Abstract: Provided are a multiple immunoassay apparatus on a chip in which a structure comprising multiple microfluidic channels is associated with a tissue sample, which allows immunohistochemical reactions to be conducted therein, to examine various markers specific for certain diseases, and a method for performing multiple immunoassays using the same. The multiple immunoassay apparatus comprises: at least one antibody-introducing unit through which at least one antibody is introduced into the apparatus; at least one reaction unit in which the antibody reacts with a sample in an immunohistochemical pattern; and at least one fluid outlet through which a fluid including the antibody is discharged outside the apparatus.

Abstract: The present invention provides and includes monoclonal antibodies (MoAbs or mAbs) specific or preferentially selective for PCBP-1 antigens, hybridoma lines that secrete these PCBP-1 antibodies or antibody fragments, and the use of such antibodies and antibody fragments to detect PCBP-1 antigens, particularly those expressed by cancer cells. The present invention also includes antibodies that are specific for or show preferential binding to a soluble form of PCBP-1. The present invention further includes chimeric and humanized antibodies, processes for producing monoclonal, chimeric, and humanized antibodies using recombinant DNA technology, and their therapeutic uses, particularly in the treatment or diagnosis of cancer progression. The present invention further includes methods and kits for the immunodetection and immunotherapy of cells for samples which express PCBP-1 antigens.

Abstract: Methods and reagents for classifying HER2+ breast tumors and for identifying new HER2+ breast tumor classes and subclasses. Methods for correlating tumor class or subclass with therapeutic regimen or outcome, for identifying appropriate (new or known) therapies for particular classes or subclasses, and for predicting outcomes based on class or subclass. New therapeutic agents and methods for the treatment of HER2+ breast cancer.

Abstract: This invention provides antibodies immunologically specific for human ARL-1 (also referred to AKR1B10), a species of the aldo-keto reductase superfamily of proteins. The invention also provides methods of making and methods of using said antibodies.

Abstract: A plurality of kinds of liquids, which are of at least three kinds, containing (a) a test body solution containing at least one kind of an analyte, and (b) at least two kinds of liquids selected from the group consisting of a reagent solution, an amplifying solution, and a detecting solution, are fed to a detection site containing a specific binding substance with respect to the analyte. A qualitative analysis or a quantitative analysis of the analyte contained in the test body solution is thereby performed. Directions of liquid feeding of all of the plurality of the kinds of the liquids vary from one another, and the plurality of the kinds of the liquids are caused to intersect with one another at the detection site.

Abstract: The present invention provide reagents and methods of using the reagents, for example, on automated staining devices, that facilitate detection of two or more antigens in a sample simply and efficiently.

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: A method for determining the presence or amount of a metal-labelled analyte (12) in a sample is described. The method comprises the steps of adding a release agent (20) to the metal labelled analyte (12) to release the metal label (18) from the analyte (12), the release agent (20) forming a charged stable species (22) with the metal label (18), applying a potential to bring the charged stable species (22) to an electrode (22), dissolving the charged stable species (22) under a positive potential to form metal ions (26), and carrying out a quantitative determination procedure such as anodic stripping voltammetry to determine the presence or amount of the metal-labelled analyte (12).

Abstract: An object of the present invention is to provide a method for inhibiting activation of signaling pathway mediated by erbB1 or erbB2 in human cell and a signaling inhibitor to be used therefor. The above-described activation of signaling pathway can be inhibited by a polypeptide comprising at least one of PTB domain or ERK2 binding domain of human FRS2?. The above-described polypeptide may be introduced directly into cell, or nucleic acid which encodes for the above-described polypeptide may be introduced into cell to allow expression of the polypeptide in the cell. Such polypeptide and nucleic acid can be used, for example, as a signaling inhibitor. In addition, since erbB1 and erbB2 are involved in development of cancer, the above-described signaling inhibitor is also useful, for example, as an anticancer drug.

Abstract: This invention provides antibodies immunologically specific for human ARL-1 (also referred to AKR1B10), a species of the aldo-keto reductase superfamily of proteins. The invention also provides methods of making and methods of using said antibodies.

Abstract: A method of in situ immunohistochemical analysis of a biological sample is provided. The method allows for the multiplex and simultaneous detection of multiple antigens, including multiple nuclear antigens, in a tissue sample.

Abstract: A method to facilitate recovery troponin I and/or troponin T from a sample comprising addition of troponin C to the sample or to a surface from which the troponin I and/or troponin T are recovered.

Abstract: It is an object of the present invention to provide a measurement kit for developing a first developing solution and a second developing solution from different directions to suppress background noise, and an immunochromatography kit. The present invention provides a measurement kit, which comprises a first developing member for supplying a first developing solution and a second developing member for supplying a second developing solution, wherein the developing direction of the first developing solution is allowed to intersect with the developing direction of the second developing solution, so that development is carried out by developing the first and second developing solutions in different developing directions, and a water absorbent portion is established on the downstream of the developing directions.

Abstract: The present invention provides sets of genes the expression of which is important in the prognosis of cancer. In particular, the invention provides gene expression information useful for predicting whether cancer patients are likely to have a beneficial treatment response to chemotherapy FHIT; MTA1; ErbB4; FUS; BBC3; IGF1R; CD9; TP53BP1; MUC1; IGFBP5; rhoC; RALBP1; STAT3; ERK1; SGCB; DHPS; MGMT; CRIP2; ErbB3; RAP1GDS1; CCND1; PRKCD; Hepsin; AK055699; ZNF38; SEMA3F; COL1A1; BAG1; AKT1; COL1A2; Wnt.5a; PTPD1; RAB6C; GSTM1, BCL2, ESR1; or the corresponding expression product, is determined, said report includes a prediction that said subject has a decreased likelihood of response to chemotherapy.

Abstract: The present invention relates to novel methods and compositions useful for detecting whole parathyroid hormone at a physiological level and parathyroid fragments in a mammalian sample. Such detections may be useful to different parathyroid diseases or disorders in a subject, such as hyperparathyroidism and related bone diseases, from normal or non-disease states. One detects whole or non-fragmented (1 to 84) parathyroid hormone in a biological sample and optionally one or more of a selection of non-whole parathyroid hormone peptide fragments that may or may not function as a parathyroid hormone antagonists. By either comparing values or using independently the value of either the one or more of a selection of non-whole parathyroid hormone peptide fragments, the whole parathyroid hormone, or the combination of these values one is able to differentiate parathyroid and bone related disease states, as well as differentiate such states from normal states.

Abstract: A method of analyzing a sample for one or more analytes of interest includes: providing an element having a base layer; a layer containing streptavidin; a spreading layer, wherein the streptavidin may or may not be in the spreading layer; providing immunocomponents and labeled immunoreactants which may be in the spreading layer or may be combined with the sample; dispensing the sample, and optionally the immunocomponents and a labeled immunoreactant onto the spreading layer at three or more areas, wherein each center of the three or more areas is substantially equidistance to the center formed by the three or more areas, and wherein each area contacts an adjacent area such that wash fluid flow in any direction will contact sample; washing the sample and label by directing the wash fluid at the center formed by the three or more areas, whereby the wash fluid equally flows over each of the three or more areas; and taking a measurement at each three or more areas to determine the presence or concentration of the

Abstract: A method for the determination of a target analyte in a sample, said method comprising: a) applying a liquid sample suspected of containing said target analyte to a solid support capable of allowing lateral flow of liquid there through, which support has diffusibly arranged thereon, (i) either (a) a labeled binding partner for said analyte or (b) a labeled analogue of said analyte, and (ii) a labeled control reagent; b) allowing the sample, labeled binding partner for said analyte or a labeled analogue of said analyte and labeled control reagent to flow through a detection zone on said solid support; c) allowing the sample, labeled binding partner for said analyte or a labeled analogue of said analyte and labeled control reagent to flow through a control zone; and d) detecting the labeled density in the detection zone and the label density in the control zone and comparing these densities.

Abstract: The invention relates to a device for detecting one or several analytes in a sample, characterized in that it comprises one or more reaction chambers and/or one or more reagent application channels, and one or more capillary systems and one or more negative vessels. The invention also relates to a method for detecting one or more analytes in a sample fluid by visualization of agglutination, characterized in that a) the sample fluid is brought into contact with a reagent, b) the reaction mixture is exposed to the effects of gravitation or magnetism, wherein the reaction mixture is strained through the capillary system of the inventive device with a negative vessel connected to the inventive device, and c) the reaction between the analyte and the reagent is determined. The invention also relates to one such method wherein the reaction mixture is brought into contact with another reagent during step b).

Abstract: Described is a method for discriminating complex biological samples using an array of discrete biological sensing elements immobilized onto a solid support in which constituents bound to the sensor array is directly determined by measuring the mass increase on the surface; data analysis of said method is performed using neutral network or statical based pattern recognition techniques. In a preferred embodiment the liquid sample is tested for the presence of soluble constituent(s) by contacting said sample with said sensor array under specific conditions, removing unbound sample constituent(s), determining the mass increase on the surface and comparising said mass increase data with a reference standard using pattern recognition software.

Abstract: A lagomorph derived monoclonal antibody for recognizing the progesterone receptor (PR) (clone SP2) with immunohistochemistry and methods for creating such an antibody are disclosed. No need of target retrieval in immunohistochemistry is their prominent advantage compared to currently available PR antibody. Furthermore, the very low background when the lagomorph derived monoclonal antibody is used in immunohistochemistry is also impressive. The immunohistochemistry comparative study with about fifty clinical specimens showed that the new PR antibody (clone SP2) antibody had favorable results when compared to mouse monoclonal antibody PR (clone 1A6), the best one in the current market. The PR antibody may prove of great value in the assessment of PR status in human breast cancer. Humanized versions of the PR antibody may provide therapeutic benefits.

Abstract: Methods for detecting atherosclerotic plaque and quantifying the amount of Group V sPLA2 in plasma are disclosed. These methods can be used to assess the risk of cardiovascular pathology in a patient.

Abstract: A method and test device for differentiating between states of an analyte that can exist in different forms, such as follicle stimulating hormone (FSH). The method or test device uses a pair of specific binding agents, especially monoclonal antibodies, in two assays for the same analyte. The assays, applied to contemporaneous samples, differ from one another in format, one being a two step assay and the other being one step. A novel pair of anti-FSH monoclonal antibodies that can be used together in two such assays to differentiate pre-menopausal and post-menopausal FSH samples is disclosed.

Abstract: The invention relates to a technology by which antibodies directed to sources of infection in body fluids can be assayed with high accuracy, expediency and specificity. More particularly, the invention provides an antibody immunoassay method in which the antigen-antibody reaction between a target antibody in a sample and an assay antigen is conducted in the presence of an E. coli component and an antibody assay method which comprises using a reagent having a specific affinity for the Fc region of an antibody IgG as the antibody assay reagent.

Abstract: The present invention is directed to directly measure distribution in vivo and the frequency of generation in vivo of DNA strand breaks which induce cell death and mutations. The present inventors accomplished the present invention by providing a method for detecting a DNA strand break in a sample, which comprises a step of binding a PprA protein derived from Deinococcus radiodurans to a DNA strand break and a step of detecting the PprA protein which is bound to the DNA strand break; as well as by providing a kit for detecting a DNA strand break in a sample which comprises PprA proteins derived from Deinococcus radiodurans and a means for detecting a PprA protein which is bound to a DNA strand break.

Abstract: We disclose methods of sorting or separating mixtures of living cells (e.g., eukaryotic, prokaryotic, mammalian, pathogenic, bacterial, viral, etc.). We perform our methods by activating cell-selective photophoric labels, which photosensitize and chemically reduce a photosensitive metal compound to form metal grains, particles or crystals. The metal adheres to the cells and forms the basis for sorting or separating different cell types. Photophoric labels may include chemiluminescent agents such as peroxidase enzymes activated with peroxidase substrates capable of luminescence. Photosensitive metal compounds may be present in a light-sensitive matrix or emulsion containing photosensitizable metal compounds, which form metal grains, particles or crystals upon exposure to a developer solution. Developer solutions are formulated to substantially allow living cells to remain viable after exposure to the developing solution.

Abstract: The present invention relates to compositions and methods for cancer diagnostics, including but not limited to, cancer markers. In particular, the present invention provides gene expression profiles associated with prostate cancers. The present invention also provides novel markers useful for the diagnosis, characterization, and treatment of prostate cancers. In particular, the present invention provides methods and compositions for the detection of ?-methylacyl-CoA racemase (AMACR) in the urine as a marker for prostate cancer detection.

Abstract: The present invention provides a process of screening patients for atopic dermatitis. The process includes the step of determining, in sera of the patient, the presence of antibodies against nuclear antigens such as transcription co-activator p75, wherein the presence of such antibodies indicates atopic dermatitis. The screening process can be used to detect atopic dermatitis in patients suffering from other conditions such as asthma or interstitial cystitis.

Abstract: Various antibodies with different binding characteristics for MBL A or MBL B bound to mannan or MBL A or MBL B bound to an antibody against MBL are provided. Also provided are methods for selecting antibodies against MBL with different binding characteristics and methods and kits for using these antibodies to measure MBL capable of binding to mannan or oligomerized MBL and abnormal, poorly oligomerized MBL in a sample. The methods and kits are useful in diagnosing increased susceptibility to and exacerbation of infections and autoimmune diseases.

Abstract: High affinity monoclonal antibodies for recognizing estrogen receptor (clone SP1) with immunohistochemistry and methods for creating such an antibody are disclosed. The lagomorph derived ER antibody provides a significant advantage over the currently available mouse ER antibodies in that there is no need for target retrieval when performing immunohistochemistry. Furthermore, the very low background when the lagomorph derived ER antibody is used in immunohistochemistry is also impressive. The immunohistochemistry comparative study with about fifty clinical specimens showed that the new ER (clone SP1) antibody had favorable results when compared to mouse monoclonal ER antibodies (clone 1D5). The lagomorph derived ER antibody may prove of great value in the assessment of ER status in human breast cancer. Humanized versions of the ER antibody may also provide therapeutic benefits.

Abstract: A method and kit of diagnosing endometriosis in a female patient suspected of having endometriosis. The method includes obtaining a sample from the patient. The sample is analyzed to detect the presence of a purified and isolated endometriotic haptoglobin designated ENDO-I and functional analogs thereof. A therapeutic for treating endometriosis by modulating the expression of a purified and isolated endometriotic haptoglobin designated ENDO-I and functional analogs thereof and a pharmaceutically acceptable carrier.

Abstract: Optical bio-discs for biochemical analysis, bio-disc analysis systems and biochemical analysis methods are described herein. In one embodiment, the bio-disc includes a sample analysis circuit that includes a separation membrane for separating an investigational feature of a sample. The bio-disc also includes a conjugate release pad, and an analysis membrane containing analysis zones that may be analyzed for the presence of analytes. An analysis method includes providing a sample to a separation membrane in a bio-disc, separating an investigational feature from the sample using a separation membrane, mixing reagents that include signal elements for detecting an analyte with the investigational feature so as to form a reagent-investigational feature mixture and capturing an analyte with a signal element bound thereto in an analysis zone on an analysis membrane.

Abstract: Monocolonal antibodies having a higher reactivity with tartrate-resistant acid phosphatase 5b (TRACP 5b) than tartrate-resistant acid phosphatase 5a (TRACP 5a) and having a higher specificity to TRACP 5b can be obtained by cell fusion using as antigens TRACP 5b purified from human osteoclasts. By using the monoclonal antibody, TRACP 5b in a sample can be detected specifically with a high sensitivity.

Abstract: A novel monoclonal antibody which specifically binds to apo-B-48 is disclosed. The monoclonal antibody specifically binds to apo-B-48 but does not bind to apo-B-100.

Abstract: A family of cDNA sequences derived from hepatitis C virus (HCV) are provided. These sequences encode antigens which react immunologically with antibodies present in individuals with non-A non-B hepatitis (NANBH), but which are absent from individuals infected with hepatitis A virus, or hepatitis B virus, and also are absent in control individuals. The HCV cDNA sequences lack substantial homology to the sequences of hepatitis delta virus (HDV) and HBV. A comparison of the sequences of amino acids encoded in the HCV cDNA with the sequences of Flaviviruses indicates that HCV may be related to the Flaviviruses. The HCV cDNA sequences and the polypeptides encoded therein are useful as reagents for the detection and therapy of HCV. The reagents provided in the invention are also useful for the isolation of NANBH agent(s), for the propagation of these agents in tissue culture, and for the screening of antiviral agents for HCV.

Abstract: A gelatin-based substrate for fabricating protein arrays, the substrate comprising: gelatin having at least one surface; a polymer scaffold affixed to the gelatin surface; wherein the polymer in the scaffold is rich in reactive units capable of immobilizing proteins.

Abstract: Disclosed are a spectrofluorimetrically detectable luminescent composition and processes for enhancing the luminescence of one or more lanthanide-containing macrocycles. The luminescent composition comprises a micelle-producing amount of at least one surfactant, at least one energy transfer acceptor lanthanide element macrocycle compound having an emission spectrum peak in the range from 500 to 950 nanometers, and a luminescence-enhancing amount of at least one energy transfer donor compound of yttrium or a 3-valent lanthanide element having atomic number 59-71, provided that the lanthanide element of said macrocycle compound and the lanthanide element of said energy transfer donor compound are not identical. The addition of gadolinium(III) in the presence of other solutes to both the prototype and the di-functionalized europium, samarium, and terbium macrocyclic complexes, which were taught in our U.S. Pat. Nos. 5,373,093 and 5,696,240, enhances their luminescence.

Abstract: A method for quantitating cellular proteins in tissue, by means of a cell imaging densitometer in conjunction with immunohistological staining and a reference standard, is provided. Unlike prior art methods, which provide ordinal measures of relative amounts of protein among different cells, the method enables the quantitation of antigenic proteins in terms of absolute mass of protein/tumor or protein/patient, molecules of protein per cell, and volume or fraction of a tissue sample expressing the protein of interest. The method is useful for research purposes in the study of protein expression, and is shown to improve the accuracy of clinical histopathological analysis of tumor tissue sections for diagnosis and prognosis. The method is expected to be useful for prescribing in situ treatment dosages.

Abstract: The invention relates to a method and a kit for the diagnosis of endometriosis using blood and endometrial leukocyte markers or a combination thereof. The marker is a surface antigen from endometrial or blood leukocytes.

Abstract: A kit containing the reagents necessary for the qualitative or quantitative demonstration of epidermal growth factor receptor (EGFR) in formalin-fixed, paraffin-embedded tissue sections. A immunohistochemical staining procedure is employed which utilizes a primary monoclonal mouse antibody that selectively binds to EGFR. The primary antibodies bound to tissue antigens are detected using a peroxidase labeled polymer that is conjugated with secondary anti-mouse immunoglobulin antibodies. The enzymatic conversion of the subsequently applied chromogen results in formation of a visible reaction product at the site of the EGFR antigen. Following development of the chromogen, specimens may then be counterstained and coverslipped. Results are interpreted using a light microscope or other optical imaging device. The detection system is adapted for both manual and automated staining.

Abstract: A monoclonal antibody binding selectively to neurosin obtained from hybridomas, in particular, strain 2B2-6 and strain S2E5 showing stable proliferation ability. These hydridomas are obtained by fusing mouse spleen cells having a high antibody titer against neurosin with mouse-derived myeloma cells, screening fused cells being highly reactive with neurosin, and thus producing an antibody binding specifically to neurosin. By using this antibody, various diseases in which neurosin participates can be diagnosed.

Abstract: A method of diagnosing an autoimmune disease is disclosed which involves determining whether autoantibodies from a body fluid react with a microtubule organizing center (MTOC). This diagnostic procedure provides a simple, highly specific, and highly reliable diagnosis of autoimmune disease, including rheumatoid arthritis.

Abstract: The invention relates to a complex of enzyme, protein and carrier comprising two or more molecules of an enzyme conjugated through amino group or other group to a carrier such as polylysine, and a protein (for example, antibody) with a specific binding potency to other substance(s) (for example, antigen) conjugated to at least one of said two or more molecules of the enzyme, which enables accurate assay of a trace amount of a substance at a high sensitivity.

Abstract: The invention provides heterobifunctional cross-linking reagents and methods of using the cross-linking reagents. The cross-linking reagents of the invention combine a nucleophilic hydrazide residue with an electrophilic maleimide residue allowing coupling of aldehydes to free thiols. In the methods of the invention, human immunodeficiency virus (HIV) infected cells can be detected using conjugates that include CD4 molecules conjugated to detectable markers via the disclosed cross-linking reagents.

Abstract: A heating device for heating biological specimens is comprised of an electric pressure cooker with a pressure gauge, and a temperature sensor connected to a controller with a temperature display and a temperature alert. The controller is arranged to heat the specimen at a selectable temperature for a selectable time period. The quality control process is comprised of placing in the cooker a heat sensitive pH indicating retrieval solution, and a heat and pressure sensitive steam strip. When the set temperature has been reached, the actual temperature and pressure are recorded. When the cooker is opened after heating, the pH indicating solution is checked for color change that indicates a pH change, and the steam strip is checked for color change that indicates predetermined temperature and pressure levels have been reached.

Abstract: Methods and compositions are described for the detection and quantitation of cardiac specific troponin I and troponin T in samples. Cardiac-specific troponin isoforms exist in various forms in the blood, including free and complexed forms. By selecting antibodies that are sensitive and/or insensitive to these various forms, the present invention can provide immunoassays that more accurately reflect the clinical state of an individual. These described methods and compositions can be used for providing indicators of myocardial infarction and other cardiac pathologies.

Abstract: This invention relates to the discovery of the association of certain nucleic acid sequences and proteins with breast cancer, the use of such sequences as a diagnostic indicator and treatments based on the association.

Abstract: A method for evaluating sperm quality is disclosed. The first step of the method is to obtain a quantity of sample mammalian sperm and a sample of mature mammalian oocytes. The oocytes are fertilized with the sperm and the cumulus cells are removed from the fertilized oocytes. The oocytes are then labelled with antibodies directed to microtubules and the labelled microtubules are observed microscopically. The microtubule pattern is evaluated for microtubule aster size and organization. In one preferred from of the present invention, the mammalian sperm and mammalian oocytes are of the same species. In another preferred form of the present invention, the mammalian sperm and oocytes are of different species.

Abstract: The present invention features calcilytic compounds. “calcilytic compounds” refer to compounds able to inhibit calcium receptor activity. Also described are the use of calcilytic compounds to inhibit calcium receptor activity and/or achieve a beneficial effect in a patient; and techniques which can be used to obtain additional calcilytic compounds.

Abstract: A method of distinguishing prostate cancer from benign prostatic hyperplasia (BPH) is provided. The mathematical combination or ratio of proPSA and BPSA serum or tissue markers may be used for distinguishing benign prostatic hyperplasia (BPH) from prostate cancer. It is the discovery of the present invention that BPSA is preferentially elevated in transition zone prostate tissue whereas pPSA is elevated in the peripheral zone of prostate tissue. A kit for aiding in distinguishing BPH from prostate cancer is also provided.

Abstract: Methods and kits for simultaneously measuring both members of a binding pair are described.