially rigid portion extending radially inward from the annular sealing portion; a flexible transition portion extending radially inward from the substantially rigid portion; and a penetrable portion extending radially inward from the transition portion for closing the opening defined by the container. Thus, embodiments of the present invention may thus allow the penetrable portion to elastically deform about the transition portion to a generally convex shape so as to exert a radially outward force that may be transmitted by the substantially rigid portion to the annular sealing portion so as to reinforce a fluid-tight seal between the annular sealing portion and the inner surface of the container.
A pressure-responsive container assembly and elastically-deformable penetrable cap is provided. Embodiments of the penetrable cap of the present invention include, but are not limited to: an annular sealing portion for engaging an inner surface of a container, a substantially rigid portion extending radially inward from the annular sealing portion; a flexible transition portion extending radially inward from the substantially rigid portion; and a penetrable portion extending radially inward from the transition portion for closing the opening defined by the container. Thus, embodiments of the present invention may thus allow the penetrable portion to elastically deform about the transition portion to a generally convex shape so as to exert a radially outward force that may be transmitted by the substantially rigid portion to the annular sealing portion so as to reinforce a fluid-tight seal between the annular sealing portion and the inner surface of the container.
B65D 41/00 - Caps, e.g. crown caps or crown seals, i.e. members having parts arranged for engagement with the external periphery of a neck or wall defining a pouring opening or discharge apertureProtective cap-like covers for closure members, e.g. decorative covers of metal foil or paper
B01L 99/00 - Subject matter not provided for in other groups of this subclass
A61B 19/00 - Instruments, implements or accessories for surgery or diagnosis not covered by any of the groups A61B 1/00-A61B 18/00, e.g. for stereotaxis, sterile operation, luxation treatment, wound edge protectors(protective face masks A41D 13/11; surgeons' or patients' gowns or dresses A41D 13/12; devices for carrying-off, for treatment of, or for carrying-over, body liquids A61M 1/00)
38.
MCM6 and MCM7 monoclonal antibodies and methods for their use in the detection of cervical disease
Compositions and methods for diagnosing high-grade cervical disease in a patient sample are provided. The compositions include novel monoclonal antibodies, and variants and fragments thereof, that specifically bind to MCM6 or MCM7. Monoclonal antibodies having the binding characteristics of an MCM6 or MCM7 antibody of the invention are further provided. Hybridoma cell lines that produce an MCM6 or MCM7 monoclonal antibody of the invention are also disclosed herein. The compositions find use in practicing methods for diagnosing high-grade cervical disease comprising detecting overexpression of MCM6, MCM7, or both MCM6 and MCM7 in a cervical sample from a patient. Kits for practicing the methods of the invention are further provided. Polypeptides comprising the amino acid sequence for an MCM6 or an MCM7 epitope and methods of using these polypeptides in the production of antibodies are also encompassed by the present invention.
Screening methods for identifying patients with an increased likelihood of having ovarian cancer are provided. The screening methods involve the detection of expression of a plurality of biomarkers in a body sample, wherein overexpression of the biomarkers is indicative of an increased likelihood of having ovarian cancer. The screening methods may further comprise a two-step analysis. Biomarkers of interest include genes and proteins that are, for example, involved in defects in DNA replication/cell cycle control, cell growth and proliferation, escape from apoptosis, angiogenesis or lymphogenesis, or the mechanisms of cancer cell motility and invasion. In some aspects of the invention, expression of a biomarker is detected at the protein level using a biomarker-specific antibody or at the nucleic acid level using nucleic acid hybridization techniques. Methods for detecting ovarian cancer in patients are further disclosed herein. Kits for practicing the methods of the invention are further provided.
Compositions and methods for diagnosing high-grade cervical disease in a patient sample are provided. The compositions include novel monoclonal antibodies, and variants and fragments thereof, that specifically bind to MCM6 or MCM7. Monoclonal antibodies having the binding characteristics of an MCM6 or MCM7 antibody of the invention are further provided. Hybridoma cell lines that produce an MCM6 or MCM7 monoclonal antibody of the invention are also disclosed herein. The compositions find use in practicing methods for diagnosing high-grade cervical disease comprising detecting overexpression of MCM6, MCM7, or both MCM6 and MCM7 in a cervical sample from a patient. Kits for practicing the methods of the invention are further provided. Polypeptides comprising the amino acid sequence for an MCM6 or an MCM7 epitope and methods of using these polypeptides in the production of antibodies are also encompassed by the present invention.
C07K 14/47 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from animalsPeptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from humans from vertebrates from mammals
C07K 16/30 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
G01N 33/574 - ImmunoassayBiospecific binding assayMaterials therefor for cancer
41.
Apparatus and method for rapid microscopic image focusing having a movable objective
A method of capturing a focused image of a continuously moving slide/objective arrangement is provided. A frame grabber device is triggered to capture an image of the slide through an objective at a first focus level as the slide continuously moves laterally relative to the objective. Alternatingly with triggering the frame grabber device, the objective is triggered to move to a second focus level after capture of the image of the slide. The objective moves in discrete steps, oscillating between minimum and maximum focus levels. The frame grabber device is triggered at a frequency as the slide continuously moves laterally relative to the objective so multiple images at different focus levels overlap, whereby a slide portion is common to each. The image having the maximum contrast value within overlapping images represents an optimum focus level for the slide portion, and thus the focused image. Associated apparatuses and methods are also provided.
Methods for chromogen separation-based image analysis are provided, with such methods being directed to quantitative video-microscopy techniques in cellular biology and pathology applications.
G01N 33/48 - Biological material, e.g. blood, urineHaemocytometers
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
43.
METHODS OF CHROMOGEN SEPARATION-BASED IMAGE ANALYSIS
Methods for chromogen separation-based image analysis are provided, with such methods being directed to quantitative video-microscopy techniques in cellular biology and pathology applications.
Methods for chromogen separation-based image analysis are provided, with such methods being directed to quantitative video-microscopy techniques in cellular biology and pathology applications. Specifically, the invention relates to a method of determining optical density data for at least one dye staining a sample.
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
45.
Monoclonal antibodies and methods for their use in the detection of cervical disease
Compositions and methods for diagnosing high-grade cervical disease in a patient sample are provided. The compositions include novel monoclonal antibodies, and variants and fragments thereof, that specifically bind to MCM2. Monoclonal antibodies having the binding characteristics of an MCM2 antibody of the invention are further provided. Hybridoma cell lines that produce an MCM2 monoclonal antibody of the invention are also disclosed herein. The compositions find use in practicing methods for diagnosing high-grade cervical disease comprising detecting overexpression of MCM2 in a cervical sample from a patient. Kits for practicing the methods of the invention are further provided. Polypeptides comprising the amino acid sequence for an MCM2 epitope and methods of using these polypeptides in the production of antibodies are also encompassed by the present invention.
Methods and computer program products for evaluating and optimizing one or more markers for use in establishing a prognosis for a patient suffering from a disease are provided. More particularly, the methods include steps for systematically evaluating a number of features that may be extracted from an image of a body sample, such as a histological slide, that has been exposed to one or more biomarkers so as to establish a prognostic decision rule based on one or more of the extracted features such that the decision rule yields a prognosis that is optimally predictive of actual patient outcome. Thus, the methods and computer program products provided yield optimally predictive prognoses to assist clinicians in developing strategies for effective patient care management.
Methods and computer program products for evaluating and optimizing one or more markers for use in establishing a prognosis for a patient suffering from a disease are provided. More particularly, the methods include steps for systematically evaluating a number of features that may be extracted from an image of a body sample, such as a histological slide, that has been exposed to one or more biomarkers so as to establish a prognostic decision rule based on one or more of the extracted features such that the decision rule yields a prognosis that is optimally predictive of actual patient outcome. Thus, the methods and computer program products provided yield optimally predictive prognoses to assist clinicians in developing strategies for effective patient care management.
The present invention is directed to a pre-coated substrate, such as a slide, that is useful for immobilizing a sample. The invention is further provides methods of preparing such pre-coated substrates and methods of analyzing biological samples immobilized on such pre-coated substrate. The substrate is coated with a polycationic polymeric coating material specifically selected such that that coated substrate exhibits increased stability and prolonged shelf-life. Preferred polymeric coating materials include allylic or vinylic polymers having cationic groups thereon and having no more than a small percentage of peptidic monomeric linkages, particularly polydiallyldimethylammonium (PDDA).
G01N 31/00 - Investigating or analysing non-biological materials by the use of the chemical methods specified in the subgroupsApparatus specially adapted for such methods
G01N 33/00 - Investigating or analysing materials by specific methods not covered by groups
49.
POLYCATIONIC POLYMER COATINGS FOR IMMOBILIZING BIOLOGICAL SAMPLES
The present invention is directed to a pre-coated substrate, such as a slide, that is useful for immobilizing a sample. The invention is further provides methods of preparing such pre-coated substrates and methods of analyzing biological samples immobilized on such pre-coated substrate. The substrate is coated with a polycationic polymeric coating material specifically selected such that that coated substrate exhibits increased stability and prolonged shelf-life. Preferred polymeric coating materials include allylic or vinylic polymers having cationic groups thereon and having no more than a small percentage of peptidic monomeric linkages, particularly polydiallyldimethylammonium (PDDA).
Methods and compositions for identifying high-grade cervical disease in a patient sample are provided. The methods of the invention comprise detecting overexpression of at least one biomarker in a body sample, wherein the biomarker is selectively overexpressed in high-grade cervical disease. In particular claims, the body sample is a cervical smear or monolayer of cervical cells. The biomarkers of the invention include genes and proteins that are involved in cell cycle regulation, signal transduction, and DNA replication and transcription. In particular claims, the biomarker is an S-phase gene. In some aspects of the invention, overexpression of a biomarker of interest is detected at the protein level using biomarker-specific antibodies or at the nucleic acid level using nucleic acid hybridization techniques. Kits for practicing the methods of the invention are further provided.
01 - Chemical and biological materials for industrial, scientific and agricultural use
05 - Pharmaceutical, veterinary and sanitary products
10 - Medical apparatus and instruments
Goods & Services
Chemical diagnostic and testing reagents for scientific use. Pharmaceutical, veterinary and sanitary preparations; reagents, preservatives and staining fluids for medical, surgical and veterinary use; staining and colouring agents for medical, surgical use and veterinary use; general purpose reagents for clinical and medical use; products used to collect, prepare, and examine specimens from the human body which may he combined with or used in conjunction with appropriate analyte specific reagents and other general use reagents as part of a diagnostic test procedure or system constituting an in vitro diagnostic test, including control materials that may be used to ascertain the accuracy of a process or test system used to evaluate human specimens; reagents for medical use. Surgical, medical, and veterinary apparatus and instruments; medical apparatus and instruments for use in medical and scientific analysis and research; slides for medical and surgical use; mixing sticks and swabs for use with reagents and staining and colouring agents.
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
(1) Reagents for clinical or medical laboratory use to collect, prepare, and examine specimens from human body which may be combined with or used in conjunction with appropriate anolyte specific reagents and other general use reagents as part of a diagnostic test procedure or system constituting an in vitro diagnostic test, including control materials that may be used to ascertain the accuracy of a process or test system used to evaluate human specimens.
05 - Pharmaceutical, veterinary and sanitary products
09 - Scientific and electric apparatus and instruments
10 - Medical apparatus and instruments
Goods & Services
Reagents, preservatives and staining fluids for medical and veterinary purposes; reagents, preservatives and staining fluids for use in cancer diagnostic screening, staging and monitoring; reagents for use in medical and scientific analysis and detection; cancer staging and screening antibody tests; medical diagnostic tests, assays and reagents for use in medical analysis and detection; assays and kits comprised of various components and screening devices all for use in medical analysis including cancer screening. Scientific apparatus and instruments; chemical diagnostic and testing reagents for scientific use; computer imaging systems; computer software and hardware for use in medical and scientific analysis and research, cancer diagnostic screening, staging and monitoring. Medical apparatus and instruments for use in cancer diagnostic screening, staging and monitoring; imaging systems and components thereof for use in medical and scientific analysis and research, cancer diagnostic screening, staging and monitoring; testing reagents for medical use; cancer staging and screening antibody tests; medical test kits and apparatus for use in relation to cancer staging and diagnosis and the screening of anti-bodies; kits and assay kits and components thereof for use in medical and scientific analysis and cancer screening; medical and scientific imaging systems including hardware, software, and other components for use in medical and scientific analysis and research including diagnostic screening, prognosis and monitoring.
09 - Scientific and electric apparatus and instruments
10 - Medical apparatus and instruments
Goods & Services
(1) Computer hardware and software for use in conventional and thin layer pap smear image diagnostics; computer hardware and software for diagnostic imaging using automated cell location; computer hardware and software for use in data and image processing in the field of computer-aided medical microscopy; video cameras for use in the field of computer-aided medical microscopy; manual and automated microscopes for use in the field of computer-aided medical microscopy
(2) Medical apparatus, namely, a device for diagnostic imaging of conventional and thin layer pap smears.
05 - Pharmaceutical, veterinary and sanitary products
10 - Medical apparatus and instruments
Goods & Services
Consumable test kits comprised of reagents, sold as a unit with collection devices, microscope slides, centrifuge tubes, syringing devices, settling chambers and disposable pipette tips for use in preparing and screening cytological samples in scientific, medical or clinical procedures. Consumable test kits comprised of collection devices, syringing devices, settling chambers and disposable pipette tips sold as a unit with reagents, microscope slides and centrifuge tubes for use in preparing and screening cytological samples in scientific, medical or clinical procedures; medical apparatus for diagnostic imaging of conventional and thin layer Pap smears comprising computer hardware and software.
05 - Pharmaceutical, veterinary and sanitary products
09 - Scientific and electric apparatus and instruments
Goods & Services
Reagents to preserve and prepare cells and small tissue samples collected from human sources for clinical presentation and evaluation. Automated laboratory robot and related operating software, accessories and consumables which prepare liquid-based thin-layer cellular samples from a cell suspension for use in medical, clinical and scientific procedures, and devices for use therewith, namely, vials, tubes, disposable kits, pipettes, settling chambers and slides.
09 - Scientific and electric apparatus and instruments
10 - Medical apparatus and instruments
Goods & Services
Computer hardware and software for use in conventional and thin layer Pap smear image diagnostics, computer hardware and software for diagnostic imaging using automated cell location, computer hardware and software for use in data and image processing in the field of computer-aided medical microscopy; video cameras for use in the field of computer-aided medical microscopy, manual and automated microscopes for use in the field of computer-aided medical microscopy. Medical apparatus, namely a device for diagnostic imaging of conventional and thin layer Pap smears.
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Reagents and disposables used to obtain, preserve and prepare cells and small tissue samples collected from human sources for clinical presentation and evaluation.
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
(1) Medical reagents, namely preservative liquids, used to obtain, preserve and prepare cells and small tissue samples collected from human sources for clinical presentation and evaluation.
05 - Pharmaceutical, veterinary and sanitary products
09 - Scientific and electric apparatus and instruments
Goods & Services
(1) Reagents to preserve and prepare cells and small tissue samples collected from human sources for clinical presentation and evaluation.
(2) Automated laboratory robot used in the preparation of liquid-based, thin layer cellular samples from a cell suspension for use in medical, clinical and scientific procedures; accessories for use with automated laboratory robots namely, keyboards, monitors, and central processing units; computer operating software namely, an operating program used in conjunction with an automated laboratory robot; apparatus and accessories used with automated laboratory robots namely, vials, tubes, disposable kits, pipettes, vial racks, settling chambers and slides.
05 - Pharmaceutical, veterinary and sanitary products
10 - Medical apparatus and instruments
42 - Scientific, technological and industrial services, research and design
Goods & Services
Consumable test kits comprised of reagents, sold as a unit with collection devices, microscope slides, centrifuge tubes, syringing devices, settling chambers and disposable pipette tips for use in preparing and screening cytological samples in scientific, medical or clinical procedures. Consumable test kits comprised of collection devices, syringing devices, settling chambers and disposable pipette tips sold as a unit with reagents, microscope slides and centrifuge tubes for use in preparing and screening cytological samples in scientific, medical or clinical procedures; medical apparatus for diagnostic imaging of conventional and thin layer Pap smears comprising computer hardware and software. Research services, namely developing and commercializing molecular diagnostic and pharmagenomic tests, genetic marker technologies and immunoassay development for cancer detection and prevention.
05 - Pharmaceutical, veterinary and sanitary products
09 - Scientific and electric apparatus and instruments
Goods & Services
reagents to preserve and prepare cells and small tissue samples collected from human sources for clinical presentation and evaluation automated laboratory robot and related operating software, accessories and consumables which prepares liquid-based, thin layer cellular samples from a cell suspension for use in medical, clinical and scientific procedures and devices for use therewith, namely vials, tubes, disposable kits, pipettes, settling chambers and slides
MEDICAL APPARATUS, NAMELY, A DEVICE FOR DIAGNOSTIC IMAGING OF CONVENTIONAL AND THIN LAYER PAP SMEARS; COMPUTER HARDWARE AND SOFTWARE FOR USE IN CONVENTIONAL AND THIN LAYER PAP SMEAR IMAGE DIAGNOSTICS; COMPUTER HARDWARE AND SOFTWARE FOR DIAGNOSTIC IMAGING USING AUTOMATED CELL LOCATION; COMPUTER HARDWARE AND SOFTWARE FOR USE IN DATA AND IMAGE PROCESSING IN THE FIELD OF COMPUTER-AIDED MEDICAL MICROSCOPY; VIDEO CAMERAS FOR USE IN THE FIELD OF COMPUTER-AIDED MEDICAL MICROSCOPY; MANUAL AND AUTOMATED MICROSCOPES FOR USE IN THE FIELD OF COMPUTER-AIDED MEDICAL MICROSCOPY
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Medical reagents, namely preservative liquids, used to obtain, preserve and prepare cells and small tissue samples collected from human sources for clinical presentation and evaluation
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
family of clinical reagents used to preserve and prepare cells and small tissue samples collected from human sources for clinical presentation and evaluation
09 - Scientific and electric apparatus and instruments
10 - Medical apparatus and instruments
Goods & Services
device for the preparation of cytology thin-layer slides for scientific use device for the preparation of cytology thin-layer slides for medical use and for clinical medical use
05 - Pharmaceutical, veterinary and sanitary products
09 - Scientific and electric apparatus and instruments
Goods & Services
Consumable test kits comprised of reagents, microscopic slides, centrifuge tubes, syringing devices, steeling chambers and disposable pipette tips, sold as a unit in preparing and screening cytological samples in clinical or medical laboratory procedures Consumable test kits comprised of microscope slides, centrifuge tubes, syringing devices, steeling chambers and disposable pipette tips, sold as a unit or for use in preparing and screening cytological samples in scientific procedures
09 - Scientific and electric apparatus and instruments
Goods & Services
robotic laboratory sample processors used to manufacture cytologic preparations, computer hardware, computer software for use in data and image processing in the field of computer-aided medical microscopy; cameras and microscopes
