Methods and compositions for diagnosing brain injury or neurodegeneration

Inventors

SOREK, RACHEL • JAKOBI, KEREN • EDMONDS, DONNA

Abstract

Methods and compositions for diagnosing brain injury, neurodegeneration; or a predisposition thereto, in a subject are provided. Particularly, the present invention relates to specific antigen antibody reactivities useful in diagnosing brain injury, neurodegeneration or a predisposition thereto, in a subject.

Core Innovation

The invention describes methods for detecting and using biomarker proteins to diagnose brain injury or suspected brain injury in a subject. In at least one embodiment, the method detects biomarker protein synuclein beta (SNCB) in a biological sample obtained from the subject using a detecting assay selected from an immunoassay, an antigen probe set assay, a microarray assay, a dipstick assay, or a chip assay. The method measures the level of the detected SNCB biomarker protein and compares it to the level of SNCB biomarker protein present in a healthy control.

Diagnosis is performed when the level of the SNCB biomarker protein measured in the sample is higher than the level of the SNCB biomarker protein in the healthy control. The method includes diagnosing the subject as having or suspected of having brain injury when this threshold relationship is satisfied. The method further includes administering a brain injury treatment or therapy to the subject diagnosed as having or suspected of having brain injury.

Additional embodiments refine the biomarker measurement by measuring levels of at least one specified protein in the biological sample in combination with the SNCB approach and comparing those levels to the same proteins in the healthy control. The detecting assay can be implemented as an antigen probe set assay provided as an array that localizes and detects the biomarker protein at specific addressable locations on the array. Variants include detecting citrullinated or post-translationally modified forms of the SNCB biomarker protein and defining the healthy control as a biological sample, a panel of samples, or stored data from healthy individuals without brain injury.

Claims Coverage

The partial content provides one independent claim with a core method of detecting SNCB, comparing to a healthy control, diagnosing brain injury, and administering a brain injury treatment or therapy. Dependent claims refine the approach by expanding protein targets, specifying assay formats, defining kit-based implementation, detecting modified SNCB forms, and specifying the form of the healthy control baseline.

The claim coverage is centered on a SNCB-based diagnostic method that uses a selected detecting assay modality to quantify SNCB, compares the measured level to a healthy control, diagnoses brain injury based on increased SNCB level, and administers brain injury treatment or therapy. Dependent claim refinements include measuring additional specified proteins, using an antigen probe set array with addressable locations, performing the detecting assay as a kit, detecting citrullinated or post-translationally modified SNCB forms, and defining the healthy control as a biological sample, a panel, or stored data from healthy individuals without brain injury.

Stated Advantages

Documented Applications