The present invention is directed to methods for detecting a melanoma, methods for determining whether a melanoma is stable or progressive, methods for evaluating the extent of surgery resection in a subject having a melanoma, and methods for determining a response by a subject having a melanoma to a therapy.

The present invention is directed to methods for detecting a plasma cell dyscrasia like myeloma or MGUS, methods for determining whether a plasma cell dyscrasiais stable or progressive, methods for determining a risk for disease relapse, and methods for determining a response by a subject having a plasma cell dyscrasia to a therapy.

The disclosure provides biomarkers for diagnosis and monitoring of transthyretin (TTR) amyloidosis. The disclosure further provides methods for selection of agents for treatment of TTR amyloidosis using the biomarkers. The disclosure further provides kits for practicing the methods provided herein.

The invention relates to assay methods and kits for assessing autoimmune diseases in a human subject. In embodiments, the present disclosure provides assay methods and kits for diagnosing a subject with or predicting that a subject will develop Type 1 diabetes. In embodiments, the present disclosure provides assay methods and kits for assessing responsiveness of a subject having Type 1 diabetes to treatment with alefacept. In embodiments, the present disclosure provides assay methods and kits for diagnosing a subject with systemic lupus erythematosus. In embodiments, the present disclosure provides assay methods and kits for determining if a subject is at risk of a systemic lupus erythematosus flare. In embodiments, the present disclosure provides assay methods and kits for diagnosing a subject with celiac disease.

The invention relates to a method of determining the likelihood of an individual transitioning to a first episode of psychosis (FEP), the method comprising determining the level of selected markers in a bodily fluid sample from the individual, wherein the increase or decrease in the markers is predictive of the individual transitioning to a first episode of psychosis (FEP). The invention also relates to a method of predicting the functional outcome for an individual following a first episode of psychosis (FEP), the method comprising determining the level of selected markers in a bodily fluid sample from the individual, wherein the increase or decrease in the markers is predictive of an increased risk of functional disability outcome for the individual.

Compositions and methods are provided to determine occupancy level of opioid receptors in a subject. The disclosed methods may be performed non-invasively in the inner ear of the subject, and may be performed at a point-of-care location to provide guidance to a practitioner on tapering on pharmacotherapy or on a patient's risk of relapse for substance abuse.

The present disclosure provides, among other aspects, codon-altered polynucleotides encoding Factor VIII variants for expression in mammalian cells. In some embodiments, the disclosure also provides mammalian gene therapy vectors and methods for treating hemophilia A. In some embodiments, the present disclosure provides methods for dosing a hemophilia A patient with a polynucleotide, e.g., a codon-altered polynucleotide, encoding a Factor VIII polypeptide.

The present disclosure provides, inter alia, compositions and methods for harnessing the immune system (e.g., T cells) as a detection tool to diagnose and predict cancer patient treatment outcomes and for monitoring the persistence of functional, non-genetically modified, T cell therapies in vivo after administration to a subject.

In one aspect, methods of diagnosing a subject as having Alzheimer's disease and prognosing a subject as being at risk of progressing to Alzheimer's disease are provided. In some embodiments, the method comprises determining one or more of the level of expression of rhotekin 2 (RTKN2), the level of expression of microtubule-associated Ser/Thr kinase 4 (MAST4), the level of binding of forkhead box O1 (FOXO1) to the RTKN2 promoter, and the level of binding of amyloid precursor protein (APP) to the MAST4 promoter in a sample from the subject.

Provided is a method for diagnosing a subject having or at risk of having mild cognitive impairment (MCI), including stimulating T cells in a biological sample obtained from the subject with an amyloid β peptide or a fragment thereof and evaluating a magnitude of a T cell response toward the amyloid β peptide or the fragment thereof. Also provided is a kit for diagnosing MCI by using the method.