Abstract: The invention provides a method for detection of allergic inflammation in a subject that comprises assaying a test sample of peripheral blood from the subject for a marker of DNA damage. An elevated amount of marker present in the test sample compared to control sample is indicative of inflammation. The method can be adapted for quantitatively monitoring the efficacy of treatment of allergic inflammation in a subject. Markers of DNA damage include single- and/or double-stranded breaks in leukocytes, oxidative DNA damage in leukocytes, or a marker of nitric oxide oxidative activity (protein nitrosylation in leukocytes). This unexpected discovery of markers of systemic genotoxicity present in circulating leukocytes enables detection of allergic inflammation with a relatively simple and minimally invasive assay using peripheral blood.

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: 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).

Abstract: Methods and compositions are provided for assessing (e.g., diagnosing), treating, and preventing diseases, especially cancer, and particular lung cancer, using lung cancer markers (LCM). Individual LCM and panels comprising multiple LCM are provided for these and other uses. Methods and compositions are also provided for determining or predicting the effectiveness of a treatment or for selecting a treatment using LCM. Methods and compositions are further provided for modulating cell function using LCM. Also provided are compositions that modulate LCM (e.g., antagonists or agonists), such as antibodies, proteins, small molecule compounds, and nucleic acid agents (e.g., RNAi and antisense agents), as well as pharmaceutical compositions thereof. Further provided are methods of screening for agents that modulate LCM, and agents identified by these screening methods.

Abstract: Compositions and methods for inhibiting cancer cell metastasis and inflammation are disclosed. The methods generally involve administering to a subject a composition containing an agent that selectively inhibits the binding of p68 RNA helicase to calmodulin (CaM) in the cells.

Abstract: An Ang2 specific antibody, a method of inhibiting angiogenesis or a method of treating a disease related to the activation and/or overproduction of Ang2 using the antibody, and a composition for diagnosing a disease related to the activation and/or overproduction of Ang2 including the antibody.

Abstract: The invention relates to the use of ITIH5 as a biomarker of endometrium receptivity to embryo implantation. Also provided are methods and kits for using this biomarker for detecting the receptivity state of the endometrium of a mammal to embryo implantation, for diagnosing infertility in a female mammal, for the early diagnosis of pregnancy, for detecting the window of embryo implantation in the endometrium of a female mammal, for in vitrofertilization of a female mammal, and for diagnosing endometriosis.

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 Serum albumin, Protein S100-B, Glial cell line-derived neurotrophic factor, Resistin, Serum amyloid A protein, Hydrocortisone, Parathyroid hormone, and Tissue Plasminogen Activator as diagnostic and prognostic biomarkers in renal injuries.

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 polypeptides that bind to immunoglobulin G and methods for their use.

Abstract: Methods for producing an isotope-labeled mammalian, including a human, biomolecule, such as polypeptides and proteins, in a cell-free protein synthesis system. A biomolecule standard is produced having at least one isotope different in abundance than that of the naturally occurring isotopes in the biomolecule. Methods for quantifying biomolecules standards expressed using mammalian cell-free extracts are disclosed. Methods for producing such standards, kits, systems and reagents, relating to the use of isotope-labeled biomolecule as quantification standards in mass spectrometric and nuclear magnetic resonance analysis.

Abstract: The invention provides an apparatus and methodology to carry out biochemical testing on a centrifugal platform using flow splitting technique. In conventional biochemical testing, reagents need to be loaded individually into each reservoir. By using the flow splitting technique in this invention, one reagent only need to be loaded once, then, it can be evenly distributed into each reaction chambers in single or multiple layers format. The invention greatly reduces the required manpower when large numbers of assays are integrated on one platform. Because of the invention, many medical examinations can be performed efficiently, thus reduce the waste of manpower, time and cost.

Abstract: Management of the health status of an animal colony using a plurality of blood collection cards and the analysis of dried blood from members of the colony that has been collected on the cards. Members of the colony may be removed from the colony as a result of the analysis.

Abstract: The present invention relates to compositions and highly sensitive methods for the detection of biotechnology product residual when monitoring product carry over and/or for cleaning verification in the manufacture of biotechnology products. In particular, the present invention is directed to immunoassays wherein one or more capture antibodies, or antigen binding fragments thereof, are used to detect residuals associated with the production of biotechnology products.

Abstract: A method for determining the binding constant of interacting molecular species comprises the use of flat surfaces comprising perfluorinated polymers and measurements of reflected light intensity. The surfaces comprise at least one molecule with the receptor function absorbed or immobilized on the surface and at least one ligand that interacts with the receptor.

Abstract: The subject invention identifies CC chemokine ligand 20 (CCL20) as a novel biomarker for diagnosis of traumatic brain injury and/or neurodegeneration in the brain. The subject invention also provides treatment methods for traumatic brain injury and/or neurodegeneration in the brain by modulating systemic and/or brain-specific CCL20-CCR6 signaling. Also provided are uses of CCL20-CCR6 signaling a target for screening for therapeutic agents that are useful for treatment of traumatic brain injury.

Abstract: The present invention provides for a home test or a point of care test device that can both detect blood glucose and insulin levels and methods using said device. The device and methods can be used to aid diabetic patients and medical practitioners to fine tune insulin administration, and to monitor disease progression or treatment.

Abstract: Disclosed herein is a method for diagnosing Alzheimer's disease capable of minimizing invasiveness to reduce the risk of infection. The method for diagnosing Alzheimer's disease includes the steps of: pretreating an intranasal specimen; detecting tau protein or amyloid beta peptide (A?) in the pretreated intranasal specimen; comparing a value of the tau protein or the A? obtained in the detection step with a predetermined value; and displaying a comparison result obtained in the comparison step.

Abstract: The invention demonstrates an improved choice of biotinylation peptide to be used in a combination or fusion with an MHC molecule for immobilizing or multimerising such MHC molecules for a variety of purposes.

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: Biomarkers useful for identifying treatments for and monitoring treatment of patients with multiple sclerosis (MS) are provided, as well as methods for their identification, methods of diagnosing MS, relapse of MS patients and disease progression in MS patients.

Abstract: The invention provides active and passive immunization methods for preventing and treating Clostridium difficile infection, which involve percutaneous administration of C. difficile toxin-neutralizing polyclonal immune globulin, C. difficile toxoids, or combinations thereof. Also provided by the invention are C. difficile toxoids, C. difficile toxin-neutralizing polyclonal immune globulin, and methods of identifying subjects that produce C. difficile toxin-neutralizing polyclonal immune globulin.

Abstract: An anti-Ang2 antibody or an antigen-binding fragment thereof that specifically binds to an angiogenesis-inducing factor Angiopoietin-2 (Ang2) and complexes with a Tie2 receptor and Ang2, and related methods and compositions.

Abstract: The present invention relates to the field of biomarkers. More specifically, the present invention relates to biomarkers useful in diagnosing brain injury or neurodegeneration. In one embodiment, a method for diagnosing brain injury in a patient comprises the steps of (a) obtaining a sample from the patient; (b) determining the ratio of citrullinated to unmodified arginine residues at one or more arginine residues of one or more brain injury biomarker proteins; and (c) correlating the ratio to a patient having brain injury or to a patient not having brain injury, thereby providing the diagnosis.

Abstract: [Problem] The present invention aims to elucidate a polynucleotide as a novel responsible gene for cancer and aims to thus provide a method for detecting the polynucleotide and a polypeptide encoded by the polynucleotide and a detection kit, a probe set, and a primer set for the detection. The present invention also aims to provide a pharmaceutical composition for treating cancer. [Means for Solution] The method detects a fusion gene composed of a portion of an FGFR3 gene and a portion of a TACC3 gene or a fusion protein encoded by the fusion gene. The primer set, the probe set, or the detection kit comprises a sense primer and a probe set designed from the portion encoding FGFR3 and an antisense primer and a probe set designed from the portion encoding TACC3. Since an inhibitor of the polypeptide exhibits antitumor effect, a pharmaceutical composition for treating cancer which is positive for either the fusion gene or the polypeptide is provided.

Abstract: Compositions and methods for producing monoclonal antibodies and their derivatives reactive against bioactive lipid targets are described. These compositions include derivatized lipids, each of which comprises a bioactive lipid that having a polar head group and at least one hydrocarbon chain (e.g., a lysolipid such as lysophosphatidic acid or sphingosine-1-phosphate) in which a carbon atom has been derivatized with a pendant reactive group; immunogens made by linking a derivatized lipid to a carrier moiety (e.g., a carrier protein, polyethylene glycol, colloidal gold, alginate, or a silicone bead); monoclonal antibodies and derivatives produced by immunizing an animal with such an immunogen; and therapeutic and diagnostic compositions containing such antibodies and antibody derivatives.

Abstract: A novel monoclonal antibody and like antigen-binding molecules against transmembrane protein with EGF-like and two follistatin-like domains 2 (TMEFE2) are provided with unique immunological and biological properties useful in the therapy of affective disorders such as depression and bipolar disorders as well as anxiety disorders. In addition, pharmaceutical compositions and kits comprising such antibody and derivatives thereof are described.

Abstract: Provided is a means for improving measurement accuracy in an immunoassay using a dry plastic cell. A method for reducing adsorption of bubbles onto a cell side surface in an immunoassay, the method including carrying out a reaction and/or measurement in a presence of a surfactant, wherein the immunoassay comprises carrying out an antigen-antibody reaction in a dry plastic cell using an immunoassay reagent which immunologically reacts with a substance to be measured in a sample and carrying out an optical measurement of a resultant reacted product.

Abstract: The present invention relates to a myostatin inhibitor comprising extracellular water-soluble domains of delta-like 1 homolog (DLK1) as active ingredients. More particularly, the present invention relates to a composition for inhibiting myostatin activity, comprising, as active ingredients, extracellular water-soluble domains of DLK1 or a deletion mutant of extracellular water-soluble domains of DLK1. The myostatin inhibitor of the present invention is bonded to the myostatin or activin receptor type IIB so as to inhibit the action mechanism of the myostatin, to thereby promote myogenesis and prevent differentiation into fat cells. Therefore, the myostatin inhibitor of the present invention may be used in preventing and treating diseases such as muscular dysplasia that requires differentiation to muscular cells, or metabolic diseases.

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 are human alpha-synuclein-specific autoantibodies as well as fragments, derivatives and variants thereof as well as methods related thereto. Assays, kits, and solid supports related to antibodies specific for ?-synuclein are also disclosed. The antibody, immunoglobulin chain(s), as well as binding fragments, derivatives and variants thereof can be used in pharmaceutical and diagnostic compositions for ?-synuclein targeted immunotherapy and diagnosis, respectively.

Abstract: Biomarkers such as exosomes and/or RNA, e.g., microRNA, can be used for diagnostic, therapy-related or prognostic methods to identify phenotypes, such as a condition or disease, for example, the stage or progression of a disease. Such biomarkers can be used in profiling of physiological states or determining phenotypes. Biomarkers can be used to determine treatment regimens for diseases, conditions, disease stages, and stages of a condition, and can also be used to determine treatment efficacy. Biomarkers can also be used to identify conditions of diseases of unknown origin.

Abstract: Methodologies and technologies for potentiating antibody-based cancer treatments by increasing complement-mediated cell cytotoxicity are disclosed. Further provided are methodologies and technologies for overcoming ineffective treatments correlated with and/or caused by sub-lytic levels of complement-activating monoclonal antibodies (“mAb”) against cancer antigens or cancer antigens with low tumor cell density. While detectable levels of passively administered or vaccine-induced mAb against some antigens are able to delay or prevent tumor growth, low levels of mAb induce sublytic levels of complement activation and accelerate tumor growth. This complement-mediated accelerated tumor growth initiated by low mAb levels results in activation of the PI3K/AKT survival pathway. Methodologies and technologies relating to administration of PI3K inhibitors to overcome low dose mAb-initiated, complement-mediated PI3K activation and accelerated tumor growth are disclosed.

Abstract: The invention provides compositions (e.g., peptide compositions) useful for the detection of antibodies that bind to Ehrlichia antigens. The peptide compositions comprise polypeptide sequences based on an immunogenic fragment of the Ehrlichia Outer Membrane Protein 1 (OMP-1) protein. The invention also provides devices, methods, and kits comprising such peptide compositions and useful for the detection of antibodies that bind to Ehrlichia antigens and the diagnosis of monocytic ehrlichiosis.

Abstract: A magnetizable trap and flow system and process are detailed that uniformly disperse paramagnetic or superparamagnetic analyte capture beads within a scaffold of magnetizable beads or other magnetizable materials in a capture zone that provides selective capture of target analytes. A magnet placed or energized in proximity to the trap may magnetize the magnetizable scaffold and secure the paramagnetic or superparamagnetic analyte capture beads in their uniformly dispersed state within the magnetizable scaffold to provide selective capture of target analytes.

Abstract: The invention refers to a method for diagnosing an individual who is to be subjected to or is being subjected to an anti-tumour necrosis factor alpha (TNF? or TNF) treatment to asses the responsiveness to an anti-TNF treatment which comprises the detection of immunoglobulin(s) against one or more biomarker proteins in a bodily fluid or an excrement of said patient, and sorting the individual into one of two categories based on detection of said immunoglobulin(s), wherein individuals are classified as NON-responder or responder. The invention refers to diagnostic kits comprising said one or more biomarker proteins and the use of these kits for assessing the responsiveness to an anti-TNF treatment of an individual who is to be subjected to or is being subjected to an anti-TNF? treatment.

Abstract: Provided herein are methods, assays and kits for evaluating a sample, e.g., a sample obtained from a cancer patient, to detect one or more hedgehog biomarkers and/or one or more cilium markers. Thus, the invention can be used, inter alia, as a means to identify patients likely to benefit from administration of one or more hedgehog inhibitors, alone or in combination with therapeutic agents; to predict a time course of disease or a probability of a significant event in the disease of a cancer patient; to stratify patient populations; and/or to more effectively treat or prevent a cancer or a tumor associated with hedgehog signaling.

Abstract: The present invention provides a method for the assay of synucleins in a body fluid or tissue sample, wherein said method comprises the steps of contacting said sample with membrane lipids under conditions enabling binding of the synuclein to said lipids, and the detection of the lipid-bound synuclein by a synuclein-binding agent.

Abstract: This document relates to methods and materials involved in identifying, assessing, and monitoring prostate cancer in male mammals. For example, this document provides arrays for detecting polypeptides or nucleic acids that can be used to identify prostate cancer in male mammals. In addition, methods and materials for assessing and monitoring prostate cancer in mammals are provided herein.

Abstract: The invention provides a method of estimating free light chain production (FLC) in a subject comprising (i) determining an amount of FLC in a sample from the subject; and (ii) correcting the amount of FLC in the sample for FLC cleared from the source of the sample by glomerular filtration and by reticuloendothelial (RE) clearance.

Abstract: Methods for treatment and diagnosis of pervasive developmental disorders in humans are described.

Abstract: The present invention relates to monoclonal antibodies and antigen-binding portions thereof that specifically bind to the C-terminal or the center region of macrophage migration inhibitory factor (MIF). These anti-MIF antibodies and antigen-binding portions thereof further inhibit human MIF biological function. The invention also relates to isolated heavy and light chain immunoglobulins derived from anti-MIF antibodies and nucleic acid molecules encoding such immunoglobulins. The present invention also relates to a method of identifying anti-MIF antibodies, pharmaceutical compositions comprising these antibodies and a method of using these antibodies and compositions for the treatment of MIF-related conditions.

Abstract: The present invention generally relates to compositions, reagents and methods for detecting and treating a neural tube defect in a fetus. One aspect of the invention provides a method including administrating a composition containing noggin or LDN-193189 to the fetus in utero. In certain embodiments, the composition is administrated if the maternal blood or amniotic fluid contains an elevated amount of BMP4 and/or a reduced amount of noggin. In another aspect of the invention, the method includes administrating a composition containing GDC-0449 to the fetus in utero. In certain embodiments, the GDC-0449 is administrated if the maternal blood or amniotic fluid contains an elevated amount of sonic hedgehog.

Abstract: The invention relates to a method for the diagnosis or prediagnosis of a ?-amyloidopathy or an ?-synucleopathy accompanied by a cerebral protein deposit and a reduced activity of the cerebral ABCC1-transporter, or for determining the risk of a proband suffering from such an illness, the proband already having accumulated substances transported by the cerebral ABCC1 transporter.

Abstract: The present invention provides a pharmaceutical composition for preventing or treating angiogenic diseases comprising inhibitors of NUP153 gene expression or NUP153 activity as active ingredient and a method for screening an agent for preventing or treating angiogenic diseases. According to the present invention, inhibition of the NUP153 gene expression or the NUP153 activity reduces export of mRNA of a pro-angiogenic factor (VEGF, HGF and bFGF) from nucleus. In addition, inhibition of the NUP153 gene expression or the NUP153 activity has effect that angiogenesis are inhibited by inhibition of invasion and tube formation in a dose-dependent manner without showing toxicity. Therefore, the pharmaceutical composition of the present invention may be used for preventing or treating a variety of angiogenesis-related diseases, and the method for screening of the present invention may be valuably used in finding a new agent for preventing or treating angiogenic diseases.

Abstract: The present invention is directed to compositions of matter useful for the diagnosis and treatment of tumor in mammals and to methods of using those compositions of matter for the same.

Abstract: The present invention concerns the field of tumor therapeutics and diagnostics. Specifically, it relates to a peptide comprising at least 8 amino acids in length which are present as contiguous amino acid sequence in the human Isocitratdehydrogenase Type 1 (IDH1), wherein said peptide has at least one amino acid exchange from R to H at a position corresponding to position 132, for use in preventing and/or treating cancer. Further contemplated is a medicament comprising the said peptide.

Abstract: This invention provides methods and kits for the detection of tau-associated neurodegenerative diseases, such as Alzheimer's disease, prior to the onset of clinical symptoms. The method generally involves determining the amount of one or more tau protein isoforms in a biological sample relative to a suitable control, where an altered amount of the tau isoform(s) relative to the control identifies the presence of a tau-associated neurodegenerative disease. Such methods can also be applied more generally for the detection of tau abnormalities in any biological sample.

Abstract: The present invention relates to disorder-specific epitopes recognized by myeloperoxidase-anti-neutrophil cytoplasmic autoantibodies and the use of polypeptides comprising the epitopes in methods of diagnosing and monitoring autoimmune disorders associated with the autoantibodies.

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