The use of mitochondrial protease OMA1 as a theranostic marker for breast cancer, tumor progression, metastatis and drug responsiveness is disclosed herein.

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.

Disclosed are antibody arrays for the detection of cancer in a human or animal subject, comprising a solid support having disposed thereon in a predetermined spatial configuration, a panel of antibodies specific to biomarkers comprising CA-125, MSP-, TIMP-4, PDGF-R and OPG, wherein the panel comprises a first antibody or fragment thereof that specifically binds CA-125, a second antibody or fragment thereof that specifically binds MSP-, a third antibody or fragment thereof that specifically binds TIMP-4, a fourth antibody or fragment thereof that specifically binds PDGF-R, and a fifth antibody or fragment thereof that specifically binds OPG. Also disclosed are systems containing the arrays and methods of using the arrays to detect cancer such as ovarian cancer.

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 biomarkers selected from the group consisting of Immumoglobulin A, Metalloproteinase inhibitor 4, and Thrombomodulin as diagnostic and prognostic biomarker assays in renal injuries.

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 measured urine concentration of one or more of TIMP2 and IGFBP7 in combination with one or more of a measured serum creatinine and a measured urine output, which results are correlated to the renal status of the subject, and can be used for diagnosis, prognosis, risk stratification, staging, monitoring, categorizing and determination of further diagnosis and treatment regimens in subjects suffering or at risk of suffering from an injury to renal function, reduced renal function, and/or acute renal failure.

The disclosure provides biomarker proteins, a change in the concentration or activity level of which are associated with atypical hemolytic uremic syndrome (aHUS) or clinically meaningful treatment of aHUS with a complement inhibitor. Also provided are compositions and methods for interrogating the concentration and/or activity of one or more of the biomarker proteins in a biological fluid. The compositions and methods are useful for, among other things, evaluating risk for developing aHUS, diagnosing aHUS, determining whether a subject is experiencing the first acute presentation of aHUS, monitoring progression or abatement of aHUS, and/or monitoring response to treatment with a complement inhibitor or optimizing such treatment.

It is an object of the present invention to provide methods and compositions for protection of subjects from acute kidney injury by treating the subject with compounds that modulate the cell cycle. Modulating the cell cycle can comprise inducing G.sub.0/G.sub.1 cell cycle arrest, and/or inducing cell cycle progression. As demonstrated below, even a single administration of a compound which induces G.sub.0/G.sub.1 cell cycle arrest can protect subjects from AKI, and may be used prophylactically in advance of, or as a treatment following, various treatments or conditions that are known to be injurious to the kidney, followed optionally by release of the arrest. Once AKI is established, cell cycle progression can be induced to increase replacement of lost and damaged cells.

The present disclosure is directed toward methods for detecting brain related maladies in a subject by measuring levels of at least one of the identified biomarkers, as compared to a control. Brain related maladies include physical trauma to the brain, neurodegenerative disorders, and mental illness. The detection of the target biomarkers in ocular fluid provides a simpler and more effective sample matrix as compared to other biological matrices.

Provided are methods of treating tissue fibrosis comprising administering to a subject in need of treatment an effective amount of an agent that inhibits a hyaluron synthase (HAS) or CD44. Further provided are methods of inhibiting myofibroblast invasion, or of reducing matrix deposition in the lung, the methods comprising administering to a subject in need of treatment an effective amount of an agent that inhibits a HAS or CD44. Further provided are methods of determining the progression of pulmonary fibrosis, the methods comprising determining the level of matrix metalloproteinase expression in a cell, and comparing the level of expression to that of a control cell, wherein an increased level of expression relative to the control cell indicates progression of the disease.

The use of mitochondrial protease OMA1 as a theranostic marker for breast cancer, tumor progression, metastatis and drug responsiveness is disclosed herein.