Abstract: Provided herein are protein biomarkers for NETosis related diseases, including proteases. Also provided are substrate sequences of such proteases and uses thereof.

Abstract: The present disclosure highlights the relationship between extracellular mitochondrial components, optionally in combination with the secreted phospholipase A2-IIA and/or an auto-antibody, and in vivo as well as in vitro and inflammatory reactions/conditions, especially those released as a result of the degradation of a platelet. The present disclosure provides methods for determining the presence of inflammatory mediators, for limiting inflammatory reactions/conditions, for the diagnosis inflammatory reactions/conditions, for screening therapeutics for the treatment and/or the alleviation of symptoms of inflammatory reactions/conditions based on the detection or modulation of the level of these extracellular mitochondrial components.

Abstract: The invention provides TIMP2 immunoassays with improved clinical performance, particularly when used in the evaluation of renal injuries. The immunoassays rely on the selection and use of antibodies and antibody pairs that exhibit improved assay performance when used in complex clinical specimens such as biological fluids, and particularly when used in rapid assay formats such as lateral flow test devices.

Abstract: Provided herein are methods and devices for the detection of conditions or disorders by detecting altered levels of stress response pathway biomarkers. Also provided are methods and reagents for identifying panels of biomarkers associated with a condition or disorder.

Abstract: The disclosure features over 5000 methylation and acetylation sites identified in human cell line, human serum and mouse tissues, peptides (including AQUA peptides) comprising a methylation or acetylation site of the disclosure, antibodies specifically bind to a methylation or acetylation site of the disclosure, and diagnostic and therapeutic uses of the above.

Abstract: The present invention inter alia provides a method, and use thereof, of diagnosing and/or predicting atherosclerosis or CVD by detecting the lipid concentrations or lipid ratios of a biological sample and comparing it to a control and has identified specific lipid markers that are more specific and sensitive in detecting and predicting atherosclerosis and CVD than currently utilized clinical markers. Also provided is an antibody towards said lipids, and the use thereof for predicting, diagnosing, preventing and/or treating atherosclerosis or CVD. The invention additionally relates to kits comprising lipids and/or an antibody thereto, for use in the prediction and/or diagnosis of atherosclerosis or CVD.

Abstract: The present invention provides methods of detecting a target molecule in a sample comprising incubating the sample with two or more detectably labeled probes, partitioning the sample into multiple partitions, and detecting the presence of the two or more probes in the same partition.

Abstract: The present invention provides methods for predicting the likelihood of mucosal healing in an individual with inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis (UC). In addition, the present invention provides methods for monitoring the progression of mucosal healing in an individual with a disease such as IBD. Information on mucosal healing status derived from the use of the present invention can also aid in optimizing therapy and/or monitoring the therapeutic efficiency of an anti-TNF? inhibitor drug.

Abstract: Provided herein is a sandwich immunoassay for detecting cross-linked PIIINP that has at least two strands of PIIINP joined together by inter-strand cross-linking each having a C-terminal neo-epitope of PIIINP that is generated by N-protease cleavage of intact type III procollagen. A biological sample having the cross-linked PIIINP is contacted with a first surface-bound monoclonal antibody and then by a second monoclonal antibody, both specifically reactive with a neoepitope in the C-terminal sequence of PIIINP, and then binding of the second monoclonal antibody is determined. Also provided is a method for evaluating the efficacy of an antagonist drug targeting lysyl oxidases via the immunoassay and a kit containing a solid support binding the first monoclonal antibody and containing the second monoclonal antibody.

Abstract: A method for diagnosing the development of a tissue injury in a subject comprising administering a sample of neoantibodies to the subject's tissue for the purpose of detecting the presence of neoepitopes bearing complement proteins.

Abstract: The present invention provides methods for analyzing compositions of polypeptides such as antibodies by ionic strength-mediated pH gradient ion exchange chromatography. In some aspects, the methods use a combination of pH gradients and ionic strength gradients to separate the polypeptide from charge variants of the polypeptide. In some aspects, the methods use a stable ionic strength to optimize the pH gradient separation window to separate the polypeptide from charge variants. Such methods are useful for analyzing polypeptide, e.g. antibodies, with a pI greater than 9 or a pI less than 7. In some aspects, the invention provides a multiproduct method for the analysis of polypeptides of varying pI's.

Abstract: The present invention is drawn to methods for detection of the fully human antibodies infiltrated into a solid tissue, and to optimize methods for generating, selecting, and expanding monoclonal antibodies to large numbers for antibody-based therapy and diagnosis. The invention is exemplified in a number of implementations and applications, some of which are summarized below and throughout the specification. In one aspect, the invention is directed to methods for identifying potentially therapeutic fully human antibodies that have infiltrated a solid tissue comprising the following steps: (a) detecting and sorting into one or more subsets a sample of antibodies from an accessible tissue of an individual; (b) characterization of the fully human antibodies; (c) production and purification of the fully human antibody; (d) assessment of the therapeutic and diagnostic activity of fully human antibody.

Abstract: The present invention includes methods for detecting benign to malignant transformation of a cancer in a subject, comprising the steps of: collecting a sample from the subject prior to electrophoretic protein separation; activating electrophoretically separated ENOX2 transcript variants with an ENOX2 electron donor; and detecting the presence of the one or more activated ENOX2 transcript variants using a pan-ENOX2 detectable binding reagent, wherein the presence of one or more activated ENOX2 transcript variants in the sample is indicative of the malignant transformation of the cancer, whereby a 10 to 100 fold increase in detection sensitivity is obtained for the one or more activated ENOX2 transcript variants when compared to an equivalent non-activated ENOX2 transcript variant.

Abstract: Cancers of different cellular or tissue origins express different ENOX2 cancer isoforms or combinations of isoforms and shed these proteins into the circulation. Herein are disclosed methods both for cancer detection and diagnosis of particular origin, based on the patterns and molecular weights of the isoforms which allow the identification of the cell type and or tissue of origin of the neoplasm. Relative ENOX2 amounts are proportional to tumor burden and provide a reliable measure of response to therapy and disease progression. Also provided is the amino acid sequence to which the scFv antibodies bind as the molecular basis for the specificity of the test.

Abstract: This present invention relates to a screening method for rapidly identifying the hybridomas upon cell size and the expression of an exogenous label such as fluorescence labeling. This method of this present invention can largely shortens the time cost for antibody development by saving the time period with comparison of traditional methods using cell culture with media such as HAT medium.

Abstract: The present invention relates to an assay for determining endogenous levels of analyte in vivo. In particular, the present invention is directed to an assay for determining endogenous levels of stromal cell-derived factor (SDF-1) isoforms in vivo.

Abstract: A biosensor molecule comprises: a protease amino acid sequence; at least one sensor comprising at least one sensor amino acid sequence which is responsive to at least one target molecule; and an inhibitor of the protease activity of said protease amino acid sequence; wherein the biosensor is switchable from a protease active to a protease inactive state, or from a protease inactive to a protease active state when said sensor responds to said target molecule. The biosensor protease may be a protease of a virus such as a Potyvirus or a Flavivirus wherein the inhibitor is an autoinhibitory peptide derived from the virus. The biosensor may respond to the target molecule allosterically or may be cleaved by a target protease molecule.

Abstract: Compositions and methods for diagnosing an increased risk of NPSLE are provided.

Abstract: The present invention relates generally to assays, methods and kits for the prognosis and/or diagnosis of cardiac disorders. The present invention also provides, for example, binding agents to a novel class of circulating cardiac troponin T upstream open reading frame (TnTuORF) peptide biomarkers for use in predicting or diagnosing a cardiac disorder other than myocardial infarction or unstable angina. In addition, the binding agents of the present invention may be used to enhance the sensitivity and false positive performance of cardiac troponins in the prognosis and diagnosis of myocardial infarction.

Abstract: The present invention provides an autoantibody detection method that can detect an autoantibody causing an autoimmune disease with high accuracy. The autoantibody detection method of the present invention includes the steps of; causing a sample and an antigen reagent comprising a denatured protein presented by an MHC class II molecule to come into contact with each other; and detecting a complex of an autoantibody in the sample and the denatured protein in the antigen reagent. By detecting a complex of the autoantibody and the denatured protein in a biological specimen isolated from a subject according to this detection method, it is possible to test the possibility of the autoimmune disease in the subject from the detection result.