The present invention generally relates to kits for detecting Mycobacterium avium subspecies paratuberculosis (MAP) infection and biomarkers correlated with MAP-associated diseases or disorders. The present method also relates to methods of diagnosing a subject with a MAP-associated autoimmune disease or disorder and/or determining the treatment course of a subject diagnosed with a MAP-associated autoimmune disease or disorder.

The present invention relates generally to the field of disorders of complement activation. More specifically, the present invention provides methods and compositions useful for identifying patients having a complement-mediated disease that could benefit from treatment with complement inhibitors. As described herein, the present invention utilizes patient sera and flow cytometry in the companion diagnostic assay. More specifically, the present invention comprises evaluating complement activity via cell surface deposition of C5b-9 and, in further embodiments, complement-dependent cell killing (the modified Ham assay) using patient sera.

The invention provides assays and methods for diagnosing and treating infectious diseases. The invention relates in some embodiments to urinary biomarkers and their use in the differential diagnosis of bacterial and viral infections. The invention further relates to means for determining and providing correct treatment to infection in a non-invasive manner, while minimizing antibiotic misuse.

A method of identifying a subject who is likely to be responsive to a treatment comprising an inhibitor of IL1α, or predicting the responsiveness of a subject to a treatment comprising an inhibitor of IL1α, comprising providing a sample from a subject; administering the inhibitor of IL1α to the sample; measuring levels of one or more biomarkers in the sample; and determining the pharmacodynamic or the pharmacokinetic effect of the inhibitor of IL1α based on the levels of the one or more biomarkers.

Methods and compositions for modifying the course and severity of neuropsychiatric disorders. The method includes administering a composition to a subject suffering from a neuropsychiatric disorder, wherein the composition includes a substance selected from dextromethadone, dextromethadone metabolites, d-methadol, d-alpha-acetylmethadol, d-alpha-normethadol, l-alpha-normethadol, and pharmaceutically acceptable salts thereof.

The invention provides methods and compositions to detect expression of one or more biomarkers, including FGFR3, TP53, and/or EGFR, for treating, diagnosing, and providing a prognosis for cancer, e.g., bladder cancer. The invention also provides kits and articles of manufacture for use in the methods.

The present invention provides a method of diagnosis or prognosis endometrial carcinoma, the method comprising determining the level of expression of MMP9 in a uterine aspirate fluid sample from the female genital tract. The present invention further provides kits for the diagnosis of the disease.

Disclosed are methods of identifying a secretome from a subject cell within a heterogeneous cell population when the subject cell contacts a target cell (e.g. a subject immune cell contacts a target cancer cell) or a stimulatory agent and methods of using the identified secretome to identify cells that are safe and efficacious for cellular therapies, including adoptive CAR T-cell therapies.

Subject matter of the present invention is a method for diagnosing dementia, or determining the risk of getting dementia in a subject that does not have dementia, or monitoring therapy or monitoring or guiding intervention in a subject that has dementia, or monitoring therapy or monitoring or guiding preventive intervention in a subject that is at risk of getting dementia.

A stool resuspension solution comprising a hemoglobin stabilization reagent is provided. In some embodiments, the hemoglobin stabilization reagent may be an osmolyte, a polyvalent cation, a sugar or polysaccharide and, optionally, a polyvalent cation, a protoporphyrin, or an HRP stabilization component and, optionally, a polyvalent cation. A method of stabilizing hemoglobin in a stool sample in the solution is also provided, as well as a sample collection device containing the solution.