Novel compositions, methods, assays and kits directed to a diagnostic panel for Alzheimer's disease are provided. In one embodiment, the diagnostic panel includes one or more proteins associated with Alzheimer's disease.

This invention relates to nucleotide polymorphisms in the human Apo(a) gene and to the use of Apo(a) nucleotide polymorphisms in identifying whether a human subject will respond or not to treatment with acetylsalicylic acid.

The present disclosure provides an in vitro cell based potency assay to determine the relative potency of a composition, including a pharmaceutical composition, comprising an mRNA encapsulated in a lipid nanoparticle (LNP) as compared to a reference sample. Also provided is a process for releasing or accepting a batch of a pharmaceutical composition comprising an mRNA encapsulated in an LNP using the in vitro cell based potency assay. The methods and processes described comprise (i) transfecting a population of cells with a test sample of the composition, (ii) transfecting a different population of cells with a reference sample of the pharmaceutical composition, wherein the cells in step (ii) are the same cell type as the cells in step (i); (iii) detecting the amount of expression of a polypeptide encoded by the mRNA in the transfected cells; and comparing the amount of expression, thereby determining the relative in vitro potency of the composition.

The invention relates to methods for the diagnosis of ischemia or ischemic tissue damage, methods for predicting the progression of ischemia in a patient having suffered an ischemic event, for determining the prognosis of a patient having suffered an ischemic event and for determining the risk that a patient suffering from stable coronary disease suffers a recurrent ischemic event based on the detection of the levels of glycosylated Apo J. The invention relates as well to a method for the determination of glycosylated Apo J in a sample.

The invention concerns methods for early detection, monitoring and prognosis of a flavivirus-induced infection, comprising the detection of a complex formed by the flavivirus non-structural glycoprotein NS1 and plasma lipoprotein particles in a biological anti-NS1 Mab sample during the clinical phase of the infection.

The present invention provides compositions and methods having improved specificity and sensitivity for the pre-operative assessment of ovarian tumors (e.g., symptomatic and asymptomatic adnexal mass) in a variety of subjects (e.g., pre- and post-menopausal women) having a variety of ovarian cancer types (e.g., low malignant potential, intermediate malignant potential, high malignant potential).

The invention relates to methods of diagnosing, prognosing, or monitoring or staging the progression of non-alcoholic fatty liver disease (NAFLD) using biomarkers. The invention also relates to a method of scoring to determine the severity of NAFLD, and a method of treating NAFLD.

Provided is a method of assisting the detection of nonalcoholic steatohepatitis (NASH), which is far less invasive than liver biopsy and is based on simple operations that do not require skilled technical personnel.

The present invention is a method of assisting the detection of NASH, which includes: a) measuring the amount of LDL-TG contained in a test blood sample isolated from a living body; b) measuring the amount of at least one component selected from the group consisting of LDL-C, LDL subfraction-C, IIDL-C, HDL subfraction-C, ApoB, ApoE, total cholesterol, ALT, and AST contained in the test blood sample; and c) determining the possibility of developing and/or having NASH by using the amount of LDL-TG in combination with the amount of the at least one component.

Provided herein are compositions, systems, kits, and methods for expressing a peptide of interest, such as Apolipoprotein H (ApoH), also known as β2-glycoprotein I (β2GPI), at increased levels using a non-ApoH signal peptide (e.g., a signal peptide that permits increased protein export from cells). Also provided herein are compositions, systems, kits, and methods for employing such recombinant ApoH with a non-ApoH signal peptide to detect subject Apolipoprotein H antibodies in a sample from a subject (e.g., to diagnose antiphospholipid syndrome in a subject).

Methods and devices for diagnosing, monitoring, or determining diabetic nephropathy or an associated disorder in a mammal are described. In particular, methods and devices for diagnosing, monitoring, or determining diabetic nephropathy or an associated disorder using measured concentrations of a combination of three or more analytes in a test sample taken from the mammal are described.