Abstract: In one or more embodiments, the present invention provides a novel biomarker which provides a link between a distinct clinical phenotype and a biochemical effect of an autoantibody on an enzyme implicated in disease pathogenesis. In particular, the present invention provides an isolated or purified human autoantibody to PAD3 protein. Methods of diagnosis of subjects for rheumatoid arthritis (RA) using these antibodies as well as diagnosis of the severity of RA in the subject, and methods for monitoring treatment of a subject with RA are also provided. The biomarkers provided herein are also useful in the diagnosis of connective tissue-interstitial lung disease (CT-ILD) in patients having or suspected of having RA.

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 one or more markers selected from the group consisting of cytochrome c and insulin-like growth factor IA as diagnostic and prognostic biomarkers in renal injuries.

Abstract: Provided are methods for predicting the risk of pre-term birth in a pregnant subject, for identifying a subject having an increased risk of pre-term birth, for selecting a subject for participation in a clinical study, and for decreasing the risk of pre-term birth in a subject.

Abstract: Provided are methods and compositions which are useful for separating, isolating, detecting, and quantifying compounds of interest which have been modified chemically, enzymatically or catalytically from other compounds which have not been so modified. The modifications may take the form of functional groups which are gained, lost or retained by the compounds of interest.

Abstract: The invention relates to a method for detecting and measuring the presence of mono-nucleosomes and oligo-nucleosomes and nucleosomes that contain particular histone variants and the use of such measurements for the detection and diagnosis of disease. The invention also relates to a method of identifying histone variant biomarkers for the detection and diagnosis of disease and to biomarkers identified by said method.

Abstract: The present invention discloses, inter alia, methods for labeling a target protein with an SHG-active probe for detection by second harmonic or sum-frequency generation in order to identify agents which bind to an allosteric site on the target protein thereby altering its structural conformation.

Abstract: There is provided herein a method for categorizing a patient having inflammatory bowel disease as being at risk for developing ankylosing spondylitis. The method comprises the use of a patient level of auto-antibodies directed against noggin (NOG) and/or sclerostin (SOST) to determine a risk for the patient developing ankylosing spondylitis. There is also provided methods of monitoring ankylosing spondylitis treatment using these auto-antibodies.

Abstract: The present invention discloses, inter alia, methods for labeling a target protein with an SHG-active probe for detection by second harmonic or sum-frequency generation in order to identify agents which bind to an allosteric site on the target protein thereby altering its structural conformation.

Abstract: Embodiments herein relate to the field of screening tools for fetal/maternal wellness, and, more specifically, to biomarkers for gestational diabetes. In various embodiments, the methods may provide non-invasive and minimally-invasive screening tools for gestational diabetes that involve detection of changes in a proteomic profile of a test sample relative to a reference sample. In particular embodiments, the method may include determining whether a proteomic profile of a test sample from the subject includes at least one expression signature characteristic of gestational diabetes, wherein the proteomic profile comprises information on the expression of glycosylated fibronectin and glycosylated PSG, for example information on levels of fibronectin-SNA or a fibronectin-antibody complex, and PSG-AAL or a PSG-antibody complex.

Abstract: Methods and apparatus for assaying the level of analytes in a sample, related to VLA-4, are disclosed. A method of decreasing the level of an anti-integrin antibody in a subject is described including a) contacting a biological sample from a subject with a detectable capture agent associated with a substrate, wherein the capture agent can bind an anti-integrin antibody in the sample; b) detecting binding of the capture agent with the level of the anti-integrin antibody; and c) treating the subject with plasma exchange until the level of the anti-integrin antibody in the sample reaches a predetermined level.

Abstract: The invention generally relates to methods for isolating proteins. In certain aspects, methods of the invention involve preparing a plurality of sample preparations, each preparation including one or more intact cells. A capture unit is introduced to a plurality of the preparations. The capture unit includes a member that transiently interacts with one or more proteins in the cells and a reactive functional group. The sample preparations are incubated, and a reaction is initiated at a different time in a plurality of the preparation. In this manner, a protein within the cell that specifically interacts with the member of the capture unit becomes bound to the capture unit via the reactive functional group to form protein/capture unit complexes. The cells are lysed and the protein/capture unit complexes are isolated.

Abstract: Provided herein are compositions and methods for examining the progression, regression or risk of individuals for having a stroke, transient ischemic attack or peripheral artery disease.

Abstract: The invention provides compositions, methods, and kits diagnosing, monitoring, and otherwise characterizing a myopathy and for detecting the presence of autoantibodies in a biological sample.

Abstract: Methods of amplifying nucleic acid on a solid support are described. Beads and template, each in known concentrations, are employed so a range of template to bead ratios can be exploited. Where the beads contain primers, the template can be amplified. After amplification, non-covalently bound template is removed, so as to leave beads with extended primers (or beads with primers that were not extended).

Abstract: The present invention relates to a method for detecting heart damage in a patient. The invention also relates to methods for treatment of patients identified as having heart damage. The invention further pertains to methods for evaluating the efficacy of an ongoing therapeutic regimen designated to treat a damaged heart in a patient.

Abstract: The present invention provides methods and compositions for identifying fatigue, disease states associated with fatigue, recovery from fatigue and/or physical performance capability in a subject.

Abstract: The invention generally relates to the field of immunochemistry including antibody therapy, diagnostics, and basic research and specifically relates to the area of selecting affinity molecules such as natural antibodies, including artificial antibodies, antibody mimics, and aptamers. The invention relates particularly to a method of selecting affinity molecules using a homogeneous noncompetitive assay in a high throughput process.

Abstract: We describe an ELABELA polypeptide comprising a sequence CXXXRCXXXHSRVPFP (SEQ ID NO: 1), in which X signifies an amino acid residue, such as a sequence selected from the group consisting of: SEQ ID NO: 2 to SEQ ID NO: 18, preferably CLQRRCMPLHSRVPFP (SEQ ID NO: 2), or a fragment, homolog, variant or derivative thereof, which polypeptide is capable of maintaining self-renewal and/or pluripotency of a stem cell.

Abstract: This invention relates to a peptide or a corresponding peptidomimetic that binds to an anti-KIR4.1 antibody in a sample from a patient, wherein said patient having multiple sclerosis or a predisposition therefor. The present invention furthermore relates to a method for diagnosing multiple sclerosis or a predisposition for multiple sclerosis in a subject, the method comprising determining the presence of an anti-KIR4.1 antibody in a sample obtained from said subject. Also provided are novel means and methods for the therapy of multiple sclerosis.

Abstract: The present invention relates to the field of cancer. More specifically, the present invention provides methods and compositions useful for diagnosing or predicting cancer in a patient. In one embodiment, a method for identifying a patient as having cancer comprises the steps of (a) providing a formalin-fixed, paraffin-embedded or fresh frozen sample of patient tissue; (b) steaming the sample in antigen retrieval buffer; (c) incubating the sample in hydrochloric acid (HCl); (d) incubating the sample with an affinity reagent specific for 5hmC under conditions to form a complex between the affinity reagent and 5-hydroxymethylcytosine (5hmC) present in the sample; (e) detecting the complexes formed between 5hmC and the affinity reagent with secondary detection reagents; (f) quantifying 5hmC levels; and (g) identifying the patient as having cancer if the 5hmC levels in the sample are reduced as compared to a control.