Assays and methods for diagnosing and treating autoimmune diseases. Particularly, the invention provides methods for differential diagnosis of specific autoimmune diseases, including autoimmune rheumatic disorders.

Described herein are methods, compositions, kits, and systems for detecting free and bound PlGF, and using detection of such species to distinguish between pregnant women with or without preeclampsia or related conditions.

This disclosure describes methods and compositions for detecting the presence of autoantibodies associated with autoimmune polyglandualar syndrome 1 (APS1) in a biological sample. In particular, detection of APS1-specific autoantibodies that specifically bind to certain APS1 associated autoantigens in such methods is described. Also provided are methods of treating subjects with APS1 or at risk of developing APS1 associated conditions. Also provided are devices and kits useful for the diagnosis and prognostic assessment of subjects having APS1 and for assessing subject risk at developing particular APS1-associated conditions.

Methods for predicting the development of sepsis in a subject at risk for developing sepsis are provided. In one method, features in a biomarker profile of the subject are evaluated. The subject is likely to develop sepsis if these features satisfy a particular value set. Methods for predicting the development of a stage of sepsis in a subject at risk for developing a stage of sepsis are provided. In one method, a plurality of features in a biomarker profile of the subject is evaluated. The subject is likely to have the stage of sepsis if these feature values satisfy a particular value set. Methods of diagnosing sepsis in a subject are provided. In one such method, a plurality of features in a biomarker profile of the subject is evaluated. The subject is likely to develop sepsis when the plurality of features satisfies a particular value set.

Embodiments of the invention describe to methods of diagnosing, classifying, and/or identifying a patient's risk of developing graft versus host disease, including severe or lethal graft versus host disease, after receiving hematopoietic cellular transplantation, a transfusion or a transplantation, but before the onset of clinical symptoms.

A method for assessing the risk of potential adverse effects for a human patient receiving is provided. The method comprises determining the total B count in the patient, and identifying a B cell number indicative of a patient at risk of potential adverse effects from the antibody. The method further provides a dosing schedule for administering the antibody to the patient identified as at risk of potential adverse effects. Also provided is a pharmaceutical package or kit comprising a first dose and a second dose, and optionally a third dose, the CD19×CD3 bispecific antibody as defined in the methods/dosage regimen of the disclosure.

The present invention provides a method for quantifying a monoclonal (M-) protein in a sample of a subject, the method comprising the steps of:—subjecting a serum sample of a subject to serum protein electrophoresis (SPE) in a gel, preferably serum protein electrophoresis in an agarose gel, to separate serum proteins into different serum protein fractions, optionally followed by immunofixation electrophoresis (IFE) and further optionally involving immunostaining of the gel;—excising from said gel a gel part comprising, or suspected of comprising, a M-protein;—performing an enzymatic digestion of proteins present in said gel part in order to provide a peptide digest comprising at least one M-protein peptide;—subjecting said peptide digest comprising said at least one M-protein peptide to liquid chromatography-mass spectrometry (LC-MS) to determine a quantity of said at least one M-protein peptide, thereby quantifying said M-protein in said sample.

This document provides methods and materials related to determining whether or not a human receiving a therapy (e.g., an anti-VEGF therapy such as a bevacizumab therapy) has developed or is at risk for developing proteinuria. For example, methods and materials for detecting urinary podocytes to determine whether or not a human receiving anti-VEGF therapy has or is at risk for developing proteinuria or kidney injury are provided.

The present invention relates to biomarkers that are predictive of renal disease in patients who have diabetes. The present invention also provides methods of using such biomarkers to predict the risk that a diabetic patient will develop renal disease, and/or to identify a patient who has diabetes as being in need of a therapy to prevent or delay the onset of a renal disease.

The invention describes a method of diagnosing an individual as having an increased likelihood of having an autism spectrum disorder and in some instances, selecting a therapy. The invention is related to a system or a kit for performing such a method.