NEURAL PROTEINS AS BIOMARKERS FOR NERVOUS SYSTEM INJURY AND OTHER NEURAL DISORDERS

• US 20100317041A1
• Filed: 06/24/2010
• Published: 12/16/2010
• Est. Priority Date: 04/15/2004
• Status: Active Grant

• Current Assignee: Banyan Biomarkers, Inc. (Compagnie Merieux Alliance SAS), University of Florida Research Foundation, Incorporated (State University System of Florida)
• Original Assignee: Banyan Biomarkers, Inc. (Compagnie Merieux Alliance SAS), University of Florida Research Foundation, Incorporated (State University System of Florida)
• Inventors: LIU, MING-CHENG, OLI, MONIKA, WANG, KA-WANG (KEVIN)
• Granted Patent: US 8,492,107 B2
• Time in Patent Office: Days
• US Class Current: 435/7.92
• CPC Class Codes: A61B 5/4064 Evaluating the brain A61B5/031, A61B5/369, A61B5/14553 take precedence
• CPC Class Codes: C07K 16/18 against material from animals or humans
• CPC Class Codes: C12Q 1/6883 for diseases caused by alterations of genetic material
• CPC Class Codes: C12Y 304/19012 Ubiquitinyl hydrolase 1 (3.4.19.12)
• CPC Class Codes: G01N 2800/28 Neurological disorders
• CPC Class Codes: G01N 2800/52 Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
• CPC Class Codes: G01N 33/6896 Neurological disorders, e.g. Alzheimer's disease

Abstract

The present invention identifies biomarkers that are diagnostic of nerve cell injury and/or neuronal disorders. Detection of different biomarkers of the invention are also diagnostic of the degree of severity of nerve injury, the cell(s) involved in the injury, and the subcellular localization of the injury.

Claims

1. A method of determining the presence of traumatic brain injury (TBI) in a subject, comprising:

measuring the amount of neurensin (p24) in a sample of cerebral spinal fluid (CSF) or blood from a subject at a time within and up to about 84 hours following occurrence of a suspected TBI; and

comparing the amount of p24 in said sample with the amount of p24 in a respective s ample from an uninjured subject;

wherein a higher amount of p24 in the subject sample relative to the amount in a CSF or blood sample from the uninjured subject is indicative of TBI in the subject suspected of having the TBI.

2. The method of claim 1 further comprising measuring the amount of UCH-L1 and synuclein, UCH-L1 or synuclein in a sample from said TBI subject wherein a higher amount of any or all of p24, UCH-L1 and synuclein relative to the amount in a CSF or blood sample from an uninjured subject is indicative of TBI in the subject suspected of having the TBI.

3. The method claim 1, wherein the sample is CSF.

4. The method of claim 1 wherein the blood sample is separated into serum or plasma before analysis.

5. The method of claim 2 wherein the amount of p24, UCH-L1 and synuclein is detected using an immunoassay.

6. The method of claim 5 wherein the immunoassay is an ELISA.

7. The method of claim 2 wherein the synuclein is alpha or beta synuclein.

8. A kit for diagnosing neural brain injury in a subject, the kit comprising:

a substrate for holding a biological sample isolated from a subject suspected of having a neural brain injury;

one or more agents, each specifically detecting one of a biomarker selected from neurensin (p24), UCH-L1, alpha-synuclein and beta synuclein; and

printed instructions in accordance with claim 1 for measuring the amount of one or more of p24, UCH-L1, alpha-synuclein and beta-synuclein in the biological with said agent.

9. The kit of claim 8 wherein the one or more agents is an antibody that specifically detects and binds with one of p24, UCH-L1 or synuclein.