METHODS OF DETERMINING A TREATMENT PROTOCOL FOR AND/OR A PROGNOSIS OF A PATIENT'S RECOVERY FROM A BRAIN INJURY

• US 20170160292A1
• Filed: 09/19/2016
• Published: 06/08/2017
• Est. Priority Date: 04/12/2011
• Status: Active Grant

• Current Assignee: Quanterix Corporation
• Original Assignee: Quanterix Corporation
• Inventors: Wilson, David, Zetterberg, John Henrik, Blennow, Kaj, Randall, Jeffrey D.
• Granted Patent: US 10,393,759 B2
• Time in Patent Office: Days
• CPC Class Codes: G01N 2333/47 Assays involving proteins of known structure or function as defined in the subgroups
• CPC Class Codes: G01N 2333/4709 Amyloid plaque core protein
• 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 33/54306 Solid-phase reaction mechanisms
• CPC Class Codes: G01N 33/6896 Neurological disorders, e.g. Alzheimer's disease

Abstract

The present invention, in some embodiments, generally relates to methods of determining a treatment protocol for and/or a prognosis of a patient'"'"'s recovery from a brain injury. In some embodiments, the brain injury results from a hypoxic event. In some embodiments, methods are provided for determining a measure of the concentration of tau protein in a patient sample containing or suspected of containing tau protein.

Claims

1. A method for determining a measure of the concentration of tau protein in a patient sample containing or suspected of containing tau protein, comprising:

performing an assay to determine a measure of the concentration of tau protein in the sample, wherein the limit of detection of tau protein of the assay is less than about 0.2 pg/mL.

2. The method of claim 1, wherein the tau protein is tau 23 (352, 0N3R), tau 24 (383, 0N4R), tau 37 (381, 1N3R), tau 34 (412, 1N4R), tau 39 (410, 2N3R), and/or tau 40 (441, 2N4R), optionally phosphorylated.

3. The method of claim 1, wherein the patient is suspected to have a brain injury, optionally resulting from a hypoxic event.

4. The method of claim 1, wherein the sample is a bodily fluid.

5. The method of claim 4, wherein the bodily fluid is blood or a blood component.

6. The method of claim 4, wherein the bodily fluid is CSF.

7. The method of claim 5, wherein the blood component is plasma or serum.

8. The method of claim 1, wherein the measure of the concentration of tau protein is determined in a plurality of samples taken from the patient over a period of time.

9. The method of claim 8, wherein the plurality of samples are collected within 96 hours after the patient has experienced the brain injury or suspected brain injury, optionally resulting from a hypoxic event.

10. A method of determining a patient'"'"'s prognosis for recovery from, and/or determining a course of treatment for, a brain injury, wherein the prognosis and/or the course of treatment is based at least in part on the measure of the concentration of tau protein determined in the patient sample according to the method of claim 1.

11. The method of claim 10, wherein the brain injury results from a hypoxic event.

12. A method of determining a treatment protocol for and/or a prognosis of a patient'"'"'s recovery from a brain injury comprising:

performing an assay on a blood sample from the patient and/or plasma and/or serum derived from the blood sample to determine a measure of the concentration of tau protein in the sample; and

determining a prognosis of the patient'"'"'s recovery from the brain injury and/or a method of treatment based at least in part on the measured concentration of tau protein present in the sample.

13. The method of claim 12, wherein the brain injury results from a hypoxic event.

20. The method of claim 12, wherein the limit of detection for the assay is less than about 10 pg/mL, 9 pg/mL, 8 pg/mL, 7 pg/mL, 6 pg/mL, 5 pg/mL, 4 pg/mL, 3 pg/mL, 2 pg/mL, 1 pg/mL, 0.5 pg/mL, 0.1 pg/mL, 0.05 pg/mL, 0.02 pg/mL.

21. The method of claim 12, wherein the brain injury comprises a hypoxic event caused by cardiac arrest.

22. The method of claim 12, wherein the brain injury comprises a hypoxic event caused by stroke.

23. The method of claim 12, wherein the brain injury comprises a hypoxic event caused by an ischemic event.

24. The method of claim 12, wherein the brain injury comprises a hypoxic event caused by a thrombosis.

14. A method of determining a treatment protocol for and/or a prognosis of a patient'"'"'s recovery from a brain injury, comprising:

determining a prognosis of the patient'"'"'s recovery from the brain injury and/or a method of treatment based at least in part on a measured concentration of tau protein present in a patient sample, wherein the measured concentration has been determined by performing an assay on the patient sample, which comprises a blood sample from the patient and/or plasma and/or serum derived from the blood sample, to determine the measure of the concentration of tau protein in the sample.

15. The method of claim 14, wherein the brain injury results from a hypoxic event.

16-19. -19. (canceled)

25-91. -91. (canceled)