Abstract: The invention relates to a novel epitope of 180,000 daltons for the NCAM antigen and a monoclonal antibody, SEN7, directed against this antigen, and their use in diagnosis and therapy of small-cell carcinoma of the lung. The antibody SEN7 reacts significantly more selectively than previously known antibodies with cells of small-cell carcinoma of the lung, and binds with high avidity. In particular, no reaction occurs with leucocytes or healthy kidney or lung epithelial cells. The novel antigen is dominantly expressed by cells of small-cell carcinoma of the lung with a high copy number.

Abstract: Disclosed are methods for the identification and characterization of tumor cell types present within malignant populations, and novel methods of cancer treatment. Tumor cells in cell cycle arrest have been identified, purified and characterized according to their size, altered morphology, surface phenotype and expression of oncogenes. Tumor cell cycle arrest can be induced in mice lacking an immune system solely upon administration of anti-idiotype antibodies. Methods of manipulating specific signals from the cell surface to alter the malignant phenotype of transformed cells are disclosed, as are methods for either eliminating or specifically maintaining tumor cells in cell cycle arrest.

Abstract: A process is disclosed which makes possible the isolation of the luminal endothelial cell membrane from associated tissue. It is particularly applicable to vasculature, but broadly is applicable to all tissue cavities which are accessible from adjacent perfusable lumens. The method involves the identification of characteristic molecules (primarily proteins and lipids) associated with the luminal surface of the any endothelial membrane in situ by utilizing a novel membrane-isolation scheme to separate the endothelium from associated tissue. The normal form of that tissue of interest and diseased and/or dysfunctional forms (such as tumors) can then be examined comparatively in order to identify proteins highly enriched and/or unique for normal and abnormal endothelia. This in turn permits the production of antibodies to the proteins of interest in order to develop probes specific for the abnormal tissue, such as vasculature of a tumor.

Abstract: This invention pertains to a method of assessing the ability of a compound to block or activate cell proliferation by assessing its effect on a cellular signal transduction pathway whose activation results in cell proliferation. In the present method, a cell-free system is used to assess the ability of a compound to block or activate a signal transduction pathway which is activated by binding of a growth factor to a cell surface receptor with intrinsic tyrosine kinase activity and whose activation results in proliferation of the cells to which growth factor has bound. Cellular signal transduction involves multiple pathways, each consisting of one or more steps emanating from a specific protein bound to a single receptor which is specific for that protein and located on the cell surface or within the cell.

Abstract: A process is provided for screening for a malignant tumor. The process comprises the steps of determining the amount of GlcNAc transferase V activity in a tumor sample by reacting the GlcNAc transferase V in a tumor sample with an acceptor substrate and a sugar nucleotide donor to produce a detectable change, and detecting the change. The acceptor substrate is an oligosaccharide, a glycopeptide or a glycoprotein having the structure GlcNAc .beta.1-2Man .alpha.1-6Man-R.sub.1. R.sub.1 is GlcNAc .beta.1-4GlcNAc with or without fucose or a synthetic linker. The sugar nucleotide donor is uridine diphospho-N-acetylglycosamine. The amount of GlcNAc transferase V activity in the sample is thereby determined. A determination of the malignancy of the tumor is made by comparing the amount of GlcNAc transferase V activity in the sample with an amount of GlcNAc transferase V associated with normal tissues or with known malignant tumors. A diagnostic kit for screening for a malignant tumor is provided.

Abstract: Disclosed is a method for the detection of gastric epithelial damage and a method which is performed by administering a disaccharide to a patient, assaying the patient's blood or urine for the presence of the disaccharide and correlating the determined disaccharide assay value to gastric epithelial damage.

Abstract: A method for automatic lineage assignment of acute leukemias. Eight four-parameter list mode data files are acquired with a flow cytometer in the following sequence: 1. unstained; 2. isotype controls; 3. CD10 FITC, CD19 PE; 4. CD20 FITC, CD5 PE; 5. CD3 FITC, CD22 PE; 6. CD7 FITC, CD33 PE; 7. HLADR FITC, CD13 PE and 8. CD34 FITC, CD38 PE. First, data files 3-8 are clustered employing an algorithm based on nearest neighbors. The clusters are then associated across the data files to form cell populations, using the assumption of light scatter invariance across tubes for each population. The mean positions of each cell population are compared to a decision tree which identifies normal cell populations. To identify leukemic cell populations, the algorithm eliminates normal cell populations from the data space and the remaining populations are classified as B-lineage ALL, T-lineage ALL, AML, AUL, B-CLL or unknown.

Abstract: This invention relates to a substantially purified p100 which is a human neu related protein having a molecular weight in the range from about 97,000 daltons to about 115,000 daltons which corresponds substantially to the extracellular domain of the human neu gene product, said protein being detectable in a biological fluid.In another embodiment this invention relates to assays for detecting this protein.Finally, this invention also concerns monoclonal antibodies which are capable of binding to p100.

Abstract: A new method of detecting cancer by determining the presence of autocrine motility factor (AMF) in the body fluid is described. The method utilizes induction of motility in suitable responder cells by a sample of the body fluid. If the responder cells demonstrate motility, cancer is indicated in the person from whom the body fluid was obtained.

Abstract: Methods for the detection, monitoring and treatment of malignancies are disclosed. Detection of the proliferation of T cells in response to in vitro exposure to a protein expression product of an activated oncogene or cancer-related gene associated with a malignancy, or detection of immunocomplexes formed between the protein expression product and antibodies in body fluid, allows the diagnosis of the presence of a malignancy. The present invention also discloses methods and compositions for treating a malignancy.

Abstract: This invention provides a specific immunocapture ELISA for the quantitation of cancer procoagulant antibody complex (CPAC) in biological samples. In particular, this invention provides methods and techniques for specifically selecting and quantitatively measuring CPAC from a sample material using anti-CP antibodies followed by labeled anti-immunoglobulin antibodies. The amount of captured CPAC is then determined by measuring the amount of label in the captured CPAC.

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 relates to the field of cancer immunoassay. Specifically, a new immunoassay method for prostate specific antigen (PSA) is presented. Also presented is a complex which resembles a complex of PSA and .alpha.-antichymotrypsin (ACT) that can be used as a calibrator or control in an immunoassay for PSA. Further presented is a method for fractionating polyclonal antibodies, to PSA, into those which bind epitopes that are masked by the binding of PSA to ACT and those which do not bind such epitopes.

Abstract: The invention is directed to A-lineage conotoxin peptides, which are conotoxin peptides that have strong homology in the signal sequence and the 3'-untranslated region of the genes coding for these peptides to the sequences in the .alpha.-conotoxin peptides. The A-lineage conotoxin peptides include the .alpha.-conotoxin peptides, the .alpha.-conotoxin-like peptides and the .kappa.-conotoxin peptides, described further below. The .alpha.-conotoxin-peptides generally share a "core" sequence motif. This core sequence is termed the .alpha.3/5 core and is represented as Cys-Cys-Xaa-Xaa-Xaa-Cys-Xaa-Xaa-Xaa-Xaa-Xaa-Cys (SEQ ID NO: 1). The .alpha.-conotoxin-like peptides generally share a core sequence termed the .alpha.4/7 core and is represented as Cys-Cys-Xaa-Xaa-Xaa-Xaa-Cys-Xaa-Xaa-Xaa-Xaa-Xaa-Xaa-Xaa-Cys (SEQ ID NO:2). The .kappa.-conotoxin peptides generally have a core sequence termed the .kappa.

Abstract: A method for aiding in the diagnosis of, and monitoring the progression of, breast cancer in a patient by measuring the amount of NCA 50/90 in a blood sample, e.g. serum sample, obtained from the patient. Measurement in a single sample of an amount of NCA 50/90 significantly higher than the mean amount of NCA 50/90 in the normal population is an indication of breast cancer in the patient. The progression of breast cancer can also be monitored by performing a series of specific immunoassays over time to determine changes in the level of NCA 50/90 in blood samples. Increases in blood NCA 50/90 levels over time are indicative of a deteriorating condition whereas decreasing levels of blood NCA 50/90 over time indicate an improving condition.

Abstract: Isolated complexes (which include basement membrane components), antibodies to such complexes or polypeptide constituents thereof, and methods for detecting such complexes or constituents are disclosed. Detection of such complexes in a biological sample by immunological and non-immunological methods allows the diagnosis of a variety of diseases, including cancers, collagen degenerative diseases, and hepatitis. Suitable biological samples include urine, cervical secretions, bronchial aspirates, sputum, saliva, feces, serum, synovial fluid, and cerebrospinal fluid.

Abstract: The invention concerns permanent cell lines of human promyelocyte cells characteristic of acute promyelocytic leukemias, these cells being cytogenetically characterized by a translocation t(15;17), capable of indefinite proliferation in a culture medium. It also concerns the use of these cell lines, particularly for screening molecules capable of inducing cell maturation.

Abstract: A method of monitoring markers of bone metabolism by continuously collecting a body fluid sample containing bone loss markers therein and analyzing the components of the body fluids for the markers of bone metabolism.

Abstract: The present invention provides methods for identifying molecular components (e.g. proteins and/or lipids) that are characteristic of vascular endothelia associated with a particular disease and are not also present in (i) normal (non-disease associated) vascular endothelia or (ii) non-disease associated vascular endothelia subjected to altered conditions that accompany the disease but are not unique to the disease.

Abstract: Methods for the diagnosis and prognosis of immunosuppressive conditions are disclosed, involving the detection of a particular isoform of ferritin, placental ferritin (PLF), in patient samples such as sera or on peripheral blood lymphocytes. PLF is elevated in immunosuppressed patients at early stages of disease; by contrast, adult insoferritins are elevated at late stages of immunodeficiency. Depending upon the nature of the disease associated with the immunodeficiency, the elevated levels of PLF detected at early stages may remain elevated or diminish as disease progresses. Examples are described in which elevated levels of PLF were detected at very early stages of of HIV-infection. The elevated levels diminished as disease progressed from ARC to AIDS. By contrast, adult isoforms of ferritin became elevated at late stages of disease.

Abstract: An alstonine composition is useful as a selective marker of tumor cells and/or of chromosomal aberrations, and for the detection thereof by measurement of fluorescence at about 375 nm. Thus, an alstonine preparation can be used as a diagnostic agent designed for selective detection of tumoral diseases, and in cytogenetics. The diagnostic agent has application in preoperative, peroperative and postoperative diagnoses.

Abstract: The invention provides a new method for screening for colorectal cancer by measurement of the level of lactoferrin or myeloperoxidase in feces. Particularly, a screening test method for colorectal cancer by measurement of the level of lactoferrin or myeloperoxidase in feces by immunoassay and by measurement of the level of whole-sized lactoferrin by immunoassay utilizing monoclonal antibody.

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: A method of detecting carcinoma, particularly breast carcinoma, in a test sample of tissue, comprising assessing the expression cyclin E, or the amplification of cyclin genes, particularly the cyclin E gene, is disclosed. Altered expression of cyclins, such as overproduction of cyclins, particularly cyclin E, or production of alternative cyclin E proteins, as well as deranged appearance of mitotic cyclins during the cell cycle, are indicative of the presence of carcinoma. Amplification of cyclin genes, particularly the cyclin E gene, is also indicative of the presence of carcinoma.

Abstract: Complexes (which include basement membrane components) and their polypeptide components are found to be related to the invasiveness of a bladder tumor. Detection of such complexes or constituents in a urine sample by immunological or non-immunological methods permits determining the invasiveness of a bladder tumor.

Abstract: The present invention is directed to the measurement of cell-associated interleukin-2 receptor .alpha. (IL-2R.alpha.) expression in solid non-lymphoid tumors, and the use of such measurement In prognosing the metastatic potential of the tumor, diagnosing the metastatic localization of non-lymphoid tumor, and aiding the monitoring of efficacy of anticancer therapy against metastatic cells of non-lymphoid tumor. The present invention also relates to the use of T-cell receptor (tumor specific TCR.beta. idiotype) in monitoring the efficacy of anticancer therapy against non-lymphoid tumors.

Abstract: There are provided a method and an apparatus for measuring an immunologically active material by physically or chemically immobilizing a material being immunologically active to a material to be measured of a specimen onto dehydrated solid fine particles, providing a desired dispersed body of said immunologically active material immobilized onto said solid fine particles in a dispersing medium, adding the specimen to said dispersed body while stirring to react the specimen with the immunologically active material, thereby causing a reaction mixture in an agglutinated state and optically measuring said agglutinated state of the reaction mixture to thereby quantitatively determine the content of the material to be measured with an improved accuracy.

Abstract: The present invention provides an isolated preparation of monoclonal or polyclonal antibodies which react specifically with human prostate-specific glandular kallikrein (hK2), but which do not cross-react with human prostate-specific antigen (PSA), as well as immunogenic hK2 antigens useful to provide such antibodies.

Abstract: The present invention relates to second generation monoclonal antibodies having binding specificity to a tumor associated glycoprotein having an approximate molecular weight of >10.sup.6 d ("TAG-72") and human carcinomas and methods for employing the same. Hybridomas producing such antibodies have been prepared.

Abstract: Isolated complexes (which include basement membrane components), antibodies to such complexes or polypeptide constituents thereof, and methods for detecting such complexes or constituents are disclosed. Detection of such complexes in a biological sample by immunological and non-immunological methods allows the diagnosis of a variety of diseases, including cancers, collagen degenerative diseases, and hepatitis. Suitable biological samples include urine, cervical secretions, bronchial aspirates, sputum, saliva, feces, serum, synovial fluid, and cerebrospinal fluid.

Abstract: A hybridoma capable of producing monoclonal antibody for recognizing hCG-.beta. core region and hCG-.beta. subunit, which is obtained by cell fusion of an antibody producing cell of a mammal immunized with hCG-.beta. subunit and a lymphoid cell line, and the monoclonal antibody are disclosed. The monoclonal antibody can be used in an immunochemical determination method useful for diagnosis of cancers.

Abstract: In a process for the purification of cytokeratin 20 (CK 20), a cytoskeletal fraction of cells containing CK 20 is produced, the proteins present therein are separated by gel electrophoresis or/and by chromatography and the CK 20 is isolated from the gel or the chromatographic fraction containing CK 20. In a process according to the present invention for the production of antibodies specific for CK 20, purified CK 20 is used for the immunization and then polyclonal or monoclonal antibodies are produced according to well-known methods. These antibodies are used for the immunologically identification of CK 20, or its .alpha.-helical central fragment obtained by proteolytic cleavage on tissue sections, in tissue homogenates and in body fluids.

Abstract: A biological sample such as feces, sputum, cervical tissue, pleural fluids, exudates, cytologic specimens, or the like, is tested for the presence or absence of: ova; parasites; microorganisms; inflammatory, neoplastic tissue cells; or other target materials which are indicative of infestation, disease or infection. The sample is mixed with a buffer fluid and placed in a transparent tube which contains a volume-constricting cylindrical insert for gravimetric separation of components of the sample. The mixture is centrifuged, and the annular space between the insert and tube bore is examined under magnification for the presence of the target materials.

Abstract: Monoclonal antibodies are provided which bind to an antigen associated with prostate cells, including prostate cancers. The monoclonal antibodies and recombinant forms thereof are used individually or conjugated radioisotopes to target the compounds to cancerous prostate cells, and thus are useful in a variety of diagnostic procedures.

Abstract: A method for detecting the presence of cancer employs monoclonal antibody OXA or OXB, antibodies which bind to the antigen bound by monoclonal antibody OXA or OXB, or fragments of the foregoing which bind to the antigen bound by monoclonal antibody OXA or OXB. The method comprises contacting a sample of a biological fluid from a subject with the antibody under conditions permitting the antibody to form a reaction product, and then detecting the presence or absence of the reaction product. The method is particularly useful for monitoring the progression of treatment in a patient previously diagnosed as having ovarian or colon cancer. The method is also useful for detecting and monitoring endometrial cancer, and for detecting colon cancer.

Abstract: A handling and processing apparatus for preparing Oxygen-15 labeled water (H.sub.2 [.sup.15 O]) in injectable form for use in Positron Emission Tomography from preferably H.sub.2 [.sup.15 O] produced by irradiating a flowing gas target of nitrogen and hydrogen. The apparatus includes a collector for receiving and directing a gas containing H.sub.2 [.sup.15 O] gas and impurities, mainly ammonia (NH.sub.3) gas into sterile water to trap the H.sub.2 [.sup.15 O] and form ammonium (NH.sub.4.sup.+) in the sterile water. A device for displacing the sterile water containing H.sub.2 [.sup.15 O] and NH.sub.4.sup.+ through a cation resin removes NH.sub.4.sup.+ from the sterile water. A device for combining the sterile water containing H.sub.2 [.sup.15 O] with a saline solution produces an injectable solution. Preferably, the apparatus includes a device for delivering the solution to a syringe for injection into a patient. Also, disclosed is a method for preparing H.sub.2 [.sup.

Abstract: Cellular DNA repair enzyme activity has been found to be an indicator of susceptibility or predisposition of an individual to DNA associated diseases. The activity of the enzyme adenosine diphosphate ribosyl transferase (ADPRT) has been found to be a good indicator as to the susceptibility of an individual to DNA associated diseases, such as cancer.

Abstract: The invention concerns a process for the quantitative determination of prostate specific antigen in a patient sample, with a predetermined weight or volume, through analysis. A patient sample undergoes a freeze concentration, is analyzed by standard quantitative analysis methods such as immunoassay techniques, and then the substance content is calculated back to the original sample volume or weight.

Abstract: The invention provides a method of treating cancer in a mammal comprising administering to the mammal an effective amount of modified C-reactive protein ("mCRP"). The invention also provides a method of treating cancer in a mammal comprising administering to the mammal mCRP in combination with another agent such as a chemotherapeutic compound, immunoadjuvant, or cytokine. The mCRP may be administered to the mammal in a pharmaceutically-acceptable carrier or in liposomes. The invention further provides a method of identifying cancer cells in a mammal using mCRP as an imaging agent.

Abstract: A test kit and method for the amplification and detection of specific antigen cells using a probe. The method includes reacting the probe-specific cells with enzyme-conjugated molecules to form separate molecules. The specific antigen cells are mixed with a selected antibiotic which antibiotic is adversely affected by the enzyme in the reporter molecules and incubating the mixture to promote a bacterial chain reaction forming satellite colonies of bacteria microcolonies about the specific cells which amplifies the cells. The method then includes detecting the amplified probe-specific cells by observing the satellite colonies.

Abstract: A purified proteinaceous substance bindable with p185, the translation product of the neu oncogene is disclosed. The purified proteinaceous substance may be characterized in that it increases the activity of the tyrosine kinase contained in the neu oncogene product but does not increase the activity of tyrosine kinase of epidermal growth factor receptor; induces p185 dimerization and internalization; affects the growth of cells which express p185 in a dose dependent manner; is heat stable from about 56.degree. C. to about 100.degree. C.; is degradable by protease; and has a molecular weight of from about 7,000 to about 14,000 daltons in its smallest active form as determined by gel filtration and ultrafiltration membrane analysis. Methods of detecting p185 on the surfaces of tumor cells are also disclosed.

Abstract: The amount of lipid bound sialic acid in a blood plasma or serum sample may be determined by an improved method, which may be automated, involving the following steps to be performed simultaneously on the sample and a standard consisting of commercially available n-acetyl nueraminic acid (NANA); diluting with a buffer; mixing the diluted sample; adding a mixture of a chlorinated lower aklyl hydrocarbon and a lower alkyl alcohol; treating by mixing and centrifuging to yield a substantially clear upper phase; treating the upper phase with a color development reagent; mixing; boiling the admixture; cooling the admixture; and determining the amount of lipid bound sialic acid present in the sample by comparing the optical density of the sample to the optical density of the NANA.

Abstract: A method is described for identifying and localizing tumors in a patient. The method comprises assaying extracellular fluids, isolated from a patient, for the presence of elevated levels of ring shaped particles (RSP). The assay employs binding labeled RSP specific binding agent to the RSP.

Abstract: The present invention relates to a novel monoclonal antibody reactive with human colorectal mucin antigen. More particularly, the antibody of the invention is a murine monoclonal antibody, CT43, reactive with a novel antigenic determinant on much antigen highly correlated with human colorectal cancer. The antigenic determinant found by the CT43 has been characterized as neuraminidase and proteinase K resistant, periodate sensitive and unreactive with the glycoconjugates of Table 2. Methods are provided for the detection and quantitation of the CT43 antigenic determinant and its correlation with colorectal cancer. CT43, and CT66 specific for the sialylated Lewis a and Lewis a antigen have been deposited with the American Type Culture Collection, as accession numbers ATCC HB 10217 and ATCC HB 10218, deposited Sep. 6, 1989.

Abstract: This study describes method for extraction and quantification of calprotectin (L1 protein) in feces by enzyme immunoassay. This protein is a prominent antimicrobial component of neutrophils, monocytes, macrophages and squamous epithelia. Calprotectin was stable in feces during storage for seven days at room temperature. Fecal calprotectin quantitated in a five gram sample taken from a 24 hours feces collection gave a reliable estimate of calprotectin found in the pooled collection. The assay had a within assay precision (=CV) of 1,9% and a between assay precision of 14,8%. The following mean fecal calprotectin levels were found: Healthy subjects (n=33) 3095 .mu.g/l, hospital controls (n=40): 14697 .mu.g/l, patients with inflammatory bowel disease (Crohn's disease and ulcerative colitis), (n=28) 40850 .mu.g/l. The differences between the means are highly significant.

Abstract: The invention relates to a method of predicting disease-free survival in cancer patients by relating the number and amount of stress response proteins in cancer tissue to the probability of tumor recurrence. Particular heat shock/stress response proteins useful in the determination of tumor recurrence are the stress response proteins, hsp70, hsp90, hsp27, and glucose regulated protein grp94. Specific levels of the stress response proteins relative to an internal standard are identified, above which the probability of tumor recurrence is highly significant. Kit methods are disclosed which could enable determination of the stress proteins by an antibody assay.

Abstract: This invention relates to monoclonal antibodies capable of specifically reacting with a peptide encoded by tumor suppressor gene DCC gene and to hybridomas capable of producing such monoclonal antibodies. In particular, the invention relates to mouse monoclonal antibody KM890 belonging to the IgG3 subclass, which is specifically reactive with a DCC gene DCC-2, and to a hybridoma KM890 capable of producing the monoclonal antibody KM890.The monoclonal antibodies of this invention which are specifically reactive with DCC gene products can be used in immunohistochemical staining, quantitative determination of DCC gene products and the like, as well as in cancer diagnosis.

Abstract: The present invention relates to the purification of the human chorionic gonadotropin .beta.-core molecule which can then be used as the antigen in the preparation of antibodies to the .beta.-core molecule. The combination of the purified .beta.-core molecule and the antibodies can be used in an immunoassay kit to measure .beta.-core molecules in the presence of structurally similar molecules, i.e., hCG, LH, hCG.beta.-subunit and LH.beta.-subunit. Measurement of the .beta.-core molecule is particularly useful in testing for pregnancy and many malignancies.

Abstract: Detection, quantitation and classification of ras p21 proteins in body fluids, tissues, or cells is described. Specifically, this disclosure concerns detecting and quantitating normal and mutated ras p21s from normal subjects, subjects suspected of having preneoplastic disease or subjects known or suspected of having neoplastic (cancer) disease. This invention also concerns the detection and quantitation of the ras p21 proteins into the three families of ras proteins designated Ha, Ki and N in body fluids and tissues.

Abstract: A new NM23 gene and its relationship with metastatic potential of tumor cells is described.