Abstract: Disclosed herein is a method of detecting and identifying antigens that are shed into human bodily fluids during infection. The disclosed method allows circulating antigens associated with a particular infection to be detected within minutes or hours from testing as compared to days required with the current methods. Methods of identifying diagnostic indicators/targets for a given condition or disease are disclosed which include immunizing a verterinary subject with biological fluids obtained from a human infected with particular antigens to identify diagnostic targets for immunoassay. Also disclosed are methods of diagnosing and monitoring a B. pseudomallei-associated condition, such as melioidosis. Point-of-care immunoassays are also provided that can be used to diagnose or monitor the efficacy of a B. pseudomallei-associated condition treatment. These immunoassays can also be used for rapid diagnosis of infection produced by B. pseudomallei, such as meliodosis.

Abstract: The present invention relates to methods and compositions for monitoring, diagnosis, prognosis, and determination of treatment regimens in subjects suffering from or suspected of having a renal injury. In particular, the invention relates to using a plurality of assays configured to detect a kidney injury marker as diagnostic and prognostic biomarkers in renal injuries.

Abstract: Methods for diagnosing cancer in a subject are disclosed. The method includes detecting the level of expression of one or more cancer markers in a biological sample obtained from the subject; and comparing the level of expression of the one or more cancer markers in the biological sample to a normal level of expression of the one or more cancer markers. The one or more cancer markers comprises CXCL13 or CXCR5 or both CXCL13 and CXCR5. Also disclosed is a kit for detecting cancer or monitoring cancer progression.

Abstract: The present invention relates to a method aiding in the assessment of colorectal cancer. The method especially is used in assessing the absence or presence of colorectal cancer in vitro. The method is for example practiced by analyzing biochemical markers, comprising measuring in a stool sample the concentration of the hemoglobin/haptoglobin complex and calprotectin and correlating the concentrations determined to the absence or presence of colorectal cancer. To further improve the assessment of colorectal cancer based on a method of this invention the level of one or more additional marker may be determined together with the hemoglobin/haptoglobin complex and calprotectin in a stool sample and be correlated to the absence or presence of colorectal cancer. The invention also relates to the use of a marker panel comprising the hemoglobin/haptoglobin complex and calprotectin in the early diagnosis of colorectal cancer and it teaches a kit for performing the method of the invention.

Abstract: A novel class of embryo derived peptides are described (Preimplantation factor) that were generated synthetically and were tested on peripheral blood immune cells and shown to block activated but not basal immunity, inhibiting cell proliferation and creating a TH2 type cytokine bias, in addition PIF enhance endometrial receptivity by increasing adhesion molecules expression. PIF biological activity appears to be exerted by specific binding to inducible receptors present on the several white cell lineages. PIF peptides, which are immune modulators therefore may have diagnostic and non toxic therapeutic applications in improving fertility, reducing pregnancy loss as well may be useful when administered for the treatment of autoimmune diseases and for prevention xenotransplants rejection.

Abstract: Provided herein are antibodies and methods of using the antibodies to treat and diagnose neurite degenerative diseases and disorders.

Abstract: The present invention provides compositions and methods for detection schemes for ascertaining pregnancy status of an animal. The compositions and methods employ interferon-tau (IFNT) and/or antibodies specific for IFNT. Methods of the present invention detect the presence of IFNT in samples obtained from animals as an early indicator of pregnancy. Methods are provided to identify non-pregnant animals so that management decisions regarding rebreeding can be made earlier compared to existing approaches.

Abstract: The present invention relates to a method for the diagnosis and/or prognosis and/or assessment and/or therapy stratification of syncope in a patient the method comprising: determining the level of at least one biomarker selected from the group consisting of proET-1, pro ADM, proANP, proBNP, proAVP and PCT or a fragment of at least 12 amino acids thereof, in a sample of a bodily fluid of said patient, correlating said level of at least one biomarker or fragments thereof with the diagnosis and/or prognosis and/or assessment and/or therapy stratification of syncope.

Abstract: Markers useful in diagnosing disseminated intravascular coagulation (DIC) or infectious DIC are provided. In a method for detecting DIC of the present invention, sCD14-ST in a sample is measured. In a method of detecting infectious DIC of the present invention, sCD14-ST and a coagulation-related marker in a sample are measured.

Abstract: A method of bioassay for the quantification of peptide fragments comprising a neo-epitope formed by cleavage ofmimecan, a protein of an atherosclerotic plaque, by a proteinase, said comprises contacting a sample such as urine or serum with an antibody reactive with the neo-epitope and determining the level of binding of said immunological binding partner to peptide fragments in said sample. The assay is predictive of risk of cardiovascular disease events.

Abstract: Disclosed is an immunoassay method whereby a 5.9 kDa peptide which results from the degradation of the ?-E chain and ? chain of human fibrinogens and which is used as a peptide marker for diagnosing hepatic disease can be specifically assayed in a biological sample containing contaminating peptides by bringing antibodies that recognize the N terminal of said peptide marker and antibodies that recognize the C terminal of said peptide marker into contact with said peptide marker, forming immune complexes of said peptide marker and the two antibodies, and immunoassaying the obtained immune complexes.

Abstract: The invention provides a method for detecting heparin-induced antibodies comprising a) binding a PF4-heparin antigen to a solid surface; b) incubating the bound PF4-heparin with a sample comprising heparin-induced antibodies to be detected; c) contacting the sample with at least two labeled secondary antibodies, wherein the secondary antibodies bind to heparin-induced antibodies present in the sample; d) detecting the presence of the labeled secondary antibodies using flow cytometry or a suitable method, wherein the heparin-induced antibodies bound to the secondary antibodies are identified. In one embodiment, the at least two secondary antibodies are anti-human antibodies which specifically bind to heparin-induced antibodies and are selected from the group consisting of Ig, IgG, IgA, and IgM.

Abstract: The present invention relates to compositions, kits, and methods for providing a prognosis and/or determining a treatment course of action in a subject diagnosed with breast cancer. In particular, the present invention relates to gene expression signatures useful in the prognosis, diagnosis, and treatment of breast cancer.

Abstract: Provided are a monoclonal antibody capable of specifically recognizing a specific region of sAPP ? or a fragment of said antibody and an assay method and an assay kit using the same, in order to accurately assay sAPP? contained in a biological sample.

Abstract: This document features methods of evaluating mammals by assessing expression of B7-H1 in a body fluid.

Abstract: Methods, assays, and kits for determining a cancer's (e.g., breast cancer) metastatic potential and tumor aggressiveness in a subject (e.g., a human patient) and for measuring a subject's response to cancer therapy involve analyzing expression of Sema7A in a biological sample from the subject, and correlating increased expression of Sema7A in the biological sample compared to a control sample with metastatic potential of the cancer, wherein the expression of Sema7A is linearly proportional to the metastatic potential of the cancer in the subject. These methods, kits and assays provide for individualized diagnosis and treatment options for cancer (e.g., breast cancer) patients. They can be used independently, or can be combined with additional diagnostic tests and/or prognostic methods. Compositions, kits and methods for treating a subject having cancer (e.g., breast cancer) include administering a composition for inhibiting Sema7A expression or activity to the subject.

Abstract: The present invention relates to antibodies against Oncofetal Antigen/immature Laminin receptor protein (OFA/iLRP) that can be used singly or in conjunction to detect or treat OFA/iLRP-related diseases. More specifically, the antibodies can be used for several purposes including: (i) detecting and measuring OFA/iLRP in different biofluids; and (ii) using OFA/iLRP with an antibody directed against the monomeric form and its associated diseases.

Abstract: The present disclosure provides methods and/or kits for detecting an analyte in a sample. Some embodiments provide a method for detecting a non-nucleic acid analyte in a sample using a solid substrate comprising a bound immobilization agent and an antibody capture agent and a detectable agent, which can bind to the analyte. The antibody capture agent comprises, at a plurality of sites, a ligand for the immobilization agent. A complex between the analyte, the antibody capture agent and a detectable agent is formed and immobilized on the solid substrate by binding between the immobilization agent and the ligand. In some embodiments, the ligand and the immobilization agent are a binding pair comprising a peptide tag and an anti-peptide tag antibody.

Abstract: Methods and compositions are disclosed for determining feline proBNP or fragments thereof in a sample. In one method, feline proBNP or fragments thereof are determined by providing a feline sample, contacting the sample with at least one antibody that binds an epitope in the region from amino acids 68 to 80 of feline proBNP, and determining the presence of the feline proBNP or fragments thereof present in the sample. Antibodies that bind feline proBNP and kits comprising such antibodies are also disclosed.

Abstract: The present invention relates to methods and compositions for monitoring, diagnosis, prognosis, and determination of treatment regimens in subjects suffering from or suspected of having a renal injury. In particular, the invention relates to using a one or more assays configured to detect a kidney injury marker selected from the group consisting of Angiopoietin-related protein 3, Soluble Lymphatic vessel endothelial hyaluronic acid receptor 1, and Vascular endothelial growth factor D as diagnostic and prognostic biomarkers in renal injuries.

Abstract: The present invention relates to antibodies anti-sPLA2-IIA and uses thereof.

Abstract: The present invention aims to diagnose rheumatoid arthritis more accurately and rapidly, and relates to a method and a kit for diagnosing rheumatoid arthritis, based on the detection of citrullinated autoantigens in a test sample.

Abstract: Methods and systems for diagnosing functional and/or structural abnormalities of the heart preceding heart failure, and for predicting the risk of developing heart failure, in a subject comprising measuring a cardiac troponin in a sample and comparing the measurement to a reference value. Other markers, including GDF15 and IGFBP7 are also measured in some embodiments.

Abstract: One aspect of the present disclosure relates to a calorimeter for detecting the presence of a target analyte in a fluid sample. The calorimeter can include a substrate, a hermetically-sealed, thermally decoupled central reaction zone associated with the substrate, at least one droplet transport region, and detection electronics. The at least one droplet transport region can be associated with the substrate and configured to merge a reagent droplet with a sample droplet including the fluid sample to form a reaction droplet in the central reaction zone. The detection electronics can be in electrical and/or thermal communication with the central reaction zone and associated with the substrate. The calorimeter can be configured to detect a heat of reaction produced by a reaction event between the target analyte and a capture reagent upon formation of the reaction droplet.

Abstract: A method of evaluating a probability a subject has a cancer, diagnosing a cancer and/or monitoring cancer progression comprising: a. measuring an amount of a biomarker selected from the group consisting of CUZD1 and/or LAMC2 and/or the group CUZD1, LAMC2, AQP8, CELA2B, CELA3B, CTRB1, CTRB2, GCG, IAPP, INS, KLK1, PNLIPRP1, PNLIPRP2, PPY, PRSS3, REG3G, SLC30A8, KLK3, NPY, PSCA, RLN1, SLC45A3, DSP, GP73, DSG2, CEACAM7, CLCA1, GPA33, LEFTY1, ZG16, IRX5, LAMP3, MFAP4, SCGB1A1, SFTPC, TMEM100, NPY, PSCA, RLN1 and/or SLC45A3 in a test sample from a subject with cancer; wherein the cancer is pancreas cancer if CUZD1, LAMC2, AQP8, CELA2B, CELA3B, CTRB1, CTRB2, GCG, LAPP, INS, KLK1, PNLIPRP1, PNLIPRP2, PPY, PRSS3, REG3G, SLC30A8, DSP, GP73 and/or DSG2 is selected; the cancer is colon cancer if CEACAM7, CLCA1, GPA33, LEFTY1 and/or ZG16 is selected, the cancer is lung cancer if IRX5, LAMP3, MFAP4, SCGB1A1, SFTPC and/or TMEM100 is selected; or the cancer is prostate cancer if NPY, PSCA, RLN1 and/or SLC45A3 is selected; b.

Abstract: The present invention provides methods and systems to predict and diagnose inflammatory bowel disease (IBD) and subtypes such as ulcerative colitis (UC) and Crohn's disease (CD) by detecting the presence, absence, level, and/or genotype of one or more sero-genetic-inflammation markers. Advantageously, with the present invention, it is possible to provide a diagnosis of IBD versus non-IBD, to rule out IBD that is inconclusive for CD and UC, and to differentiate between CD and UC with increased accuracy.

Abstract: Embodiments of the invention include methods for detecting and determining the concentrations of macro and small molecules, including bio-molecules, in a liquid or gaseous sample.

Abstract: Definitive diagnosis and early start of treatment cannot be made for tuberculosis since conventional methods for detecting a Mycobacterium tuberculosis complex require a long time plus enormous labor and expense. Because detection is difficult to perform directly from a biological sample, if the biological sample contains no or a very small amount of MPT64, there is a risk infection with the Mycobacterium tuberculosis complex will be missed. The present method and a kit address these long-standing needs by more rapidly and conveniently detecting a Mycobacterium tuberculosis complex, without culturing a biological sample containing the Mycobacterium tuberculosis complex, in which a biological sample is subjected to a heat-treatment so as to extracellularly secrete a Mycobacterium tuberculosis complex-specific secretory protein, particularly, MPB64, and subjecting the resulting treated sample to an immunological measurement/assay.

Abstract: This invention provides methods and kits for improved diagnosis of medically relevant conditions by solution based biochemical testing procedures performed in solutions of test samples. The invention provides a method to substitute the cell based morphological information contained within the cytological and/or histological data of the test sample by molecular information obtainable from the solution, wherein the original test sample is dissolved and thus enables for accurate and reproducible assessment of medically relevant diagnosis from dissolved test samples. The method according to the invention comprises the steps of determining the levels of one or more disease markers associated with the condition to be diagnosed, determining the level of one or more normalization markers suitable to substitute the information related to morphological aspects of the sample, comparing and/or combining the data of the disease and normalization markers, and assessing diagnosis of a medically relevant condition.

Abstract: Provided is a humanized or chimeric antibody or fragment thereof capable of binding to interleukin-10 (1L-10), wherein said antibody or fragment thereof is capable of being administered to a subject in the absence of an intolerable increase in the level of pro-inflammatory cytokines. Further provided are methods of treatment involving the use of the antibody or fragment thereof.

Abstract: Compositions and methods comprising proteins that bind specifically to adalimumab are disclosed herein. Adalimumab is a monoclonal antibody specific for the cytokine TNF-? and was developed to treat TNF-? mediated inflammatory diseases. In one aspect of the instant invention, the binding proteins are antibodies directed toward adalimumab. These antibodies, including binding fragments thereof, can be used in a clinical setting as well as for research and development. For example, these anti-adalimumab antibodies can be employed to neutralize adalimumab.

Abstract: Provided is a microanalysis method and system using a Field Effect Transistor (FET). The microanalysis method includes a channel region having a receptor molecule fixed; forming a nano-particle conjugate in the channel region by supplying a sample for test and the nano-particle conjugate to the FET; growing a probe material on the channel region; and measuring a current flowing through the channel region, wherein the receptor molecule is a material that is selectively bonded to a target molecule in the sample for test.

Abstract: The present invention relates to methods and compositions for monitoring, diagnosis, prognosis, and determination of treatment regimens in subjects suffering from or suspected of having a renal injury. In particular, the invention relates to using assays that detect Trefoil factor 3 as diagnostic and prognostic biomarker assays in renal injuries.

Abstract: The present invention includes compositions and methods for the diagnosis and treatment of lung cancer with a recombinant tumor-associated antigen loaded antigen presenting cell that generates a cytotoxic T lymphocyte specific immune response to at least one of SP17, AKAP-4, or PTTG1 expressed by one or more lung cancer cells.

Abstract: An in vitro method aiding in the assessment of chronic obstructive pulmonary disease (COPD). The disclosure further relates to a method for assessing COPD from a sample, derived from an individual, by measuring the protein ARMET in said sample in vitro.

Abstract: The invention relates to methods of diagnosing the severity of heart failure or a cardiac dysfunction in a subject. The invention further relates to monitoring the severity of heart failure in a subject and determining the prognosis of a subject that has suffered from heart failure. This invention also relates methods to identify patients at risk for cardiac dysfunction when exposed to cardiotoxic chemotherapy agents.

Abstract: The present invention provides a method of detecting dermatophyte, which does not require a complicated operation such as an enzyme treatment and a heat treatment. The present invention provides a method of detecting dermatophyte, including a step of extracting a dermatophyte component from a sample with a treatment liquid containing a non-ionic surfactant or a zwitterionic surfactant, and a kit for diagnosing dermatophyte infection, containing a treatment liquid comprising the above surfactant, and an antibody specifically recognizing a dermatophyte component, which are housed in separate containers.

Abstract: An object of the present invention is to provide a biomarker that can be used as a precise diagnostic marker for MetS or arteriosclerosis risk. The present invention provides a C1q-adiponectin complex comprising naturally occurring adiponectin and C1q.

Abstract: The present invention relates to methods and compositions for monitoring, diagnosis, prognosis, and determination of treatment regimens in subjects suffering from or suspected of having a renal injury. In particular, the invention relates to using a one or more assays configured to detect Chitinase-3-like protein 1 as a predictive biomarker in renal injuries.

Abstract: The present invention relates to the field of biomarkers. More specifically, the present invention relates to biomarkers useful in diagnosing brain injuries. Brain injury can include overt or traumatic brain injury, as well as subclinical brain injury (SCI). In one embodiment, a method for diagnosing SCI in a patient comprises (a) collecting a sample from the patient, (b) measuring the levels of a panel of biomarkers in the sample collected from the patient, wherein the panel of biomarkers comprises ASTN1, BAI3, CNDP1, ERMIN, GFAP, GRM3, KLH32, MAGE2, NRG3, NRGN, OMG, SLC39A12, RTN1, and MT3; and (c) comparing the levels of the panel of biomarkers with predefined levels of the same panel of biomarkers than correlate to a patient having SCI and predefined levels of the same panel of biomarkers that correlate to a patient not having SCI, wherein a correlation to one of the predefined levels provides the diagnosis.

Abstract: A separation-free assay including a binding partner, a binding partner labeled with a directly luminescent label, and a nonspecifically binding label able to affect the signal of the unbound labeled binding partner, in which a signal of the binding partner label or the signal of the nonspecific binding label is measured in a binding event, and where at least one of the binding partners is a mobile binding partner.

Abstract: An anti-antibody reagent for use in a competitive or sandwich simplex or multiplex assay, said reagent comprising one or more labeled anti-antibodies for the primary antibodies to be determined in the assay, the reagent further comprising a corresponding unlabeled anti-antibody in an excess or near excess concentration with respect to their binding partners.

Abstract: Methods and products for the detection of oncofetal fibronectin indicating molecules in samples are provided. Methods for imaging of oncofetal fibronectin are provided. In some methods provided herein, the sample is treated with a reagent and/or contacted with a non-specific binder. Provided are methods for testing subjects to ascertain health and disease status and to assess the risk of developing a disease or condition. Methods for detecting the presence of oncofetal fibronectin indicating molecules by a variety of methods such as immunoassays and mass spectrometry also are provided.

Abstract: The present invention stems from the finding that the extracellular domain of CD31 proteins present on blood leukocytes is shed and released in the circulation as a soluble form of CD31. A method for detecting shed CD31 is further disclosed. The invention therefore relates to a method for detecting a shed ectodomain of a transmembrane protein such as CD31 and to the use of such a method as a diagnostic tool. The invention further provides methods for determining whether a candidate protein is part of a molecular complex.

Abstract: The present invention is directed to pharmaceutical agents and compositions useful for the treatment and prevention of amyloid disease in a subject. The invention further relates to isolated antibodies that recognize a common conformational epitope of amyloidogenic proteins or peptides that are useful for the diagnosis, treatment, and prevention of amyloid disease.

Abstract: The invention relates to standards for quantifying pathogenic aggregates or oligomers of endogenous proteins which characterize a protein aggregation disease, amyloid degeneration or protein misfolding diseases and use of these standards for quantifying these pathogenic aggregates or oligomers.

Abstract: The present invention pertains to the field of diagnostics for hematopoietic toxicity and toxicological assessments for risk stratification of chemical compounds. Specifically, it relates to a method for diagnosing hematopoietic toxicity. It also relates to a method for determining whether a compound is capable of inducing such hematopoietic toxicity in a subject and to a method of identifying a drug for treating hematopoietic toxicity. Furthermore, the present invention relates to a device and a kit for diagnosing hematopoietic toxicity.

Abstract: The invention relates to the identification of a biomarker whose abundance in biological sample is changed in subjects with osteoarthritis and/or other ageing-related diseases. The biomarker has applications in the diagnosis of osteoarthritis and/or other ageing-related diseases, in determining the prognosis for an individual diagnosed with osteoarthritis and/or other ageing-related diseases, and in monitoring the efficacy of treatment for osteoarthritis and/or other ageing-related diseases.

Abstract: A urinary biomarker for urinary tract cancers and applications of the same are revealed. TACSTD2 is used as a non-invasive urinary biomarker for urinary tract cancers due to a feature that the TACSTD2 protein is increased significantly in urine of patients with urinary tract cancers. The quantitative urinary biomarker shows high specificity and high sensitivity for urinary tract cancer detection. Besides increasing screening efficiency, early diagnosis and early treatment of urinary tract cancers, the biomarker can also be used to assess malignancy of urinary tract cancers and monitor tumor progression for determining optimal treatment against the disease and improving the treatment results.

Abstract: The present invention provides a means and a method for specifically measuring a substance such as a small substance with high sensitivity by a sandwich method. Specifically, the present invention provides an antibody capable of specifically binding to an affinity complex and a method of measuring of the affinity complex comprising measuring the affinity complex using the antibody capable of specifically binding to the affinity complex. The antibody of the present invention may be a full-length antibody. The antibody of the present invention may also have a region derived from an immunoglobulin from an animal having an ability of gene conversion (e.g., a complementarity-determining region, a framework region, or a variable region). Examples of at least one factor that constitutes the affinity complex include a small substance or a protein (e.g., antibody).