US 12,339,288 B2 · Multi-protein biomarker assay for brain injury detection and outcome

Abstract

The present invention relates to the field of brain injuries. More specifically, the present invention provides methods and compositions useful in the diagnosis/prognosis/assessment of brain injuries. In a specific embodiment, a method for identifying which patients with traumatic brain injury (TBI) require a head computerized tomography (CT) scan for diagnosing acute intracranial pathology comprises the steps of (a) obtaining or collecting a sample from the patient; (b) measuring the levels of one or more biomarkers in the blood sample obtained from the patient, wherein the biomarkers comprise glial fibrillary acidic protein (GFAP), S100B, metallothionein 3 (MT3), neuron specific enolase (NSE) and intracellular adhesion molecule 5 (ICAM5); and (c) identifying the patient as requiring or not requiring a head CT scan based on the measured levels of one or more of biomarkers comprising GFAP, S100B, MT3, NSE and ICAM5.

Claims19

Dependent claims

A method of detecting protein biomarkers in a sample obtained from a patient having or at risk of having traumatic brain injury (TBI) and/or concussion, the method comprising:

(a) performing an assay comprising detecting brain derived neurotrophic factor (BDNF) and glial fibrillary acidic protein (GFAP), and one or both of neuron specific enolase (NSE) and neurogranin (NRGN) protein biomarkers in a biological sample obtained from the patient;
(b) measuring the levels of the protein biomarkers in the patient sample relative to the levels of the respective protein biomarkers in one or both of a non-TBI reference control or a non-concussion reference control;
(c) measuring no decrease in the level of the BDNF protein biomarker in the sample relative to the level in the one or both reference controls;
and/or measuring no increase in the levels of the GFAP, NSE, and/or NRGN protein biomarkers relative to the levels in the one or both reference controls;
and
(d) returning the patient to play or to work immediately based on step (c).

3 more elements

A method of managing patient treatment for traumatic brain injury (TBI) and/or concussion, the method comprising:

(a) obtaining a biological sample from a patient;
(b) performing an assay comprising detecting brain derived neurotrophic factor (BDNF) and glial fibrillary acidic protein (GFAP), and one or both of neuron specific enolase (NSE) and neurogranin (NRGN) protein biomarkers in the biological sample by using a detection method selected from the group consisting of an immunoassay, mass spectroscopy, polymerase chain reaction, biochip assay, electrochemical voltammetry, amperometry, atomic force microscopy, radio frequency techniques, multipolar resonance spectroscopy, microscopy, confocal microscopy, non-confocal microscopy, surface plasmon resonance, ellipsometry, resonant mirror technique, a grating coupler waveguide technique, and interferometry;
(c) measuring the levels of protein biomarkers in the patient sample relative to the levels of the respective protein biomarkers in one or both of a non-TBI reference control or a non-concussion reference control;
(d) measuring a decreased level of BDNF in the sample compared to the level in the one or both reference controls, and/or measuring increased levels of the GFAP, NSE and/or NRGN protein biomarkers in the sample relative to the levels of the respective biomarkers in the one or both reference controls;
and
(e) administering a brain injury therapy regimen to the patient based on step (d), thereby managing patient treatment for TBI and/or concussion.

3 more elements

Dependencies are inferred from the claim text.

Multi-protein biomarker assay for brain injury detection and outcome

Life of this patent

Multi-protein biomarker assay for brain injury detection and outcome

Life of this patent

Abstract

Claims19