Abstract: A system for automatically processing a biological specimen is provided that includes an elevator comprising a plurality of shelves configured to receive a plurality of sample trays. The trays may comprise a plurality of sample containers containing a sample and having a plurality of respective caps engaged therewith. The trays may further include a plurality of centrifuge tube racks each containing a plurality of centrifuge tubes. The system may include a first transport mechanism, a second transport mechanism and a third transport mechanism. The system may include a chain-of-custody device configured to read identifiers on each of the containers. The system may also include a pipetting device configured to remove a portion from the sample containers and dispense the sample into the centrifuge tubes.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: A method of re-locating an object in a sample is provided for a previously-scanned slide having determined objects each with corresponding stored coordinates and a stored image, the objects being mapped relative to each other. The slide is positioned on a microscope stage, stored images of the objects are visually displayed, and a target object is selected. The slide is moved to an estimated coordinate position, corresponding to the coordinates of the target object, and a field-of-view image of the sample is captured for comparison to the stored image of the target. If the target is in the image, an offset between actual coordinates of the located target and the stored coordinates of the corresponding object is determined. The slide is then moved, via the stage, from the estimated coordinate position, according to the offset, to center the target in the image. Associated systems and methods are also provided.

Abstract: 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.

Abstract: 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 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.

Abstract: 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 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.

Abstract: A method of determining an amount of at least one molecular species in a sample from an image of the sample captured by an image acquisition device is provided, each molecular species being indicated by a dye. A dye space representation of a plurality of dyes is formed by orthogonally adding the correspondence tables of the dyes, each correspondence table having a plurality of normalized RGB triplets and incrementally extending from 0% to 100% transmittance. The dye space representation has one dimension for each dye and provides a reference model for a combination of the plurality of dyes. Each pixel of an image of the sample stained with the combination of the plurality of dyes is compared to the reference model, each pixel having a color defined by an RGB triplet, so as to determine an optimal combination of normalized RGB triplets from the respective correspondence tables of the dyes producing the color of the respective pixel.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: Methods and compositions for evaluating the prognosis of a breast cancer patient, particularly an early-stage breast cancer patient, are provided. The methods of the invention comprise detecting expression of at least one, more particularly at least two, biomarker(s) in a body sample, wherein overexpression of the biomarker or a combination of biomarkers is indicative of breast cancer prognosis. In some embodiments, the body sample is a breast tissue sample, particularly a primary breast tumor sample. The biomarkers of the invention are proteins and/or genes whose overexpression is indicative of either a good or bad cancer prognosis. Biomarkers of interest include proteins and genes involved in cell cycle regulation, DNA replication, transcription, signal transduction, cell proliferation, invasion, proteolysis, or metastasis.