Abstract: Method for the determination of the renal function wherein the amount of at least one agrin fragment derived by neurotrypsin cleavage of agrin is measured in a sample taken from a patient and the measured amount of the agrin-fragment in the sample is used as indicator for renal function.

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

Abstract: The present disclosure provides methods of developing a specific immunoassay for the Pharmacokinetic assessments of peptides, peptide oligomer and polymer including Glatiramer Acetate (GA), also known as Copolymer 1, Copolymer-1, Cop 1 or Cop in the clinical and preclinical matrices.

Abstract: Provided herein are sensors, kits that include such sensors, and methods for making and using such sensors. The sensors permit detection of a broad array of target molecules, such as nucleic acids (e.g., DNA and RNA), proteins, toxins, pathogens, cells, and metals, and can be used in combination with pH meters and pH paper. Thus, this disclosure provides a new methodology that allows pH meters and pH paper to be used for the detection of analytes other than pH.

Abstract: The present invention relates to an in vitro use of a number of IL-4 and/or IL-13 secreting T-cells as a biomarker for diagnosing and/or monitoring an IgE-dependent allergic disease.

Abstract: The present disclosure is directed to methods and kits for detecting, characterizing, preventing, and treating cancer, e.g., pancreatic cancer, or inflammation, by determining the presence of circulating epithelial in a biological sample and further identifying the tissue of origin using a tissue-specific biomarker, e.g., Pdx-1.

Abstract: The present invention relates to methods of diagnosing, prognosing or treating diseases or disorders in which elevated or reduced levels of A? protein, including A?1-42 are prevalent. In particular, the present invention relates to methods of diagnosing, prognosing or treating a major or minor depressive episode/disorder attributed to elevated or reduced levels of A? protein, including A?1-42, found particularly in body fluids including whole blood, blood cells, serum, plasma, urine and CSF as well as in the brain. The invention also relates to the treatment of these disorders by administering an agent that either prevents production of A?, prevents aggregation of A? fibrils, or that increases the degradation or clearance of A?. In addition, the invention provides a method of treating or preventing a major or minor depressive disorder by administering an agent that prevents or interferes with A?-induced neurotoxicity.

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

Abstract: Provided are methods for screening a subject for cancer. The methods involve obtaining a blood sample from the subject and determining a level of Bridging Integrator 1 (BIND isoforms comprising exon 12a in the sample. Optionally, the method involves determining a level of 12a+/13? BIN isoform (comprising exon 12a but lacking exon 13) in the sample. An elevated level of 12a+ (e.g., 12a+/13?) BIN1 isoforms in the blood sample indicates the subject has cancer. Also provided are methods for determining efficacy of a cancer therapy in a subject and methods of treating cancer. Isolated antibodies that selectively bind human 12a+ BIN1 are also provided as well as kits for determining 12a+/13? BIN1 isoforms.

Abstract: Reagents, kits and methods for detecting biological molecules by energy transfer from an activated chemiluminescent substrate to an energy acceptor dye such as a J-aggregated dye are described.

Abstract: The present invention relates to methods of diagnosing, prognosing or treating diseases or disorders in which elevated levels of Abeta protein, including abeta1-42 are prevalent. In particular, the present invention relates to methods of diagnosing, prognosing or treating a major or minor depressive episode/disorder attributed to elevated levels of Abeta protein, including abeta1-42, found particularly in body fluids including whole blood, blood cells, serum, plasma, urine and CSF. The invention also relates to the treatment of these disorders by administering an agent that either prevents production of Abeta, prevents aggregation of Abeta fibrils, or that increases the degradation or clearance of Abeta. In addition, the invention provides a method of treating or preventing a major or minor depressive disorder comprising administering an agent that prevents or interferes with Abeta-induced neurotoxicity.

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 SPARC, Follistatin-related protein 1, Tumor necrosis factor receptor superfamily member 21, Growth arrest-specific protein 1, MHC class I polypeptide-related sequence A, Syndecan-1, and WNT1-inducible-signaling pathway protein 1 as diagnostic and prognostic biomarkers in renal injuries.

Abstract: The present invention provides biological markers associated with gastric cancer. In particular, the present invention provides a method of diagnosing gastric cancer (GC) in a subject, the method including: measuring an expression level of one or more proteins in the subject, wherein the one or more proteins are selected from the group consisting of vitamin D binding protein (VDBP), clusterin, insulin like growth factor binding protein complex acid labile subunit (IGFALS), and afamin; comparing the expression level of the or each protein in the subject to a reference expression level for the or each protein; and diagnosing GC in the subject on the basis of the comparison.

Abstract: The present invention relates to a method for the detection of a substance in an aqueous, physiological or chemical liquid using the evanescence field method, and to a diagnostic device for carrying out said method.

Abstract: Disclosed is an assay (method) to quantify the amounts of catecholamine-O-methyltransferase (COMT) protein in samples, such as extracts from cell cultures, body fluids, tissues, and environmental samples. It uses novel agents (anti-NE, COMT-NE, or COMT-epitope-NE) in combination with two previously described agents (anti-COMT and COMT) in a competitive ELISA system to achieve this aim.

Abstract: The invention relates to a method of diagnosing or monitoring schizophrenia or other psychotic disorder.

Abstract: The present invention relates to methods and compositions for monitoring, diagnosis, prognosis, and determination of treatment regimens in sepsis patients. In particular, the invention relates to using assays that detect one or more biomarkers selected from the group consisting of Insulin-like growth factor-binding protein 7, Beta-2-glycoprotein 1, Metalloproteinase inhibitor 2, Alpha-1 Antitrypsin, Leukocyte elastase, Serum Amyloid P Component, C-X-C motif chemokine 6, Immunoglobulin A, Immunoglobulin G subclass I, C-C motif chemokine 24, Neutrophil collagenase, Cathepsin D, C-X-C motif chemokine 13, Involucrin, Interleukin-6 receptor subunit beta, Hepatocyte Growth Factor, CXCL-1, -2, -3, Immunoglobulin G subclass II, Metalloproteinase inhibitor 4, C-C motif chemokine 18, Matrilysin, C-X-C motif chemokine 11, and Antileukoproteinase as diagnostic and prognostic biomarker assays of renal injury in the sepsis patient.

Abstract: Methods for detecting colorectal cancer in a subject by detection of a galactose-containing 40 kDa molecule in a serum sample from the subject. Methods for quantifying the amount of a galactose-containing molecule in a serum sample are also provided.

Abstract: The present invention addresses the simultaneous detection and quantitative measurement of multiple biomolecules, e.g., pathogen biomarkers through either a sandwich assay approach or a lipid insertion approach. The invention can further employ a multichannel, structure with multi-sensor elements per channel.

Abstract: A method of detecting active TB in a patient comprising providing at least one peptide comprising an amino acid sequence with at least 80% sequence identity to a sequence selected from SEQ. ID NOS. 1 to 8, or an antigenic fragment thereof and contacting the peptide with a biological sample obtained from the patient. The presence of an antibody in the sample binding to the peptide is indicative of active TB in the patient.

Abstract: Methods and compositions are provided for detecting molecular translocations, particularly protein translocations within and between sub-cellular compartments, using at least two components that exhibit a localization-dependent difference in complementation activity. In particular, alpha-complementing ?-galactosidase fragments are provided. These ?-galactosidase reporter fragments display significantly enhanced enzymatic activity when one fragment is localized in a membrane. Methods for carrying out no-wash ELISA assays based on the reporter component system are also provided.

Abstract: The present invention provides monoclonal antibodies which specifically recognize the shorter A? peptides obtained after cleavage of the APP protein mediated by ?-secretase, i.e. the A?-peptide fragments A?1-37, A?3-37, A?3p-37, A?1-37 and A?11p-37, and other like fragments ending at the 37th amino acid of APP, hereinafter also referred to as the A?x-37 peptides. It further provides hybridoma cells producing the monoclonal antibodies as well as methods for producing the antibodies and the hybridoma cells; and an immunoassay for an A?x-37 peptide by a competitive method or a sandwich method using the antibody of the present invention; and methods for measuring the level of A?x-37 peptides in a sample, such as a biological sample.

Abstract: The invention relates to methods and products associated with in vivo enzyme profiling. In particular, biomarker nanoparticles capable of quantitatively detecting enzymatic activity in vivo are described. These nanoparticles can be used to detect in vivo enzyme activity. The invention also relates to products, kits, and databases for use in the methods of the invention.

Abstract: Antibodies and fragments thereof have high affinity for human ?-synuclein protofibrils and low binding of ?-synuclein monomers, wherein the antibodies or fragments have specified Complementarity Determining Region (CDR) sequences. Compositions comprise such an antibody or fragment and methods of detecting ?-synuclein protofibrils use such an antibody or fragment. In further embodiments, methods of preventing, delaying onset of or treating a neurodegenerative disorder with ?-synuclein pathology comprise administering such an antibody or fragment, and such an antibody or fragment is used in the manufacture of a pharmaceutical composition for treatment of a neurodegenerative disorder with ?-synuclein pathology. Such an antibody or fragment is used in the diagnosis or monitoring of the development of a neurodegenerative disorder with ?-synuclein pathology, and in methods for reducing or inhibiting ?-synuclein aggregation by administration of such an antibody or fragment.

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 Growth/differentiation factor 2, Catalase, Vascular endothelial growth factor C, and Melanoma-derived growth regulatory protein as diagnostic and prognostic biomarkers in renal injuries.

Abstract: Low levels of antibodies reactive with oxidised Cardiolipin (oxCL) in mammals are related to an increased risk of developing cardiovascular diseases, auto-immune diseases or inflammatory conditions. High levels can have a protective function and in general there is a negative association between manifestations of these conditions and antibodies against oxCL. Thus, based on their relations methods of monitoring, determining and diagnosing as well as methods of immunisation and therapy of these diseases and conditions are provided.

Abstract: The subject invention pertains to materials and methods for diagnosing and/or predicting pathologic infant conditions. A method of the invention comprises obtaining a biological sample from an infant and analyzing the sample to detect at least one protein biomarker of necrotizing enterocolitis (NEC), wherein a patient is diagnosed with NEC or determined to have a likelihood of developing NEC following detection of the biomarker. In another method of the invention, the likelihood of a patient developing NEC is determined. In certain embodiments, treatment is administered to the patient following diagnosis of NEC or determination that the patient has a likelihood of developing NEC.

Abstract: Assays for detecting anti-streptococcal antibodies in biological samples using one or more streptococcal antigens are described herein. Various combinations of antigens may be used in the assays. For example, one or more of Ply, PhtD, PhtE, LytB and PcpA may be utilized. Additional streptococcal antigens may also be used. The assays may also be used in combination with assays that detect streptococcal nucleic acids.

Abstract: Methods and compositions are disclosed for predicting and treating the clinical benefit to a human renal cell carcinoma patient prior to their treatment with a VEGFR inhibitor and an Ang2 inhibitor.

Abstract: The present invention describes methods for determining the risk that a breast precursor lesion will progress to invasive breast cancer and/or the risk of recurrent non-invasive disease in a patient, comprising detecting the presence and/or level of PAPPA and/or PAPPA functional activity in a breast tissue sample obtained from the patient, wherein if PAPPA is not present, or is present at a reduced amount compared to a control, there is the risk of progression to invasive cancer and/or the risk or recurrent disease. The present invention also enables the chemosensitisation of mitotically delayed breast cancer cells to anti-proliferative agents, preferably anti-mitotic agents, by restoring normal progression through mitosis. In this embodiment a first drug is applied to release breast cancer cells from the mitotic block and, sequentially, a second drug affecting proliferating cells is administered for cancer cell killing.

Abstract: The invention provides an antibody binding specifically to Cynomolgus IgG characterized by not binding to Human IgG, and a method for the immunological determination of an immune complex (DA/ADA complex) of a drug antibody (DA) and an antibody against said drug antibody (anti-drug antibody, ADA) in a sample of a monkey species using a double antigen bridging immunoassay.

Abstract: The present invention relates to an exemplary in vitro diagnostic (IVD) device used to detect the presence of and/or severity of neural injuries or neuronal disorders in a subject. The IVD device relies on an immunoassay which identifies biomarkers that are diagnostic of neural injury and/or neuronal disorders in a biological sample, such as whole blood, plasma, serum, cerebrospinal fluid (CSF). The inventive IVD device may measure one or more of several neural specific markers in a biological sample and output the results to a machine readable format wither to a display device or to a storage device internal or external to the IVD.

Abstract: The present invention concerns a microfluidic system comprising: a microchannel containing several elements of two non-miscible fluids, the microchannel comprising a droplet (30) containing magnetic particles (M), and a device for generating inside the microchannel magnetic field, said device comprising an activable magnetic element, the activable magnetic element comprising a tip (5,6), the microfluidic system being configured to transport the droplet by flow or by pressure difference.

Abstract: Herein is reported a method for the detection of free antigen of a multispecific antibody in a sample, whereby the antigen to be detected can be specifically bound by a first binding site of the multispecific antibody, comprising the step of incubating a sample comprising free antigen and multispecific antibody with an anti-idiotypic antibody, which specifically binds to a second binding specificity of the bispecific antibody, which is different from the first binding specificity, whereby the anti-idiotypic antibody is bound to a solid phase.

Abstract: The present invention relates to the field of immunology and hyperproliferative diseases. More specifically, the present invention relates to a method of detecting and monitoring therapeutic antibody:antigen complex, soluble antigen and soluble therapeutic antibody, wherein a patient has undergone at least one course of immunotherapy. Yet further, levels of therapeutic antibody:antigen complexes, soluble antigens or soluble therapeutic antibodies may be measured and used to stage or monitor a hyperproliferative disease.

Abstract: Provided are monoclonal antibodies, or antigen-binding fragments thereof, that bind to glucagon. These antibodies are useful in immunoassays of glucagon levels, and/or in vivo, ex vivo or in vitro immunochemical and other imaging methods for detecting glucagon levels, and for diagnostic, prognostic and predictive purposes, and for optimizing therapeutic regimens in patients in which glucagon signaling is implicated in pathogenesis.

Abstract: Systems and methods are provided for collecting, preparing, and/or analyzing a biological sample. A sample collection site may be utilized with one or more sample processing device. The sample processing device may be configured to accept a sample from a subject. The sample processing device may perform one or more sample preparation step and/or chemical reaction involving the sample. Data related to the sample may be sent from the device to a laboratory. The laboratory may be a certified laboratory that may generate a report that is transmitted to a health care professional. The health care professional may rely on the report for diagnosing, treating, and/or preventing a disease in the subject.

Abstract: The invention relates to an epitope protection assay for use in diagnosis, prognosis and therapeutic intervention in diseases, for example, involving polypeptide aggregation, such as prion infections. The methods of the invention first block accessible polypeptide target epitope with a blocking agent. After denaturation of the polypeptide, a detecting agent is used to detect protein with target epitope that was inaccessible during contact with the blocking agent. The invention also relates to novel amyotrophic lateral sclerosis-specific epitopes and their uses to make antibodies, and to the novel antibodies and uses thereof.

Abstract: Provided herein are compositions and methods for examining the progression, regression or risk of individuals at risk for developing coronary artery disease (CAD).

Abstract: The invention relates to an immunogenic peptide of eight amino acids that is generated naturally in the intestine of celiac patients by means of the hydrolysis of ingested gluten. In addition, the invention relates to the use of the peptide, or antibodies generated against same, for the in vitro monitoring and/or diagnosis of celiac disease, as well as to the use of such antibodies for the detection of gluten in food. The invention further relates to the use of the aforementioned peptide as a therapeutic target for the development of compounds or compositions for use in the diagnosis, treatment and/or prevention of this pathological condition, as well as to the use of the peptide and the antibodies against same for the prevention and/or treatment of celiac disease.

Abstract: Provided herein is an all-in-one saliva collection apparatus that collects saliva to allow for the filtration of saliva in order to separate saliva components, such as extracellular proteins and nucleic acids that are not present in intact cells, from the intact cells and debris remaining in the extracted sample. The filtered saliva samples can be aliquoted into two fractions for protein and/or nucleic acid analysis. The present invention further describes long term storage at ambient temperatures of filtered salivary nucleic acids, and long term storage at ambient temperatures of filtered salivary proteins added to an ethanol solution. The filtered cell-free saliva samples have diagnostic usefulness.

Abstract: A method for the risk detection, early diagnosis, prognosis, and monitoring of Parkinson's disease in an individual by measuring the amount of specific biomarkers present in a bodily fluid and comparing them to a reference level of biomarkers in a sample from a healthy person, a person previously diagnosed with Parkinson's disease, or an earlier sample from the individual of interest.

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.

Abstract: The present invention relates to the field of diagnostic methods. Specifically, the present invention contemplates a method for diagnosing pancreatic cancer in a subject, a method for identifying whether a subject is in need for a therapy of pancreatic cancer or a method for determining whether a pancreatic cancer therapy is successful. The invention also relates to tools for carrying out the aforementioned methods, such as diagnostic devices.

Abstract: The purpose of the present invention is to develop: a method for selectively separating a glycoprotein derived from the central nervous system from a body fluid or a central nervous system cell; and a method for searching for an index marker for central nervous system diseases, which utilizes the aforementioned method. A protein derived from the central nervous system, which occurs in a trace amount in a body fluid or a central nervous system cell, can be selectively enriched by a two-stage separation procedure comprising removing a glycoprotein having sialic acid at a non-reducing terminal thereof from the body fluid or the central nervous system cell and then separating a glycoprotein having N-acetylglucosamine at a non-reducing terminal thereof.

Abstract: The present invention provides an antibody that recognizes a polypeptide comprising the amino acid sequence represented by SEQ ID NO: 15 in the Sequence Listing and has an anti-arthritic function, or a functional fragment thereof.

Abstract: Antibodies directed to the antigen ANGPTL4 and uses of such antibodies. In accordance with the teachings herein, there are provided fully human monoclonal antibodies directed to the antigen ANGPTL4. Nucleotide sequences encoding, and amino acid sequences comprising, heavy and light chain immunoglobulin molecules, particularly sequences corresponding to contiguous heavy and light chain sequences spanning the framework regions and/or complementarity determining regions (CDR's), specifically from FR1 through FR4 or CDR1 through CDR3, are provided. Hybridomas or other cell lines expressing such immunoglobulin molecules and monoclonal antibodies are also provided.

Abstract: Methods and compositions are described for the diagnosis of primary biliary cirrhosis. Novel autoantigens are described for use in assays which employ test samples from individuals.

Abstract: Compositions are disclosed comprising an effective amount of nitrated fibrinogen and a pharmaceutically acceptable carrier for detecting a patient's risk for coronary artery disease. The compositions can be used to determine the presence of nitrated fibrinogen which is linked with coronary artery disease. Also disclosed is a method for determining the presence or risk for coronary artery disease or risk for increased propensity for an adverse thrombotic event in a patient.

Abstract: The present invention relates to compositions and methods for cancer diagnosis, research and therapy, including but not limited to, cancer markers. In particular, the present invention relates to polypeptides found in extracellular microvesicles as diagnostic and screening markers, and clinical targets for cancer (e.g., prostate cancer).