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 Dashurin as a diagnostic and prognostic biomarker in renal injuries.

Abstract: Disclosed is a method for treatment of HIV related diseases comprising targeting complexes between on the one hand the C5 domain of gp120 and on the other hand gp41 or the C2 domain of gp120. The complexes may be stabilised by administering compounds, such as antibodies, capable of directly interacting with and stabilising the complex, or by immunizing with C5 and gp41/C2 derived material so as to induce antibodies that bind to and stabilise the complex.

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 Beta-2-glycoprotein 1 as a diagnostic and prognostic biomarker in renal injuries.

Abstract: Engineered multivalent and multispecific binding proteins, methods of making, and their uses in the prevention, diagnosis, and/or treatment of disease are provided.

Abstract: The invention provides compositions and methods for prevention and treatment of diseases associated with ?-amyloid formation and/or aggregation. Such methods encompass the induction of an immune response against N-terminal truncated and/or post-translationally modified A? peptides. These peptides are further used in compositions and methods for the diagnosis of diseases associated with ?-amyloid formation and/or aggregation.

Abstract: An in vitro method of determining activation or inactivation of the atrial natriuretic peptide (ANP) and brain natriuretic peptide (BNP) hormonal systems, the method comprising simultaneously detecting the presence or amount of atrial and brain natriuretic peptide prohormones (proANP and proBNP) or fragments thereof in a sample.

Abstract: The present invention relates to the use of soluble CD163 as a prognostic marker for the assessment of the risk for contracting a disorder, in particular for contracting diabetes and/or a liver disorder. The invention also relates to the use of CD163 as a prognostic marker for assessing lifetime expectancy.

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

Abstract: Disclosed are methods for conducting assays of samples, such as whole blood, that may contain cells or other particulate matter. Also disclosed are systems, devices, equipment, kits and reagents for use in such methods. One advantage of certain disclosed methods and systems is the ability to rapidly measure the concentration of an analyte of interest in blood plasma from a whole blood sample without blood separation and hematocrit correction.

Abstract: The present invention provides Tumor Endothelial Marker 5? (TEM5?) polypeptides and nucleic acid molecules encoding the same. The invention also provides selective binding agents, vectors, host cells, and methods for producing TEM5? polypeptides. The invention further provides pharmaceutical compositions and methods for the diagnosis, treatment, amelioration, or prevention of diseases, disorders, and conditions associated with TEM5? polypeptides.

Abstract: There is a demand for improved turbidimetric immunoassays for human Cystatin C in biological samples, especially in human clinical samples of body fluids. The present invention provides a turbidimetric immunoassay method and reagent set enabling measurement of human Cystatin C by turbidimetric methods, resulting in a surprisingly stronger and faster turbidimetric signal than in the present state of the art. The increased and faster signal is accomplished by the use of new reagents and compositions, and enables shorter assay times and kinetic reading with a stronger signal, improving overall assay speed and quality. Improved robustness to lipid interference and improved linearity is achieved.

Abstract: Use of busulfan amide as stabilized standards in immunoassays for quantifying the amount of busulfan in samples of human biological fluids, methods for carrying out said immunoassay and kits for use in said immunoassay.

Abstract: A method for determining whether early stage cancer is present in a subject comprises detecting the expression level of GASP-1 in the subject by detecting the amount of GASP-1 peptide fragments present in a biological sample of the subject. Because cancer can be detected at an early stage, therapeutic targeting may be initiated before cancer reaches late stage (e.g., before the development of overt symptoms). A method for treating early stage cancer in a subject comprises administering to the subject an effective amount of a GASP-1 inhibitor to inhibit the progression of early stage cancer to late stage cancer. A Competitive ELISA capable of detecting GASP-1 peptide fragments at a concentration of less than 1 ng/ml was developed.

Abstract: The application discloses MCAM as a new biomarker for acute heart failure; methods for predicting, diagnosing, prognosticating and/or monitoring acute heart failure based on measuring said biomarker; and kits and devices for measuring said biomarker and/or performing said methods.

Abstract: The present disclosure provides methods of diagnosing chronic heart failure in patients by detecting the presence and amounts of biomarkers of heart failure in samples from the patients. Such biomarkers may be used to develop a more accurate prognosis for a patient with heart failure, or to accurately diagnose a patient suspected of having heart failure.

Abstract: Detection sequences of periostin having from 6 to 30 amino acids and which include all or part of peptide sequence SEQ ID No. 1, SEQ ID No. 2 or SEQ ID No. 3, or a homologous peptide sequence. Antibodies suitable for specifically recognizing minimally one of these detection sequences, including an anti-periostin antibody, are disclosed. Periostin detection and dosage processes and kits that use these antibodies are also disclosed. A periostin marker for early diagnosis, tracking and prognosis of pathologies that involve periostin, including benign osteolysis such as inflammatory diseases, including osteoarticular diseases, and malignant osteolysis, such as cancers with bone metastases, is provided.

Abstract: Novel conjugates of doxorubicin and novel doxorubicin immunogens derived from the 13 and 14 positions of doxorubicin and antibodies generated by these doxorubicin linked immunogens all of which are useful in immunoassays for the quantification and monitoring of doxorubicin in biological fluids.

Abstract: The disclosed invention relates to monoclonal antibodies (MAbs) which recognize human fatty acid synthase (hFAS) and are distinct from previously known anti-hFAS antibodies. Compositions, devices and kits comprising the MAbs are provided along with methods of using the MAbs in a variety of applications.

Abstract: The present invention relates to a method for identifying hypoallergenic polypeptides and to a corresponding screening method. The invention further relates to hypoallergenic polypeptides identified by the method of the invention and to the prophylactic and therapeutic use of these polypeptides.

Abstract: The invention provides compositions and methods for measuring human serum hepcidin levels. The invention provides methods for the oxidative refolding of a hepcidin polypeptide to a form that is mature, bioactive and folded as in the native configuration and molecular mass; a method for measuring the level of native, bioactive hepcidin in a vertebrate animal.

Abstract: A liquid reagent of a stabilized thyroid hormone-immobilized carrier, by which a thyroid hormone can be measured easily in a short time and at low cost, is provided. The liquid reagent of a thyroid hormone-immobilized carrier according to the present invention includes: a thyroid hormone-immobilized carrier; and a solvent, and a pH of the solvent containing the thyroid hormone-immobilized carrier is in a range from 8.7 to 11.5. The detection of a thyroid hormone using the liquid reagent of the present invention can be carried out by competitively binding a thyroid hormone in a sample and the thyroid hormone-immobilized carrier in the liquid reagent with an anti-thyroid hormone antibody and detecting a composite of the thyroid hormone-immobilized carrier and the anti-thyroid hormone antibody.

Abstract: Numerous diseases have been linked to the production of regulator cells. The present invention relates to the observation that the immune system is cycling in these diseases. Based on these observations, the present invention provides methods for treating diseases such as cancer and a HIV infection. The present invention also relates to methods of determining when a therapy to treat a disease characterized by the production of regulator cells should be administered to a patient.

Abstract: The present inventors successfully produced monoclonal antibodies that are specific to only soluble A beta oligomers, but do not recognize soluble A beta monomers, which are physiological molecules. It was demonstrated that the anti-bodies are useful as diagnostic/therapeutic monoclonal antibodies for Alzheimer's disease.

Abstract: The invention describes a practical and robust multi-antibody approach to the sensitive immunodetection and determination of the drug of abuse m-chlorophenyl piperazine (mCPP). The invention also describes methods and kits for mCPP detection in an in vitro sample.

Abstract: Methods of detecting individuals at risk for atherosclerosis and related vascular diseases involving the detection of IL-1? autoantibodies, as well as therapeutic methods to prevent or treat atherosclerosis and related vascular disease by administering a pharmaceutical composition comprising IL-1? autoantibodies.

Abstract: A method for determining the risk of an individual of suffering from inflammation, opportunistic infection or disruption of immunoglobulin metabolism, comprising (a) determining the level of fragmentation or modification of Fc function of immunoglobulins in a sample taken from the individual and (b) determining thereby the risk of inflammation, impaired immune response or opportunistic infection. The invention also provides the use of a trypsin inhibitor in the manufacture of a medicament for use in the treatment or prevention of a disorder associated with elevated trypsin activity which is correlated with IgG fragmentation or modification.

Abstract: The invention provides among other things methods and kits based on assaying for cardiac troponin autoantibodies, either in conjunction with an assay for cardiac troponin and/or as an independent indicator of cardiac pathology, such as myocarditis, cardiomyopathy, and/or ischemic heart disease. Assay methods of the invention can be employed among other things to identify cardiac pathology, or risk thereof, in subjects who have an autoimmune disease or who are related to an individual with an autoimmune disease. In particular embodiments, the invention also provides a method of determining whether a subject having, or at risk for, a cardiac pathology is a candidate for immunosuppressive therapy or immunoabsorption therapy. The invention also provides kits and kit components that are useful for performing the methods of the invention.

Abstract: Kit and method for the pre mortem in vitro detection of Alzheimer's disease The invention relates to a detection kit for Alzheimer's disease based on the vitro identification of the presence of biomarkers in the remains normally discarded after crystalline lens surgery. The kit can be used for the pre mortem detection of the disease, even before the appearance of clinical symptoms. Among the available biomarkers, the biomarker of choice is beta-amyloid peptide, for which several methods of sample processing and labelling for the presence of the biomarker may be used. Embodied in the invention is also the use of the crystalline lens remains discarded during surgery, often cataract surgery, to prepare a method for the in vitro pre mortem detection of Alzheimer's disease.

Abstract: There is a demand for improved turbidimetric immunoassays for human Cystatin C in biological samples, especially in human clinical samples of body fluids. The present invention provides a turbidimetric immunoassay method and reagent set enabling measurement of human Cystatin C by turbidimetric methods, resulting in a surprisingly stronger and faster turbidimetric signal than in the present state of the art. The increased and faster signal is accomplished by the use of new reagents and compositions, and enables shorter assay times and kinetic reading with a stronger signal, improving overall assay speed and quality. Improved robustness to lipid interference and improved linearity is achieved.

Abstract: Provided are methods and devices for determining the strain of a pathogen in a sample.

Abstract: One aspect of the present invention provides a method of treating or preventing angioedema in a patient in need thereof comprising administering to the patient a therapeutically effective amount of an agent that is capable of inhibiting the interaction of HK with gC1q-R. One aspect of the present invention provides a method of treating or preventing vascular permeability in a patient in need thereof comprising administering to the patient a therapeutically effective amount of an agent that is capable of inhibiting the interaction of HK with gC1q-R.

Abstract: The present inventors successfully produced monoclonal antibodies that are specific to only soluble A beta oligomers, but do not recognize soluble A beta monomers, which are physiological molecules. It was demonstrated that the antibodies are useful as diagnostic/therapeutic monoclonal antibodies for Alzheimer's disease.

Abstract: A method for the multiplexed diagnostic and genetic analysis of enzymes, DNA fragments, antibodies, and other biomolecules comprises the steps of constructing an appropriately labeled beadset, exposing the beadset to a clinical sample, and analyzing the combined sample/beadset by flow cytometry. Flow cytometric measurements are used to classify, in real-time, beads within an exposed beadset and textual explanations, based on the accumulated data obtained during real-time analysis, are generated for the user. A secondary reagent, such as a metal or magnetic particle, is added to the beadset to assist in the analysis. Detection techniques, such as such as light scatter, Rayleigh scatter, Raman scatter, surface plasmon resonance, magnetic induction, or magnetoresistance are used to detect the particle labels.

Abstract: The present invention provides a method for detecting autoantibodies to osteoprotegerin (OPG). The method comprises the step of providing a biological sample from a subject with, or at risk of osteoporosis and detecting whether or not any antibodies against osteoprotegerin (OPG) are present in said sample. In addition the invention provides methods useful in aiding the diagnosis/prognosis and/or therapeutic regimen for autoimmune and/or vascular disease in general.

Abstract: Bodily fluid is analyzed for the presence of drugs of a selected panel of drugs in a simultaneous assay in which sample of the fluid is incubated with additional amounts of all drugs of the panel, antibodies specific to each of the drugs of the panel, and microparticles, the microparticles being divided into subsets, one subset for each drug in the panel and each subset distinguishable from the others. The incubation is performed in a liquid medium in which competitive binding occurs, the drugs in the sample competing with those added to the assay medium for binding to the antibodies. In one procedure, the added drugs are pre-coupled to the microparticles while the antibodies are not, and the incubation is followed by further incubating the microparticles with labeled ligands that have affinity for the antibodies.

Abstract: Disclosed are human antibodies that specifically inhibit VEGF binding to only one (VEGFR2) of the two primary VEGF receptors. The antibodies effectively inhibit angiogenesis and induce tumor regression, and yet have improved safety due to their specificity. The present invention thus provides new human antibody-based compositions, methods and combined protocols for treating cancer and other angiogenic diseases. Advantageous immunoconjugate compositions and methods using the new VEGF-specific human antibodies are also provided.

Abstract: An analytical strip and a detecting method using the analytical strip are provided. The analytical strip includes a substrate having a channel thereon. The channel has a first region, a second region and a third region, which are arranged successively. A first antibody is localized in the first region. A saccharide and a peroxidase are localized in the first or second region. A second antibody for recognizing a different epitope of an identical antigen with the first antibody is immobilized in the second region. A substrate reagent including a saccharide oxidase is localized in the third region.

Abstract: The present invention primarily relates to a method for analyzing the amount of immunoregulatory integrin binding factors and/or patient endogenous antibodies which are directed against such factors, the factors having the capacity to modulate the immune functions in a subject suffering from cancer or inflammatory or autoimmune diseases, by utilizing binding reagents to determine these factors and/or the patient endogenous antibodies which are directed against such factors, whereby the prognosis and/or the therapeutic efficacy of any treatment of a subject suffering from cancer or inflammatory or autoimmune diseases can be determined and/or monitored. The invention further relates to the use of therapeutically active compounds for eliminating, inhibiting or enhancing such binding factors for the manufacture of pharmaceuticals to be used in the treatment of cancer, inflammatory conditions or autoimmune diseases.

Abstract: The preparation of vitamin D compounds of formula (I) with a label attached to a spacer group in the 3 position is disclosed. In the above formula (I), O represents the oxygen atom of an ether group; Y represents hydrogen or hydroxy; A represents a label such as biotin, digoxigenin, or another vitamin D group; R represents a substituted hydrocarbon side-group of vitamin D or a vitamin D metabolite. Also disclosed is a method of measuring 25-hydroxy vitamin D metabolite and a 1?,25-dihydroxy vitamin D metabolite in a sample.

Abstract: Disclosed are assays, methods, and kits for the screening of test compounds for their capability to induce cardiotoxicity in a subject. In particular, whether a test compound has the effect to prolong the Q-T interval as measured by an electrocardiogram in a human. The assays, methods, and kits disclosed herein make use of the binding interaction between novel fluorescent tracers and the hERG K+ channel, and the propensity of a test compound to influence that binding interaction.

Abstract: The present invention concerns a method for the simultaneous detection of different bacteria, comprising the following steps: coupling one or more species of bacteriophage tail proteins onto a support, incubating the support coupled with the bacteriophage tail proteins with a sample, optionally removing the sample and the bacteria of the sample not bound to the bacteriophage tail proteins, contacting the bacteria bound to the bacteriophage tail proteins with the bacteriophages and/or bacteriophage proteins specifically binding the bacteria to be detected, removing the bacteriophages and/or bacteriophage proteins not bound to the bacteria, and performing the detection reaction by means of an enzyme coupled to the specifically binding bacteriophages and/or bacteriophage proteins or by means of an immuno assay.

Abstract: The invention relates to methods and products for the identification of a clinically significant immune response in subjects treated with a therapeutic protein. A first aspect of the invention relates to methods and compositions for identifying a clinically significant immune response in patients treated with therapeutic amounts of a VLA4 binding antibody (e.g., natalizumab). A second aspect of the invention concerns the chronological details of sample collection for determining the titre of antibodies against the therapeutic protein, e.g. the collection of at least two samples at two different time points. A third aspect of the invention relates to the selection of the critical threshold level, which corresponds to the antibody titre of untreated patients increased by the double of the standard deviation of this control antibody titre.

Abstract: Novel conjugates and immunogens derived from imatinib and monoclonal antibodies generated by these immunogens are useful in immunoassays for the quantification and monitoring of imatinib or its pharmacologically active salts in biological fluids.

Abstract: The present invention pertains to the domain of brain diseases, and provides novel markers and methods for diagnosing a brain alteration in an individual, especially in patients suffering from neurodegenerative diseases such as Alzheimer's disease. The present invention also provides tools for evaluating the probability, for an individual, of developing the disease, as well as a target for identifying new drugs for treating neurodegenerative diseases such as Alzheimer's disease. In particular, the invention provides a genetic marker based on combination of two single nucleotide polymorphism, at positions ?389 and ?241 of the ornithine transcarbamylase (OTC) gene.

Abstract: Assay systems and specialized antibodies for the detection and quantitation of troponin I and troponin T in body fluids as an indicator of myocardial infarction are disclosed. Troponin I and T exist in various conformations and the ratios of monomeric troponin I and T and the binary and ternary complexes, as well as which form of troponin present in the blood, may be related to the metabolic state of the heart. Disclosed are systems to determine the presence of a troponin form or a group of troponin forms in whole blood, serum or plasma samples. Disclosed is a method for improving the recovery of troponin I or T from a surface used in immunoassays. Also disclosed are antibodies which recognize unbound troponin forms, the forms of troponin in binary complexes, the ternary complex of troponin I, T and C, and the conformations of troponin I having intramolecularly oxidized and reduced cysteines.

Abstract: Novel conjugates and immunogens derived from lenalidomide and antibodies generated by these immunogens are useful in immunoassays for the quantification and monitoring of thalidomide and lenalidomide in biological fluids.

Abstract: Methods and kits for performing a two-phase optical assay for one or more than one analyte without intrinsic optical contrast in a sample are disclosed. The method requires use of a functionalized microparticle immobilized with two or more than functional components and an additional set of one or more than one functional component. The assay can be performed in one single container and does not need a wash step.

Abstract: The present invention provides crystalline forms of an anti-LPA antibody or fragment thereof, which may further comprise a lipid ligand of said antibody and/or salts, metals, or co-factors. Methods for making such crystals and co-crystals are provided, as are methods of using structural information in antibody design or optimization. Methods for designing a humanized antibody to a lipid are provided. These methods may be performed in silico and may be intended to enhance binding affinity of an antibody to its original target lipid, and/or to alter binding specificity. Optimized variant anti-LPA antibodies are also provided.

Abstract: The present invention relates to the use of Basic Prolin-rich Lacrimal protein (BPLP) gene products, such as Opiorphin, for establishing a prognosis, a diagnosis or the monitoring of a pathological state or of treatment efficacy in a subject and the related method of use.

Abstract: [PROBLEMS] To reduce the amount of, for example, a capturing antibody to be employed without lowering detection sensitivity. At the same time, to enable the achievement of intense color development or light emission in a determination area even in the case where only a small amount of a labeled antibody is accumulated. To lower the detection limit in the sandwich method. To enlarge the dynamic range in the competition method. [MEANS FOR SOLVING PROBLEMS] A method of analyzing a test substance by an immunological analysis method by using the test substance, a support having a determination area, on which one member selected from a capturing antibody capable of binding specifically to the test substance and a capturing antigen capable of binding specifically to the test substance has been immobilized, and a labeled antibody capable of binding specifically to the test substance, wherein a label having a sensitizing effect has been immobilized on the determination area of the support.