Abstract: The invention discloses the use of a new cell growth related peptide. More precisely, the invention serves as a marker for cell proliferation. The marker is a peptide which is an exposed part of a cellular enzyme. This peptide is as well particularly useful as an aid in production of highly selective reactive molecules. The peptide is a part of thymidine kinase TK1 and has the sequence of SEQ ID NO: 1 or SEQ ID NO: 2.

Abstract: The present invention relates to DNA sequences from regions of copy number change on chromosome 20. The sequences can be used in hybridization methods for the identification of chromosomal abnormalities associated with various diseases.

Abstract: A method of detecting malignant or pre-malignant conditions of the cervix, and test kits therefor, involves selecting a fraction of a cervical cell sample consisting predominantly of epithelial cells and determining characteristics indicative of the malignant or pre-malignant conditions therein.

Abstract: The present invention relates to materials and methods for diagnosing breast cancer in humans. It is based, at least in part, on the discovery that a substantial percentage of human breast cancer tissue samples contained nucleic acid sequences corresponding to a portion of the mouse mammary tumor virus env gene. In contrast, such sequences were absent in almost all other human tissues tested.

Abstract: Methods and kits for diagnosing the presence of and prognosing the appearance of tissue remodelling-associated conditions, involving the presence of enzymes in a biological sample, are disclosed. In particular, the method pertains to diagnosing the presence of or prognosing appearance of cancer, metastatic cancer, and obstructive and degenerative conditions.

Abstract: Disclosed is a composition for the site-specific detection of gastrointestinal damage containing (a) a first disaccharide that does not degrade in the colon, small intestine or stomach; (b) a second disaccharide that degrades in the colon but does not degrade in the small intestine or stomach; and (c) a third disaccharide that degrades to its monosaccharides in the small intestine and not in the stomach. A method for the site-specific detection of gastrointestinal damage employing the composition of the invention is also disclosed.

Abstract: A method for screening individuals at risk for prostate cancer progression is disclosed. The method is useful for evaluating cells from patients at risk for recurrence of prostate cancer following surgery for prostate cancer. Specifically, the method uses specific Markovian nuclear texture factors, alone or in combination with other biomarkers, to determine whether the cancer will progress or lose organ confinement. In addition, methods of predicting the development of fatal metastatic disease by statistical analysis of selected biomarkers is also disclosed. The invention also contemplates a method that uses a neural network to analyze and interpret cell morphology data. Utilizing Markovian factors and other biomarkers as parameters, the network is first trained with a sets of cell data from known progressors and known non-progressors. The trained network is then used to predict prostate cancer progression in patient samples.

Abstract: A method of determining intracellular levels of water-soluble and fat-soluble antioxidants. Peripheral blood mononuclear cell lysates are prepared from an individual and analyzed by HPLC, either directly or after extraction with organic solvents to extract fat-soluble antioxidants. The levels of antioxidants are compared to normal levels as an indication of the overall oxidative health of the individual.

Abstract: The use of a phycobiliprotein-linker peptide complex as a fluorescent tracer in a fluorescent method of detecting and/or determining an analyte in a medium in which it may be present, is disclosed. Fluorescent conjugates consisting of said complex covalently bonded to one of the elements of a ligand/receptor specific binding pair, are also disclosed.

Abstract: Methods of screening for or treating cancer are disclosed. The screening methods are based on the detection of an antigen, or a nucleic acid molecule encoding the antigen, found by the present invention to be associated with the presence of cancer. Preferred embodiments of the methods include detection of the antigen based on immunological properties, physical properties, enzymatic properties and combinations thereof, or detection of a nucleic acid molecule encoding the antigen based on nucleic acid amplification.

Abstract: Novel hybridoma cell lines producing monoclonal antibodies reactive with purified mucin antigens from normal and tumor sources are generated using mucins, including purified mucins from tumor sources. Epitopes on mucin antigens from normal and tumor sources are demonstrated to be distinct, using these new antibodies. The antibodies may be useful alone or in combination, in the diagnosis and treatment of cancer including malignancies of the breast and lung.

Abstract: This invention provides a method for preserving cells which comprises the steps of (a) suspending cells in a physiologically-acceptable, isotonic medium; and (b) fixing the cells so suspended at a temperature of less than about 10.degree. C. under sufficiently hypertonic conditions so as to disperse the cells in a single, unagglutinated state, thereby preserving cells. This invention also provides a method for detecting cells separated from a sample which have been preserved according to the aforementioned method. This invention also provides a method for visualizing cells. Also provided is a method for detecting a metabolic process in cells present in a sample. This invention also provides a method for detecting the presence of rare cells in a sample which specifically possess on their surfaces a moiety recognized by a known ligand comprising preserving cells separated from the sample according to the aforementioned method for preserving cells.

Abstract: Improved methods for the diagnosis and treatment of cancer which involve the targeting of slow-growing, relatively mutationally-spared cancer stemline are provided. These methods are an improvement over previous cancer detection and therapeutic methods because they provide for very early cancer detection and treatment and reduce the likelihood of clinical relapse after treatment.

Abstract: The present invention relates to novel methods and devices for detecting non-complexed prostate specific antigen (free PSA), which is used in conjunction with total PSA tests to identify patients having either benign prostatic diseases (BPD), such as benign prostatic hyperplasia, prostatitis, or glandular atrophy or prostatic adenocarcinoma (CAP). In a biological sample, one can find not only free PSA, but also prsotate specific antigen (PSA) which has formed a complex with .alpha.1-antichymotrypsin (ACT). The present invention removes complexed PSA (PSA-ACT) from a fluid sample, thereby removing any possible interference due to binding of complexed PSA to an allegedly free PSA specific antibody in an immunoassay for free PSA.

Abstract: A method of determining the severity of prostatic cancer includes measuring the level of amplification of the HER-2/neu gene in a sample of prostate tissue by fluorescence in-situ hybridization and comparing the measured level of amplification of the HER-2/neu gene in the sample with the level of HER-2/neu gene in normal prostate tissue. A method for determining treatment for a patient afflicted with prostate cancer includes determining whether the number of copies of HER-2/neu gene in prostate cells from the patient exceeds four by using fluorescence in-situ hybridization and aggressively treating such patient having prostate cells with five or more copies of the HER-2/neu gene.

Abstract: A method for screening individuals at risk for the loss of organ confinement in prostate cancer is disclosed. The method is useful for evaluating cells from patients at risk for recurrence of prostate cancer following surgery for prostate cancer. Specifically, the method uses specific Markovian nuclear texture features, alone or in combination with other biomarkers, to determine whether the cancer will progress or lose organ confinement. In addition, methods of predicting the development of fatal metastatic disease by statistical analysis of selected biomarkers is also disclosed. The invention also contemplates a method that uses a neural network to analyze and interpret cell morphology data. Utilizing Markovian factors and other biomarkers as parameters, the network is first trained with a sets of cell data from known progressors and known non-progressors. The trained network is then used to predict the loss of organ confinement by evaluating patient samples.

Abstract: Monoclonal receptors raised to immunogenic polypeptides whose amino acid residue sequences correspond to sequences of oncoprotein ligands are disclosed, as are method for the production of those receptors and products and methods that utilize them. The monoclonal receptors bind both to the oncoprotein ligand to a portion of which the polypeptide corresponds in sequence, and to the immunogenic polypeptide to which the receptors were raised.

Abstract: This invention features methods for characterizing antigenic reactivity of biological samples by contacting a biological sample with two or a plurality of monoclonal receptor molecules raised to an immunogen containing a polypeptide of about 7 to about 40 amino acid residues and comparing the ensuing reaction pattern with a pattern generated with a known biological sample.

Abstract: Polynucleotide and polypeptide sequences encoding a novel tumor suppressor gene, DPC4, are provided. Also included is a method for detecting a cell proliferative disorder associated with DPC4. DPC4 is a marker which can be used diagnostically, prognostically and therapeutically over the course of disorders associated with DPC4.

Abstract: A method of performing immunoassay to detect the level of target proteins common to various malignancies including metallopanstimulin or metallopanstimulin-like materials as well as complement components, in a biologic sample is provided wherein the protein molecules in the patient sample compete with radiolabeled peptide for sites on the Anti-peptide-specific antibody. The amount of radioactivity measured is inversely proportional to the concentration of protein molecules present in the patient sample, which is determined from a standard curve. Another method includes determining the presence of a protein elevated in the serum of patients with neoplasms by the detection of the interference of binding or precipitation of a first antibody by a second antibody by the target protein.

Abstract: The invention is a method of identifying the presence of, and monitoring, a disease state in a mammal which is associated with degradation of connective tissue in the mammal. The method detects and determines whether diagnostically or prognostically significant levels of YKL-40 protein and/or YKL-40 peptide are present in a biological sample. The method can be used, for example, to identify the presence of inflammatory or degenerative joint disease or degeneration of connective tissue in organs. Serum YKL-40 levels as detected and quantified by the inventive method are also suggestive of the prognosis for the length of survival in breast cancer patients following recurrence and/or metastasis of their cancers. The figure shows the elution position of substantially pure serum YKL-40 on a gel filtration column.

Abstract: The invention refer to a method for diagnosing the presence of infection of papilloma virus (PV) and of papilloma virus (PV) carrying, especially cervix cancer and condyloma, by the detection of virus specific antigen-antibody complexes in immunossay.

Abstract: In vitro methods of determining whether or not an individual has metastasized colorectal cancer cells are disclosed. In vitro methods of determining whether or not tumor cells are colorectal in origin are disclosed. In vitro kits for practicing the methods of the invention and to reagents and compositions useful to practice the methods, for example as components in such in vitro kits of the invention are provided. Methods of and kits and compositions for analyzing tissue samples from the colon tissue to evaluate the extent of metastasis of colorectal tumor cells are disclosed.

Abstract: The present invention provides papillomavirus polypeptides and antibodies against said polypeptides. The peptides and antibodies of the present invention are particularly useful for in the prevention, diagnosis, and treatment of infections caused by distinct papillomaviruses. These papillomaviruses are linked to distinct infectious states. The polypeptides of the present invention are derived from L2 genes of different papillomaviruses (or from a portion of said genes). The present invention further provides kits containing one or more antibodies according to the present invention, and a method for the detection and identification of papillomaviruses in biological samples by immunological reaction with said antibodies. The diagnostic kits of the present invention are suitable for diagnosis of the specific infection affecting the donor subject of the biological sample, or infections to which the subject risks being exposed.

Abstract: A method for the early diagnosing of selected adenocarcinomas in a human comprising the steps of removing a bodily sample from the human, and assaying the bodily sample for elevated expression of a specific gene, the gene being assayed for in the bodily sample is the TGFB-4 gene (hereinafter referred to as the endometrial bleeding associated factor (ebaf) gene. The bodily sample can be tissue from a specific organ in the body, or a blood sample. Increased levels of ebaf in the sample relative to basal levels may be indicative of a mucinous adenocarcinoma of the colon or ovaries, or an adenocarcinoma of the testis.

Abstract: The present invention provides a recombinant toxin and monoclonal antibody which specifically binds to glial-derived or meningioma-derived tumor cells. Also provided are various methods of screening for malignant gliomas and meningiomas. Further provided are methods of treating malignant gliomas, including glioblastoma multiforme and astrocytomas.

Abstract: The present disclosure teaches that the proteins encoded by the BRCA1 and BRCA2 genes are found in the milk fat globule membranes from humans and cows. Therefore, BRCA1 and BRCA2 proteins can be isolated from milk produced by lactating animals. The level of expression of BRCA1 or BRCA2 can be determined by sampling the levels of BCRA1 or BRCA2 proteins found in the MFGM of lactating animals. The present invention also includes a method of determining the likelihood that a woman will develop breast cancer by measuring the amount of the BRCA1 or JBRCA2 expression during lactation. The detection of expression of BRCA1 or BRCA2 can be accomplished with an antibody raised specifically against BRCA1 or BRCA2 proteins, by isolating BCRA1 or BRCA2 from the milk fat globule membranes or by detecting activity of BRCA1 or BRCA2. The level of BRCA1 or BRCA2 is compared to a reference scale of propensity for breast cancer development correlated to normally active BRCA1 or BRCA2 levels.

Abstract: The invention involves the recognition of a previously identified protein, SCP-1, as a marker for cell transformation. Diagnostic and therapeutic uses of this protein and related molecules are taught. Also disclosed is a method for identifying substances which are immunoreactive and indicative of pathological conditions, using normal cells as source material.

Abstract: This invention relates to a method for the diagnosis of benign Barrett's Epithelium and Barrett's-derived adenocarcinoma. The method of diagnosis comprises contacting a monoclonal antibody which reacts with benign Barrett's Epithelium cells and Barrett's-derived adenocarcinoma cells, but does not react with normal esophageal epithelium cells, squamous carcinoma cells, cardia cells or gastric mucosa cells and detecting immunoreactivity. Immunoreactivity indicates a positive diagnosis Barrett's Epithelium or Barrett's-derived adenocarcinoma.

Abstract: This invention provides a method for detecting a rearrangement of a bcl-6 gene in B-cell lymphoma in a subject, comprising: (a) obtaining a DNA sample from the subject; (b) cleaving the DNA sample into fragments; (c) separating the DNA fragments by size fractionation; (d) hybridizing the DNA fragments with a nucleic acid molecule comprising at least 15 contiguous nucleotides which is complementary to a sequence of an isolated nucleic acid molecule having the nucleic acid sequence as set forth in SEQ ID NO:1 and specifically hybridizes with the nucleic acid sequence as set forth in SEQ ID NO:1 to detect the DNA fragment containing the bcl-6 nucleic acid sequence; and (e) comparing the detected DNA fragment from (d) with a DNA fragment from a known normal subject, the difference in size of the fragments indicating occurrence of a rearrangement of the bcl-6 gene in B-cell lymphoma in the subject.

Abstract: A method for determining whether a mammal should be medically investigated for a cancerous or pre-cancerous condition based upon the formic acid to nicotinic acid ratio in the blood of the mammal.

Abstract: During routine screening of a patient with a family history of colorectal cancer for truncating APC mutations, a novel missense mutation was identified. Upon further evaluation, it was found that 6% of Ashkenazi Jews carry this mutation, and that it was present in .sup..about. 20% of Ashkenazis with a family history of CRC. Probes, methods, and kits for identifying individuals affected with this missense mutation are provided.

Abstract: A screening test for identifying individuals having a predisposition to develop ovarian cancer. The test involves measuring the phenotypic expression of the CA125 antigen in overtly normal ovarian surface epithelium (OSE) cells propagated in vitro. The OSE cells are preferably passaged repeatedly prior to measuring for the expression of the CA125 antigen. The test is based on the finding that OSE cells obtained from individuals having a family history of ovarian and/or breast cancer retain sub-populations of CA125 expressing cells for longer time periods in vitro than OSE cells derived from individuals not having a such a family history. The test provides an alternative means of identifying and monitoring women at risk of developing ovarian cancer, including women with hereditary ovarian cancer syndromes and women likely to develop sporadic (non-familial) ovarian cancer.

Abstract: A sensitive method for measurement of telomeric DNA content in human tissue, based upon the ratio of telomeric to centromeric DNA present in the tissue.

Abstract: Methods are provided for determining in biological material the presence or amount human cyclin E polypeptide and/or cyclin E:cell division kinase complexes.

Abstract: A monoclonal antibody which specifically binds with an E2A/pbx1 fusion epitope.

Abstract: Nuclear matrix proteins (NMP) which are characterized by a defined expression in tissue are provided. These NMPs are useful markers in diagnosing and monitoring the stage of malignancy of a cell. Also provided are substantially purified polypeptides and nucleotide sequences encoding the NMPs of the invention.

Abstract: Cellular components are quantitated using stained cell samples, computerized image analysis, and cellular standards, where the computerized image analysis value can be translated into the amount of the component per cell. The methodology is demonstrated with breast cancer cells and quantitation of the HER-2/neu gene. The quantitation is shown to have prognostic capability as to the future course of the disease.

Abstract: The invention provides a method of diagnosing cancer by determining the expression level or gene amplification of p53 and dm2, whereby an elevated level of either p53 or dm2 or both p53 and dm2 indicates a cancer diagnosis. Furthermore, the invention provides a method of predicting the progress of cancer by determining the expression level or gene amplification of p53 and dm2, whereby an elevated level of either p53 or dm2 or both p53 and dm2 indicated a poor prognosis.

Abstract: The present invention provides a method of diagnosing APL in a subject which comprises detecting in a sample from the subject either nucleic acid encoding an abnormal RAR-.alpha. receptor or an expressed protein encoded thereby. The present invention also provides methods of identifying a subject with APL who will or will not respond to treatment with a retinoid, as well as a subjects with APL who do not express a detectable t(15;17) translocation but will or will not respond to treatment with a retinoid. In addition, the present invention provides methods for monitoring the activity of APL and the process of treatment of APL. The present invention provides methods of identifying a subject with a neoplastic condition other than APL who will or will not respond to treatment with a retinoid as well as methods for monitoring the level of disease activity and progress and adequacy of treatment of a neoplastic condition.

Abstract: A method of detecting malignant tumors and determining their mass includes withdrawing fresh blood and/or serum samples from the patient. The blood or serum sample is then stabilized. The tumor determination is obtained from a shift in the ratio of at least one of the IgG subclasses to the sum of the IgG subclasses, relative to the normal ratio in the samples.

Abstract: The invention provides methods and compositions for identifying colon cancers in an individual. In one embodiment of the invention, a colon adenocarcinoma-associated protein may be detected in a tissue or body fluid sample of an individual, to provide an indication of the presence of an adenocarcinoma of the colon in the individual. The target adenocarcinoma-associated protein, may be detected, e.g., by reacting the sample with a labeled binding moiety, such as a labeled antibody, capable of specifically binding the protein. In another embodiment, the protein may be detected by isolating one or more colon adenocarcinoma-associated proteins from the sample, separating the proteins by two dimensional gel electrophoresis, and comparing the gel electrophoresis pattern with a standard. The invention provides a wide range of assay methods and compositions which may be used for detecting colon tumors in an individual rapidly and reproducibly, optimally at early stages of the disease.

Abstract: The invention relates to an enzyme linked immunosorbent assay (ELISA) kit for the rapid determination of N-acetyltransferase (NAT2) phenotype which can be used on a routine basis in a clinical laboratory. The ELISA kit allows physicians to: a) individualize therapy of drugs such as amrinone, procainamide, amonafide, dapsone, isoniazid, trimethoprim-sulphamethoxazole (TMP-SMX) and b) to predict susceptibility to carcinogen induced diseases such as bladder and colon rectal cancers.

Abstract: Nuclear matrix proteins (NMP) which are characterized by a defined expression in tissue are provided. Also provided is an in vitro method for detecting prostate cancer in a sample employing a reagent that reacts with the NMP designated PC-1 (prostate cancer-1).

Abstract: Methods are disclosed for diagnosing diseases resulting from undesirable cell adhesion of IL-1 receptor positive cells to biological materials, particular to endothelial cells, or autoimmune related diseases, preferably graft versus host disease, or IL-1 dependent cancers.

Abstract: A glycoprotein antigen which is generally characteristic of human carcinomas, regardless of the tissue associated with the carcinoma--human carcinoma antigen (HCA)--and which is generally not present on normal human cells. Immunodeterminant-containing fragments of HCA substantially separated from elements of HCA's naturally occurring environment are also disclosed. HCA is generally characterized by: a) a molecular weight in excess of 750,000; b) carbohydrate moieties characteristic of mucin-type glycoproteins and comprising a relatively high proportion of sialic acid, galactose, and N-acetylgalactosamine residues (e.g., at least 50% of the carbohydrate residues are sialic acid, galactose, or N-acetylgalactosamine residues); c) an isoelectric point below pH 3.

Abstract: The invention is directed to a method for screening for possible prostate cancer presence. The method calls for assaying apolipoprotein D ("ApoD") levels in body fluids, such as serum. Assays for ApoD can be used prognostically, as well as diagnostically.

Abstract: Disclosed are novel polypeptides possessing part or all of the amino acid sequence or primary structural conformation and one or more of the biological properties of certain galactoside-binding-proteins with apparent molecular weights of 34,000 and 31,000. Genomic DNA, cDNA and manufactured DNA sequences coding for part or all of the sequences of amino acid residues of L-34-gal-lectin and L-31-gal-lectin are incorporated into vectors used to transform a host cell in culture. Also provided are antibodies against L-34-gal-lectin and L-31-gal-lectin and a method for inhibiting mammalian cell metastasis by treating mammalian cells in a living host with antibodies against L-34-gal-lectin or L-31-gal-lectin. A method of determining the metastatic potential of mammalian cells is also provided by which cells in vitro are contacted with antibodies against L-34-gal-lectin or L-31-gal-lectin which are labeled with a detectable probe.

Abstract: Non-invasive methods and kits are provided for obtaining biological samples of mammary fluid or mammary fluid components by administering oxytocin or an oxytocin analogue to a mammalian patient to stimulate expression of mammary fluid. The oxytocin is preferably administered intranasally and causes myoepithelial contraction of target alveolar-ductal tissues of the breast. During or after mammary fluid expression, a biological sample is collected in the form of whole mammary fluid, whole cells or cellular components, other selected liquid or solid fractions of the mammary fluid, purified or bulk proteins, glycoproteins, peptides, nucleotides or other desired constituents of mammary fluid. Methods and kits are also provided for determining the presence or amount of a breast disease marker in biological samples of mammary fluid or mammary fluid components.

Abstract: A method for the diagnosis of human malignancy is implemented in the following way: a blood smear from a patient finger is layered with a complexon solution and standard blood serum with a subsequent addition of a developer of Calcium-protein complexes, then after some time a comparison is made between the color and structure of the stain and a similarly obtained reference blood smear from a healthy individual and in case of differences a malignant tumor is diagnosed in the host. According to the invention various optimal ratios of reagents are offered enabling more reliable results.