Abstract: A method and a test kit for rapidly determining the presence of functional cellular steroid receptors by assaying a tissue sample for nuclear steroid or antisteroid binding is disclosed which comprises treating the tissue with collagenase, incubating the isolated cells with a labelled steroid or a labelled antisteroid capable of complexing said receptors and measuring the bound nuclear radioactivity and the DNA of the isolated cellular nuclei.

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: Immortalized human epithelial cell sublines are provided. The novel cell lines do not undergo terminal differentiation and senescence upon exposure to high calcium concentrations. The novel cells exhibit positive reactivity with milk-fat globule membrane antigen and cytokeratin anti-serum. The cells are non-tumorigenic in athymic mice, and exhibit both three-dimensional growth in collagen and dome formation in confluent cultures. The cell sublines demonstrate growth control by hormones and growth factors. The novel cell sublines are useful in evaluating the capacity of preselected agents to bring about a change in epithelial cell growth and in the production of proteins.

Abstract: Methods and compositions are provided for detecting antigens having a specific epitope associated with squamous lung carcinoma. The antigen may be found at lesion sites or in the blood as indicative of the squamous lung carcinoma.Specific antibodies may be used for the detection of the antigen and in therapy.The mouse hybridoma 43-9F producing IgM monoclonal antibody 43-9F and SLC cell RH-SLC-L11 were deposited at The PHLS Centre for Applied Microbiology and Research, Porton Down, Salisbury, U.K. on Jan. 31, 1985 and given Accession Nos. 85013101 and 85061403, respectively.

Abstract: The sequence of the protein coding regions of the bcl-2 gene are provided as well as bacterial clones which produce the proteins. Assays are provided for detecting a class of B-cell neoplasms associated with a chromosome translocation between chromosomes 14 and 18. This translocation is involved in the majority of cases of human follicular lymphomas. One assay employs an antibody which is immunoreactive with a human protein which is over-expressed due to the chromosome translocation. Another assay involves measurement of the amount of mRNA which hybridizes to the gene proximal to the translocation break-point.

Abstract: Disclosed are immunological methods and materials for detection of antigens associated with breast or prostate cancer disease states. Presently preferred antibody preparations (e.g., PR92 monoclonal antibodies produced by hybridoma cell line ATCC HB 9390) are employed in immunoassays performed on patient body fluids and for purification of tumor-associated antigen compositions.

Abstract: The invention relates to an immunometric assay for a multivalent antigen in a sample which comprises forming a complex of the antigen together with multiple immobilized monoclonal antibodies against different epitopes of the antigen and with a detectably labeled soluble monoclonal antibody which is identical to one of the multiple immobilized antibodies. The labeled antibody associated with the complex is separated from the remaining soluble antibody and the detectably labeled antibody associated with the complex or unassociated with the complex is detected. Any one of the multiple immobilized monoclonal antibodies shows, by itself, substantially less binding towards the antigen in the immunometric assay, when used with itself or another monocolonal antibody in soluble labeled form, than when used with the multiple immobilized antibodies in combination.

Abstract: An image analysis system is used for the quantitation of nuclear proteins in cell populations. Particularly, the hormonal receptor content of fine needle aspirates of human breast carcinomas are evaluated. Estrogen or progesterone receptors are amplified and visualized in the specimen by a staining technique of the immunoperoxidase type. Monoclonal antibodies specific against the receptor are attached to the receptor sites and are then amplified by a bridging antibody which attaches to the monoclonal antibody and a peroxidase-antiperoxidase complex. A chromagen, diaminobenzidine is combined with the complex and treated with hydrogen peroxide to react with the peroxidase forming an insoluble brown precipitate which marks the receptor sites for optical identification. The specimen is then counterstained with another chromagen, methyl green which is specific to the nucleus of each cell.

Abstract: The present invention is directed to the measurement of soluble T cell growth factor receptors, soluble T cell differentiation antigens, or related soluble molecules or fragments thereof, and the use of such measurements in the diagnosis and therapy of diseases and disorders. The measurement of such molecules can be valuable in monitoring the effect of a therapeutic treatment on a subject, detecting and/or staging a disease in a subject, and in differential diagnosis of a physiological condition in a subject. These measurements can also aid in predicting therapeutic outcome and in evaluating and monitoring the immune status of patients.In specific embodiments, measurements of serum or plasma interleukin-2 receptor levels can be made, to detect or stage leukemia or lymphoma. In other embodiments, IL2R levels, or CD8 levels, can be used to differentially diagnose renal allograft rejection, as distinguished from Cyclosporin A nephrotoxicity.

Abstract: A tissue analysis device includes first and second plates which are rigid and radiographically transparent, at least one of the plates defining a plurality of pinholes arranged in an evenly spaced pattern to form a rectangular grid, with at least one of the plates including coordinate markings which can be seen both optically and radiographically to create a rectangular coordinate system for defining each section of the grid.

Abstract: A method for separating male and female determining spermatozoa includes the initial step of exposing freshly ejaculated spermatozoa in a substantially protein free diluent to an excess concentration of a monoclonal antibody directed against H-Y antigen that binds substantially exclusively with male determining spermatozoa. The method continues with the suspending of the exposed spermatozoa together with a conjugate of (1) an immunoglobulin G antibody that binds substantially exclusively to the monoclonal antibody and (2) an immunoabsorbant substrate in a substantially protein free diluent. This forms a conjugate/spermatozoa preparation. The method concludes with the recovering of the separated male and female determining spermatozoa.

Abstract: A unique, quick, inexpensive and highly accurate assay for detecting the presence of tumor promoters based on a measurable set of changes in amphibian oocytes in the presence of a tumor promoter. A secondary assay based on the protein released by the oocytes is employed to confirm the initial assay and quantify the potency of the tumor promoter present.

Abstract: A method is disclosed for the analysis of gene expression in human biopsy that is useful in the diagnosis and prognosis of disease and evaluation of risk for disease. The method comprises the steps of compiling data regarding the level of expression of certain individual cloned gene sequences from patients having defined pathological conditions and from normal patients and thereafter identifying sequences that characterize the pathological condition.The data regarding the expression of the individual cloned genes are stored in a defined pattern or array. Replicas of this array are hybridized to radioactive probes made using the RNA isolated from biopsy tissue. The extent of hybridization of the probe to each of the cloned sequences is proportional to the level of expression of the cloned sequence in the tissue from which the probe was made. This may be done by exposing the hybridized clones to x-ray film and scanning the x-ray films to quantify the cloned sequences.

Abstract: A substantially pure antigen found on normal and benign breast epithelial cell membranes and in breast cancer cells, fused cell hybrids which produce antibodies specific for such antigen, the monoclonal antibodies produced by such fused cell hybrids, a method for detecting the presence of breast cancer in a patient which is based on measuring the concentrations of one or more determinants of such antigen in a patient sample, and a method for either identifying those breast cancer patients whose tumors would respond to estrogen manipulation or determining prognosis based on the degree of differentiation, which method is based on measuring the concentration of an estrogen-modulated determinant of such antigen.

Abstract: This invention relates to DNA having at least 60% homology relative to .gamma.-RNA or a portion thereof and the capacity of selective hybridization with .delta.-RNA. Such DNA, if provided with a detectable label, such as .sup.32 P can be used as a diagnostic agent to diagnose .delta. infection.

Abstract: A protein antigen related to the dihydro-pyridine-sensitive calcium channel is expressed at high levels by small cell carcinoma of the lung and neuroblastomas. The antigen serves as a marker which can be exploited for diagnosis and therapy of these tumors. Methods of diagnosis and therapy of small cell carcinoma of the lung and neuroblastomas employing monoclonal antibodies which are specific for the dihydropyridine-sensitive calcium channel are also described.

Abstract: Pancreatic disease can be diagnosed by assaying a patient's body fluid, e.g. serum or urine, for the activation peptides of pancreatic zymogens specifically cleaved by proteolysis during activation, (PAP) e.g. peptides including the sequence D.sub.4 K having the lysine as the carboxy terminus. When PAP is assayed for, the test provides a means for distinguishing necrotising acute pancreatitis from oedematous acute pancreatitis, provides for diagnosis of chronic pancreatitis in exacerbation, and permits monitoring of the severity progress of the disease. Also described are antibodies having specificity for the pancreatic activation peptides, as well as such peptides and antibodies which are labelled with revealing agents and/or immobilized on solid supports, and their use in diagnostic test kits.

Abstract: A process for detecting cancer in a human patient is provided wherein a blood serum is recovered from the patient and is reacted with a monoclonal antibody comprising anti-haptoglobin variant under conditions to effect an immunoreaction when an immunosuppressive factor having a molecular weight of about 50K Daltons is present in the serum. The presence of immunosuppressive factor at concentration levels substantially exceeding normal concentration levels indicates the existence of immunoincompetence due to widely spread cancer. The effectiveness of cancer therapy is monitored by monitoring the change in levels of the immunosuppressive haptoglobin variant factor in the serum from the patient being treated.

Abstract: A method for detecting and localizing single base substitutions in RNA or DNA that involves RNAase A cleavage of single base mismatches in RNA:RNA or RNA:DNA heteroduplexes. A RNA probe complementary to wild type DNA is annealed to the test DNA containing a single base substitution. Many of the possible single base mismatches can be cleaved by RNAase A. The location of the single base substitution can be determined by analyzing the sizes of the RNA cleavage products.

Abstract: A procedure for the immunoassay of a proteolytic procoagulant enzyme in biological samples is described. The presence of the enzyme is indicative of malignant disease, and the immunoassay is used as a diagnostic test for cancer.

Abstract: An immunochemical assay to determine the presence or concentration of antigen or antibodies in a fluid, comprising: (a) forming a ternary complex of a first labelled antibody or antigen, a second labelled antibody or antigen, and the antigen or antibody to be determined; and (b) detecting a signal produced in the presence of at least one substrate, by an interaction between said first label and said second label, enhanced by their proximity to each other bound to the antigenic substance.

Abstract: This invention relates in general to a phosphoprotein product of the retinoblastoma susceptibility gene. In particular, this invention relates to a phosphoprotein ppRB.sup.110 primarily located in the cell nucleus which has a DNA binding activity. The invention also relates to the amino acid sequence of the phosphoprotein and to the specific purified anti-retinoblastoma phosphoprotein antibody. The invention further relates to a method of diagnosing retinoblastoma and other retinoblastoma gene involved cancers, treating such kind of cancers and regulating the oncogenicity of other genes.

Abstract: A kit for compounding radiolabeled monoclonal antibodies or antibody fragments for in vivo cancer diagnosis and therapy, which provides reagents for: (1) the selection of monoclonal antibodies or antibody fragments which are specific to a tumor specimen; (2) compounding the selected antibodies with a radionuclide material; and (3) quality control testing of the resulting compound. In the method of the invention, multiple aliquots of tumor biopsy material are fixed onto separate test areas of an apparatus which permits reaction with a panel of various monoclonal antibodies or antibody fragments known to react with tumor associated antigens. If one or more of the antibodies or antibody fragments bind to the tumor specimen, the reagents and antibodies or antibody fragments contained in the kit are combined with an appropriate, commercially available radionuclide.

Abstract: A substantially purified carbohydrate is provided which is isolated from chronic myelogenous leukemia cells. The carbohydrate is immunogenic and can be utilized to raise both polyclonal and monoclonal antibodies.

Abstract: Fragments of a biopsy sample on the order of about 50 to 5000 cells are preferred for establishing viable tumor cell cultures for purposes such as establishing cell lines, chemotherapeutic assays and the like. Such fragments retain the three-dimensional cellular structure or organization of the original tumor and, therefore, can be cultured more readily. To obtain such fragments suitable for culturing, the biopsy sample can be enzymatically digested in a proteolytic or nucleolytic enzyme, such as collagenase, or by mechanical dissociation, or both where necessary. The fragments can then be suspended in an aqueous medium so that non-aggregated cells (e.g., red blood cells, lymphocytes, macrophages) and cellular debris will form a supernatant while the remaining fragments containing aggregated tumor cells are deposited in a sediment layer.

Abstract: A method and kit are described for detecting the presence of cancers and pre-neoplastic cells that produce an oncofetal phosphoprotein having a molecular weight of approximately 60,000 and having the capacity to increase the release of ribonucleic acid from cell nuclei. The method involves detecting the presence of auto-antibodies to this oncofetal phosphoprotein in a subject suspected of suffering from a cancer or pre-neoplastic cells which produce this cancer marker protein. The kit includes purified oncofetal phosphoprotein.

Abstract: A process for determining genetic susceptibility to cancer is disclosed in which the frequency of chromatid breaks and gaps is calculated in metaphase skin fibroblasts or stimulated peripheral blood lymphocytes after x-irradiation or fluorescent light exposure. Susceptibility to cancer is found when the frequency of breaks and gaps in the cell sample is two to three-fold higher than that occurring in comparable cells from control individuals. Various factors have been found which influence the accuracy of the test results. These factors include pH, temperature, cell density, culture medium or serum, microbial contamination and visible light exposure (effective wavelength 500 nm). Additionally, because of experimental variability, known normal controls are suggested for use in each test group.

Abstract: Neoplastic and other diseases can be diagnosed by assaying a human test sample e.g. body fluid, tissue or cultured tumor explant cells, for structurally altered or abnormally expressed growth factor receptors or for the RNA transcripts of genes which encode them. For example, the assay can be for truncated EGF receptor having at least a portion of its mature amino terminus deleted. Antibodies, capable of binding a predetermined amino acid sequence within the EGF receptor, are also useful in diagnosis and therapy as are conjugates of an immunogenic polymer bound to a polypeptide fragment of EGF receptor. DNA and RNA encoding EGF receptor or fragments thereof are also described.

Abstract: Human cancer is diagnosed/monitored by measuring the levels of N-[9-(.beta.-D-ribofuranosyl)purin-6-ylcarbamoyl]-L-threonine (t.sup.6 A), in a physiological fluid specimen of a subject by a quantitative immunoassay that employs a monoclonal anti-t.sup.6 A antibody and comparing that level to the level of t.sup.6 A that occurs in corresponding physiological fluid of normal subjects to determine whether the former is substantially elevated over the latter or by comparing that level to the level of t.sup.6 A present in specimens taken from the subject at different times.

Abstract: A method is provided for the detection of a disease associated with the metabolic abnormality of L-fucose in a subject. The concentration of free L-fucose in a specimen from the subject is determined and the determined concentration is compared with a normal concentration of free L-fucose.

Abstract: Monoclonal antibodies specific for the 8R,6R- and 8S,6S-stereoisomers of 3-(2-deoxy-.beta.-D-erythropentofuransyl)-5,6,7,8-tetrahydro-8-hydroxy-6-m ethylpyrimido[1,2-a]purine-10(3H)one were produced. These cyclic 1,N.sup.2 -propanodeoxyguanosines are formed in DNA exposed to crotonaldehyde in vitro. Three of the four antibodies were most specific for one stereoisomer while the fourth was most specific for the other stereoisomer. Fifty % inhibition of binding in an enzyme-linked immunoabsorbent assay could be achieved with 0.2 picomol of either stereoisomer. A high-pressure liquid chromatography-enzyme-linked immunoabsorbent assay using two of these antibodies and capable of detecting 0.5 .mu.mol of 1,N.sup.2 -propanodeoxyguanosine per mol of deoxyguanosine was developed. The method was validated by comparison to results obtained with fluorescence assay.

Abstract: A new marker for colorectal carcinoma has been discovered which is a glycoprotein having a molecular weight of approximately 160,000 daltons. Assay methods which can identify this marker are useful indetecting, diagnosing, and monitoring colorectal carcinoma, and in particular, carcinoma of the undifferentiated variety which heretofor were not readily detectible. For example, an assay which utilizes an antibody reacting to this glycoprotein marker is useful in a screening method for the detection and monitoring of colorectal carcinoma cells. Such an antibody can be included as part of a kit for screening a patient for colorectal carcinoma.

Abstract: The present invention relates to a 40 kilodalton subunit of serous cystadinocarcinoma ovarian tumor associated antigen CA125, useful in the diagnosis and monitoring of ovarian cancer. It also relates to an immunoassay method for detection of the antigen in serum for diagnosis and monitoring purposes.

Abstract: A specific high molecular weight antigen (gp650) is detected in the sera of cancer patients with gastrointestinal cancer, cancer of the liver, breast cancer, cancer of the lung, cancer of the tongue, fallopian cancer, lymphoma and multiple myeloma. A monoclonal antibody specific for the 650 kD high molecular weight glycoprotein antigen has been harvested from mouse ascites and culture supernatants and used for the detection of antigen in cancer patient sera. Disclosed are (1) the method for preparing the antigen, (2) the properties of the antigen, (3) the method for preparation of the monoclonal antibody, (4) the characteristics and specificity of the monoclonal antibody and (5) a diagnostic kit based upon the specific monoclonal antibody.

Abstract: Disclosed is a glycoprotein, carcinoma orosomucoid-related antigen, (CORA), which has a binding affinity for carcinoembryonic antigen (CEA). This glycoprotein is a marker for carcinoma, and can be characteried by having a molecular weight of about 46,000-50,000 daltons, an isoelectric point of about 3.0-3.5, a carbohydrate content of about 25-35% by weight, reactivity with antisera raised thereto, and substantially no reactivity with antisera raised to nonspecific cross-reacting antigen (NCA) or to CEA. Also disclosed are a hybridoma which produces a monoclonal antibody to CORA, the monoclonal antibody to CORA, and a device, kit, and method for detecting and monitoring carcinoma.

Abstract: A method for distinguishing between carcinomatous and/or precarcinomatous colo-rectal disease and histologically similar conditions due to diseases that are not carcinomatous or precarcinomatous comprising contacting colo-rectal tissue with an antibody that binds to blood group substance H and determining the presence of carcinomatous or precarcinomatous disease upon a finding of bound antibody, or the absence of such disease upon the finding of no bound antibody.

Abstract: There is disclosed a measurement reagent for a human Cu.Zn-superoxide dismutase (SOD) which comprises an anti-human Cu.Zn-SOD monoclonal antibody labelled with an enzyme, a method for measuring a human Cu.Zn-SOD which comprises measuring the human Cu.Zn-SOD with the measurement reagent for the human Cu.Zn-SOD, and an anti-human Cu.Zn-SOD monoclonal antibody by the enzyme-linked immunosorbent assay according to the sandwich method, a diagnostic test drug for a human cancer of the stomach which comprises the measurement reagent and a method for diagnosing and testing a human cancer of the stomach which comprises measuring the human Cu.Zn-superoxide dismutase with the measurement reagent, and an anti-human Cu.Zn-superoxide dismutase monoclonal antibody by the enzyme-linked immunosorbent assay according to the sandwich method.

Abstract: Tumor nucleoli were treated with polyclonal antisera to normal human tissue nucleoli to block determinants common to tumor and normal tissue nucleoli. Immunization of mice with these immune-complexes resulted in the development of a monoclonal antibody (FB2) to a novel nucleolar proliferation associated antigen which has a molecular weiThe present invention was made with partial support from Federal funding grants. Subject to these grants, the Government may exercise certain rights in the invention.

Abstract: Antibody defining structure present in fibronectins from tumors and fetal tissues but absent in fibronectins from normal adult tissues and plasma; useful for diagnosing and treating human cancers.

Abstract: A very rapid, sensitive method if provided for determination of the potential mutagenicity and/or carcinogenicity of certain petroleum oils by nitration of the oil and comparison of the light absorbance of its nitrated material with that obtained from one or more oils of known mutagenicity and/or carcinogenicity.

Abstract: This invention relates to the use of a specific carcinoma associated antigen/hapten of carbohydrate nature, fucosylsialosylgangliotetraose-IV.sup.2 -Fuc.alpha.-II.sup.3 NeuAc.alpha.-GgOse.sub.4 (Lipid Document, 1977) and defined derivatives, as well as to the use of antibodies against this antigen or its derivatives for body treatment procedures related to human cancer (exemplified by small cell carcinomas of the lung).

Abstract: This invention provides a reagent capable of binding to T cells and having specificity for a unique sequence within the variable region of the .beta. chain of the T cell receptor, the presence of increased number of T cells carrying the unique sequence relative to the number of T cells carrying the sequence present in a normal subject being associated with a specific disease. Specific diseases such as human cancers, e.g. lymphomas; autoimmune diseases, e.g. rheumatoid arthritis; Alzheimer's disease; infectious diseases, e.g. those caused by bacteria, yeast or parasite; or allergies, may be diagnosed as follows. A suitable sample containing T cells is obtained from a subject. The sample is contacted under appropriate conditions with such a reagent. If the subject's cells contain the unique sequence, a detectable complex is formed between the reagent and T cells which contain the sequence.

Abstract: The present invention is concerned with novel monoclonal antibodies specific for an antigenic site on a protein characteristic of a human basal cell and a malignant squamous cell. The antibodies do not bind to mesenchymal cells such as fibroblasts and endothelial cells. The protein on the cell surface which binds to one of the antibodies has a molecular weight of about 120,000 as determined by one dimensional gel electrophoresis. The antibodies find use in diagnostic methods such as the detection of malignant cells, e.g., the detection of residual tumor cells in skin subjected to microscopically-controlled surgery.

Abstract: There are provided monoclonal antibodies which react with human oncofetal ferritin and which do not react with human spleen ferritin or with liver ferritin; there are also provided monoclonal antibodies which react both with human placenta oncofetal ferritin and with human adult spleen ferritin. There is provided a process for producing clones producing such antibodies and such clones, and an assay for the detection of human breast cancer based on the determination of oncofetal ferritin, which assay is based on such monoclonal antibodies.

Abstract: An antigen for the detection of Compylobacter pylori infections and an assay for the serological detection of Campylobacter pylori. The antigen includes high molecular weight cell-associated proteins purified from Campylobacter pylori. The antigen can be used in a variety of assays including radioimmunoassay, ELISA, latex agglutination, complement fixation, and indirect hemagglutination. Furthermore, the antigens can be combined with a solid support in kit form.

Abstract: The present invention is concerned with two novel monoclonal antibodies which define carbohydrate antigens associated with human non-small cell lung carcinomas ("NSCLC") and certain other human carcinomas. The antibodies bind to normal human cells to a much lesser degree than to tumor cells. The antibodies find use in diagnostic methods such as the detection of malignant cells associated with NSCLC and in therapeutic methods. The invention also comprises a method for determining the presence of a malignant condition in the lung of a subject. The method involves examining tissue from the subject for the presence of antigens which are Le.sup.x or Le.sup.y antigen or which have the characteristics of Le.sup.y and Le.sup.x.

Abstract: A process for producing monoclonal antibodies specific to carcinoembryonic antigen (CEA), comprising immunizing a mammal with a first CEA to produce cells capable of producing antibodies, collecting the cells from the mammal, fusing the collected cells with the cells of a line of myeloma of another mammal, selecting the thus-obtained hybridoma cells on the basis of their capacity to produce antibodies reactive with said first CEA, subjecting the thus-selected hybridoma cells to cloning, selecting the thus-obtained monoclones on the basis of the reactivities of monoclonal antibodies produced by them with at least one antigen selected from CEAs other than said first CEA and CEA-related antigens of normal adult human origin, culturing the thus-obtained monoclones and recovering the desired monoclonal antibodies from the spent culture. The selection may preferably be effected by radioimmunoassay using a marker antigen labelled with a radioactive substance.

Abstract: Molecules complementary to nucleotide sequences encoding mutant ras protiens which contain a single-base mutation in the codon encoding amino acids at position 13, 12 or 61 have been produced. These molecules are useful in methods of detecting specific single-base mutations in altered ras genes and the specific cancers associated with such mutations.

Abstract: Provided are hybridomas for producing monoclonal antibodies against human prostate secretory protein (PSP15), anti-PSP15 monoclonal antibodies, fragments and derivatives thereof, and methods for their use. The antibodies are monospecific, bind to protein A and are of the IgM class of immunoglobulins. The monoclonal antibodies are useful as basic diagnostics for detecting human prostate cancer cells.

Abstract: Three new monoclonal antibodies, MU78, MT334, and MQ49, and the hybridoma cell lines producing these, are disclosed. The antibodies specifically bind to mucin-like antigens with distribution over various carcinomas.