Abstract: The invention provides compositions and methods for identifying a gender-specific cancer patient suitable for treatment with various treatment regimens available to cancer patients. After determining if a patient is suitable for therapy, the invention also provides methods for treating these patients.

Abstract: Compositions and methods that use the body's natural secretory immune system in a new way against steroid hormone responsive tumors of the breast and prostate, as well as other glandular/mucus epithelial tissues such as colon, ovary, endometrium, kidney, bladder, stomach, pancreas and secretory pituitary gland are provided. Also provided are new ways of identifying carcinogenic, or potentially carcinogenic, bacteria in a tissue or body fluid to provide better anti-cancer therapies and preventatives than have been available previously.

Abstract: The present invention demonstrates that the diagnosis and prediction of clinical behavior in patients with hematologic malignancies, such as leukemia, can be accomplished by analysis of proteins present in a plasma sample. Thus, in particular embodiments the present invention uses plasma to create a diagnostic or prognostic protein profile of a hematologic malignancy comprising collecting plasma samples from a population of patients with hematologic malignancies; generating protein spectra from the plasma samples with or without fractionation; comparing the protein spectra with clinical data; and identifying protein markers in the plasma samples that correlate with the clinical data. Protein markers identified by this approach can then be used to create a protein profile that can be used to diagnose the hematologic malignancy or determine the prognosis of the hematologic malignancy. Potentially these specific proteins can be identified and targeted in the therapy of these malignancies.

Abstract: Systems and methods for enhancing fluorescent detection of target molecules in a test sample are for use with an irradiating device. First fluorophores are provided for absorption of EMF radiation, and emission of a first signal. Second fluorophores are provided for partial absorption of the first signal, and emission of a second signal distinguishable from the first signal. The fluorophores are combined with the test sample, and secured to the target molecules and relative to one another. After the first fluorophores receive the EMF radiation from the irradiating device, the first signal is detected, together with the second spectral signal if the target molecules are present in the test sample.

Abstract: The present invention is directed to methods of detecting viable epithelial cells in a sample. The method includes isolating the sample comprising cells from a patient and culturing the cells for a time sufficient for an epithelial cell-specific marker to be released from the cells. The marker includes a substantially full-length cytokeratin. The method further includes detecting the released marker. Detection of the marker indicates the presence of disseminated epithelial cells. Methods are also directed to identifying disseminated epithelial tumor cells.

Abstract: The present invention provides a blood analyzer and a blood analyzing method capable of obtaining information regarding B lymphocytes and T lymphocytes without using a fluorescence-labeled antibody. The blood analyzer of the present invention includes a blood specimen supplying portion, a sample preparation portion that prepares a measurement sample without using a fluorescence-labeled antibody by mixing a blood specimen supplied from the blood specimen supplying portion, a hemolyzing agent, and a fluorescent dye that stains nucleic acid, a light source, a first detector that detects fluorescence, a second detector that detects scattered light, and information processing portion that classifies lymphocytes based on the intensity of fluorescence and scattered light, and based on the fluorescence intensity of the classified lymphocytes, obtains information regarding B-lymphocytes and T-lymphocytes.

Abstract: A novel biomarker for use in lung cancer diagnosis is provided.

Abstract: This invention relates to products and methods for treating cancer and for diagnosing tumorigenicity and other diseases associated with alteration in GP88 expression or action. Antagonists to an 88 KDa autocrine growth and tumorigenicity stimulator are provided which inhibit its expression or biological activity. The antagonists include antisense oligonucleotides and antibodies.

Abstract: Described are methods for assessing recurrence status in a breast cancer patient that include assaying a biological sample from the patient for a level of a biomarker selected from such as S100? or HOX-C1I, where positive detection of one or both of the biomarkers indicates a positive recurrence status. The method can be used for prognosis of poor disease free survival in a breast cancer patient, where positive detection of one or both of the biomarkers indicates poor disease survival. The method may also be used for diagnosis of recurrence, where positive detection of circulating S100? is a diagnostic variable of recurrence. The method of diagnosis is carried out on a patient who is undergoing first line therapy and/or a patient who has had surgery to remove a primary breast tumour.

Abstract: This invention is directed, inter alia, to methods and kits for rapid, easy and cost-effective methods of breast cancer prediction and diagnosis in inter alia, blood samples.

Abstract: The present invention relates to identification of a set of proteins, which elicit an autoantibody response in patients with cancer of gingivo-buccal complex. Systematic comparisons of serum samples from clinically normal individuals and from patients with cancer of gingivo-buccal complex has revealed significant differences in the presence of autoantibodies in sera against cellular antigens present in a cancer cell line. The autoantibody response to a single or combination of these protein antigens serves as a novel marker and can be utilized for screening, early detection, prognosis, and potential target for therapy. The invention also provides for the use of the identified protein antigens in immunoassays designed to detect the presence of serum antibodies to the specific protein antigens in sera from individuals that harbor such antibodies. The invention also relates to the use of the identified antigens as immunogens for stimulation of an immune response in patients expressing such protein antigens.

Abstract: A device and method for extending the useful life of a bulk liquid used in an automated clinical analyzer. Air from the atmosphere surrounding the automated clinical analyzer that displaces the bulk liquid consumed from a container is routed through a gas scrubber in order to remove or at least reduce the quantity of at least one contaminant present in that air. The gas scrubber is positioned between the bulk liquid in the container and the atmosphere surrounding the container. The gas scrubber contains a reagent that is capable of reacting with a contaminant in the atmosphere, whereby a required characteristic(s) of the bulk liquid does (do) not change excessively prior to the date that the bulk liquid is consumed. For example, if the contaminant is carbon dioxide, and the required characteristic of the bulk liquid is the level of pH of the bulk liquid, the reagent in the gas scrubber prevents the level of pH of the bulk liquid from changing excessively prior to the date that the bulk liquid is consumed.

Abstract: The present invention provides methods of detecting ovarian cancer using biomarkers.

Abstract: The present invention provides a system containing an array of chemically sensitive sensors based on coated single walled carbon nanotubes, for measuring volatile organic compounds indicative of renal failure. Methods of breath analysis for diagnosing chronic, acute and end-stage renal failure are disclosed.

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: A method for detecting a predisposition to breast cancer in a subject is provided. The method includes detecting in a biological sample from the subject one or more polymorphisms in the sequence of CD44 gene. The presence of one or more polymorphisms in the sequence of CD44 gene indicates that the subject has a predisposition for developing breast cancer.

Abstract: A novel gene 254P1D6B and its encoded protein, and variants thereof, are described wherein 254P1D6B exhibits tissue specific expression in normal adult tissue, and is aberrantly expressed in the cancers listed in Table I. Consequently, 254P1D6B provides a diagnostic, prognostic, prophylactic and/or therapeutic target for cancer. The 254P1D6B gene or fragment thereof, or its encoded protein, or variants thereof, or a fragment thereof, can be used to elicit a humoral or cellular immune response; antibodies or T cells reactive with 254P1D6B can be used in active or passive immunization.

Abstract: The present invention relates to an assay device and a method for using such for the quantitative determination of an analyte, based on a test strip, which contains a porous test membrane allowing for capillary flow of the analyte and complexes of the analyte, a porous upstream membrane in fluid connection with the test membrane and a porous downstream membrane in fluid connection with the test membrane, wherein the test membrane contains a test site having immobilized thereon a ligand capable of reacting with the analyte and binding such to the test site, and two standard band sites having immobilized thereon known high and low concentrations of a calibrator agent capable of reacting with a label conjugate and binding such to the standard sites, wherein the upstream membrane has a site for the application of a sample to be analyzed, and has a site downstream from the sample application site for depositing label conjugates capable of reacting with the analyte and label conjugates capable of reacting with the

Abstract: A method for the in vitro diagnosis of colorectal cancer by determining the presence of the I-Plastin tumor marker in a biological sample taken from a patient suspected of having colorectal cancer. Said method can be used for early diagnosis, screening, therapeutic follow-up and prognosis, and also for relapse diagnosis in relation to colorectal cancer.

Abstract: A method for determining whether early stage cancer is present in a subject comprises detecting the expression level of GASP-1 in the subject by detecting the amount of GASP-1 peptide fragments present in a biological sample of the subject. Because cancer can be detected at an early stage, therapeutic targeting may be initiated before cancer reaches late stage (e.g., before the development of overt symptoms). A method for treating early stage cancer in a subject comprises administering to the subject an effective amount of a GASP-1 inhibitor to inhibit the progression of early stage cancer to late stage cancer. A Competitive ELISA capable of detecting GASP-1 peptide fragments at a concentration of less than 1 ng/ml was developed.

Abstract: The invention provides methods for predicting or determining the response of a mammalian tumor to a chemotherapeutic agent and for treating a mammalian tumor comprising detecting and quantifying the SPARC protein or RNA in a sample isolated from the mammal. The invention further provides kit for predicting the response of a mammalian tumor to a chemotherapeutic agent, comprising a means for the isolation of protein or RNA from the tumor, a SPARC protein or RNA detection and quantification means, control RNAs, and rules for predicting the response of the tumor based on the level of SPARC protein or RNA in tumor.

Abstract: The invention provides methods for predicting or determining the response of a mammalian tumor to a chemotherapeutic agent and for treating a mammalian tumor comprising detecting and quantifying the SPARC protein or RNA in a sample isolated from the mammal. The invention further provides kit for predicting the response of a mammalian tumor to a chemotherapeutic agent, comprising a means for the isolation of protein or RNA from the tumor, a SPARC protein or RNA detection and quantification means, control RNAs, and rules for predicting the response of the tumor based on the level of SPARC protein or RNA in tumor.

Abstract: The invention relates to thrombospondin fragments found in plasma, their use or use of portions thereof in diagnostic methods, as method calibrators, method indicators, and as immunogens, and as analytes for methods with substantial clinical utility; and their detection in plasma or other bodily fluids for purpose of diagnostic methods, especially for cancer.

Abstract: The invention provides kits and methods for detecting or monitoring the number of cells in sample. The cell comprises a cell surface associated protein (CSAP) comprising a cytoplasmic (cytosolic) and an extracellular (ecto) domain. The kit comprises: (i) a chromatographic device; and (ii) a CSAP-binding agent. The method comprises: (i) optionally contacting the sample with an agent capable of lysing or permeabilizing CSAP bearing cells; (ii) contacting the sample with a CSAP-binding agent that binds to the cytoplasmic domain of the CSAP; and (iii) directly or indirectly evaluating the level or presence of bound CSAP in the sample.

Abstract: A spectral characteristic calculation device stores a plurality of conversion matrices used to calculate the spectral characteristic values based on brightness values of a digital color image, and a plurality of pieces of brightness value information respectively corresponding to a plurality of sample groups. The plurality of conversion matrices are generated based on the sample color image information contained in the plurality of sample groups, respectively. An evaluating unit is configured to evaluate similarity of brightness value information of the target data with respect to each of the plurality of pieces of brightness value information of the plurality of sample groups. A conversion matrix corresponding to the sample group that is evaluated to have the highest similarity is selected as the conversion matrix. Then, a calculating unit calculates the spectral characteristic values of the target data using the conversion matrix selected by the selecting unit.

Abstract: Novel immuno-interactive fragments of the ?C portion of a mammalian inhibin ? subunit, together with their variants and derivatives, produce antigen-binding molecules that are interactive with the ?C portion, and which are chemically well defined and which can be produced in commercially significant quantities. The antigen-binding molecules of the invention can be used for the detection of a mammalian inhibin and for the treatment and/or prevention of conditions associated with aberrant levels of a mammalian inhibin.

Abstract: The present invention demonstrates the differential sensitivity of PBLs from lung cancer patients and healthy controls to NNK-induced genetic damage. The data provide convincing evidence that the preferred CBMN assay is a robust test for detection of this sensitivity and yields results that are a good predictor of, for example, lung cancer risk. The simplicity, rapidity, and sensitivity of the CBMN test make it a valuable tool for screening and, for example, prioritizing potential cases for early detection of the disease.

Abstract: This invention relates, e.g., to a method for detecting the presence of lymph node metastases in a subject having papillary thyroid carcinoma (PTC), comprising measuring in a sample from the subject the amount of expression (e.g., the amount of protein, or the amount of mRNA encoding the protein) of one or more of the following proteins: (a) LIMD2, and/or (b) PTPRC, and/or (c) LTB, and/or (d) CD48, and/or (e) ABCC3, wherein a significant amount of over-expression of one or more of protein(s) (a)-(e), compared to the baseline value, indicates that lymph node metastases are likely to be present in the subject.

Abstract: The present invention provides a method for detecting and grading benign and malignant tumors using at least one sensor of conductive nanoparticles capped with an organic coating in conjunction with a learning and pattern recognition algorithm. The method utilizes a plurality of response induced parameters to obtain improved sensitivity and selectivity for diagnosis, prognosis, monitoring and staging various types of cancers, or for identifying or grading benign or malignant tumors.

Abstract: The present invention provides a novel cancer-associated antigen that can be used in the treatment and diagnosis of cancer. Further, the invention provides amino acid and nucleic acid sequence of the novel antigen, binding proteins, and immunoconjugates. The invention also relates to diagnostic and therapeutic methods and kits.

Abstract: The present invention relates to a method of diagnosis and therapy of cancers expressing the HER2 receptor. The invention provides antibodies or fragments thereof that recognizes an epitope of a HER2 receptor truncated form, said epitope being defined by a sequence included in SEQ ID NO: 2. The invention also provides a method of cancer diagnosis, which comprises the detection of the presence of the HER2 receptor truncated form consisting of the amino acid sequence SEQ ID NO: 1 in a patient sample.

Abstract: The present invention relates to the use of proteins that are differentially expressed in tumor associated stromal cells, as compared to normal stromal, as biomolecular targets for tumor treatment therapies. The present invention also provides compounds and pharmaceutically acceptable compositions for administration in the methods of the invention.

Abstract: The present invention relates to methods and kits for diagnosing, ascertaining the clinical course of myelodysplastic syndrome (MDS) and ascertaining response to a therapy regimen of myelodysplastic syndrome. Specifically the invention provides methods and kits useful in the diagnosis and determination of clinical parameters associated with MDS based on surface markers unique to MDS.

Abstract: The present invention provides novel markers for diagnosing pancreatic cancer, and methods for determining if a subject has pancreatic cancer utilizing the markers, etc. The methods involve comparing mass-spectrometric peaks of certain sugar chains, obtained from patients' blood and determining if there is a significant decrease in peak intensity, compared with corresponding peaks from patients without pancreatic cancer.

Abstract: The present invention relates to a method for improved diagnosis of dysplasias based on simultaneous detection of INK4a gene products and at least one marker for cell proliferation. Particularly the present invention provides a method for discriminating dysplastic cells over-expressing INK4a gene products from cells over-expressing INK4a gene products without being dysplastic by detection of a marker suitable for characterizing the proliferation properties of the respective cell. The characterization of the proliferation properties may comprise the detection of a marker or a set of markers characteristic for active cell proliferation and/or a marker or a set of markers characteristic for retarded or ceased cell proliferation. The method presented herein thus enables for a specific diagnosis of dysplasias in histological and cytological specimens.

Abstract: A method for detecting a predisposition to breast cancer in a subject is provided. The method includes detecting in a biological sample from the subject one or more polymorphisms in the sequence of CD44 gene. The presence of one or more polymorphisms in the sequence of CD44 gene indicates that the subject has a predisposition for developing breast cancer.

Abstract: Disclosed in a method of detecting cancer using IL-27 receptors. IL27R is a cytokine receptor identified as a novel oncogene from an acute myeloid leukemia patient. It induces cancer-like properties when expressed in cells and can activate a protein that causes various myeloid cell disorders. The data show cytokine receptors play unappreciated roles in mediating activation of signaling pathways in circulatory system cancers. Also method of screening for novel oncogenes using a functional, approach is disclosed using cytokine-dependent cells to screen for transforming events.

Abstract: The invention concerns anti-clusterin oligoclonal antibodies able to recognize and bind in a selective and specific way antigenic epitopes of clusterin isoforms to be used in tumors diagnosis and in the prediction of their malignancy grade, diagnostic method and related kits.

Abstract: A cancer cell separating apparatus includes: a flow channel including an antibody fixation area having antibodies which bind specifically to cancer cells fixed thereon, wherein the cancer cells and non-cancer cells are separated using a difference in velocity of movement between the cancer cells and the non-cancer cells in cell slurry introduced into the flow channel.

Abstract: Provided is a monoclonal antibody, or an antigen binding fragment thereof, which binds specifically to an epitope within the sequence KPGAKKDTKDSRPKL (Sequence ID No. 2) of AGR2. Such monoclonal antibodies are of prognostic and diagnostic utility in the investigation of cancer, particularly metastatic cancer. The antibodies described may also be used in prognosis or diagnosis of inflammatory diseases. Also provided are kits and solid supports comprising such antibodies, as well as the therapeutic use of antibodies of the invention.

Abstract: The screening method for an anticancer drug comprises selecting a compound which blocks the kinase activity of TNIK, or blocks the combination of TNIK with ?-catenin/TC4 transcription complex.

Abstract: Provided herein is technology relating to isolating nucleic acids. In particular, the technology relates to methods and kits for extracting nucleic acids from problematic samples such as stool.

Abstract: The present invention provides an approach for the simultaneous determination of the activation states of a plurality of proteins in single cells. This approach permits the rapid detection of heterogeneity in a complex cell population based on activation states, and the identification of cellular subsets that exhibit correlated changes in activation within the cell population. Moreover, this approach allows the correlation of cellular activities or properties. In addition, the use of potentiators of cellular activation allows for characterization of such pathways and cell populations.

Abstract: The present invention relates to novel methods and compositions for detection and isolation of cancer cells with metastatic potential. The invention further relates to assays for measuring the metastatic potential of such cancer cells and drug screening assays for the identification of agents having anti-metastatic potential. The present invention further provides methods and compositions for inhibiting the metastatic potential of cancer cells by modulating the activity of serine integral membrane proteases [(SIMP) consisting of seprase and dipetidyl peptidase IV (DPPIV)] expressed on the surface of metastasizing cancer cells.

Abstract: Human PGD genes are identified as modulators of the PTEN pathway, and thus are therapeutic targets for disorders associated with defective PTEN function. Methods for identifying modulators of PTEN, comprising screening for agents that modulate the activity of PGD are provided.

Abstract: The present invention provides a method for determining a response of a mammalian subject having melanoma tumor cells to treatment with a melanoma inhibitory agent. In one aspect, the method comprises (a) determining a first concentration of melanoma inhibitory activity protein (MIA) in a first biological sample taken from the mammalian subject before treatment with the melanoma inhibitory agent; (b) determining a second concentration of MIA in a second biological sample from the mammalian subject taken after treatment with the melanoma inhibitory agent; and (c) comparing the first and second concentrations of MIA, wherein a decrease in the second concentration of MIA measured in the second biological sample as compared to the first concentration of MIA measured in the first biological sample indicates a positive response to the treatment with the melanoma inhibitory agent.

Abstract: The present invention relates to a method for diagnosing cancer using information on the aberrant glycosylation of a glycoprotein. More precisely, the present invention relates to a cancer diagnosis peptide marker, which is screened by: a step of separating, using a lectin, a glycoprotein which is aberrantly glycosylated in accordance with the occurrence of cancer; and a step of selecting a hydrolyzed peptide marker derived from the aberrantly glycosylated glycoprotein by observing the quantitative changes in the separated glycoprotein. The present invention also relates to a method for diagnosing cancer using the peptide marker as an agent.

Abstract: The disclosure provides, among other things, molecular markers for categorizing the neoplastic state of a patient, methods for using the molecular markers in diagnostic tests, nucleic acid and amino acid sequences related to the molecular markers, reagents for detection of molecular markers, and methods for identifying candidate molecular markers in highly parallel gene expression data.

Abstract: The invention relates to a simple screening test for neoplasia, a precancerous condition, or cancer of the breast. A method is described whereby a breast cancer marker is detected in breast fluid. In a particular embodiment, the method involves treating samples of breast fluids with an aldehyde detecting reagent without any prewashing. The appearance in breast fluids of a marker that is detected by an aldehyde detecting reagent, such as a Schiff's reagent, correlates very well with the disease status of the breast cancer subjects from which the fluids were obtained. Screening test kits are also provided.

Abstract: The invention describes SAGE (sdph3.10) and sdp3.5 tumor associated nucleic acids, including fragments and biologically functional variants thereof. Also included are polypeptides and fragments thereof encoded by such nucleic acid molecules, and antibodies relating thereto. Methods and products also are provided for diagnosing and treating conditions characterized by expression of a sdph3.10 and/or sdp3.5 gene product.