# US 12,601,749 B2 · Biomarker detection process and assay of neurological condition > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,601,749 B2 - Document ID: US12601749B2 - Status: Granted - Kind: B2 - Application number: 18/637,770 - Filed: 2024-04-17 - Published: 2024-08-08 - Granted: 2026-04-14 - Earliest claimed: 2008-08-11 - Assignees: Banyan Biomarkers, Inc. - Applicants: Banyan Biomarkers, Inc. - Inventors: Kevin Ka-Wang Wang; Ronald L. Hayes; Uwe R. Mueller; Zhiqun Zhang - Web page: https://patentgrep.com/patent/US12601749B2 ## CPC - G01N 33/6896: {Neurological disorders, e.g. Alzheimer's disease} - A61B 5/4064: {Evaluating the brain (for intracranial pressure A61B5/031; for cerebral blood gases A61B5/14553; using EEG A61B5/369)} - G01N 33/577: involving monoclonal antibodies {binding reaction mechanisms characterised by the use of monoclonal antibodies (G01N33/5302 - G01N33/576 take precedence)} - G01N 2800/28: Neurological disorders - G01N 2800/2871: Cerebrovascular disorders, e.g. stroke, cerebral infarct, cerebral haemorrhage, transient ischemic event - G01N 2800/52: Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis - G01N 2800/56: Staging of a disease; Further complications associated with the disease - G01N 2800/60: Complex ways of combining multiple protein biomarkers for diagnosis - G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q) - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## Abstract A robust, quantitative, and reproducible process and assay for diagnosis of a neurological condition in a subject. The method includes measurement of two or more biomarkers in a biological fluid such as CSF or serum resulting in a synergistic mechanism for determining the extent of neurological damage in a subject with an abnormal neurological condition and for discerning subtypes thereof or tissue types subjected to damage. ## Claims ### Claim 1 A process for determining the neurological condition of a subject, wherein the subject is known to have or is suspected of having a mild to moderate traumatic brain injury (TBI), wherein mild TBI is characterized as the subject having a Glasgow Coma Score (GCS) of 13-15 and moderate TBI is characterized as the subject having a GCS of 9-12, the process comprising: measuring a sample obtained from the subject at a first time for a quantity of glial fibrillary acidic protein (GFAP) and a quantity of ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1), wherein the first time is within 12 hours of the TBI or the suspected TBI; comparing the measured quantities of GFAP and UCH-L1 to normal levels of GFAP and UCH-L1, or to predetermined cutoff values of GFAP and UCH-L1; and performing a head CT on the subject when the measured quantity of GFAP and/or the measured quantity of UCH-L1 exceed the predetermined cutoff values of GFAP and UCH-L1, or declining a head CT on the subject when the measured quantities of GFAP and UCH-L1 do not exceed the predetermined cutoff values of GFAP and UCH-L1. ### Claim 2 (depends on 1) The process of claim 1, wherein the subject has a GCS of 13-15. ### Claim 3 (depends on 1) The process of claim 1, wherein the sample is plasma. ### Claim 4 (depends on 1) The process of claim 1, wherein the sample is bloom serum. ### Claim 5 A method of assaying a biomarker combination after a traumatic brain injury (TBI), comprising: obtaining a blood sample collected from a subject having the TBI within 12 hours after occurrence of the TBI; and measuring levels of ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1) and glial fibrillary acidic protein (GFAP) by assaying the blood sample. ### Claim 6 (depends on 5) The method of claim 5, wherein the blood sample is collected from the subject having a GCS of 13-15. ### Claim 7 (depends on 5) The method of claim 5, wherein the blood sample is plasma. ### Claim 8 (depends on 5) The method of claim 5, wherein the blood sample is blood serum. ### Claim 9 (depends on 5) A method of performing a head CT scan, comprising: measuring levels of UCH-L1 and GFAP by performing the method of claim 5; and performing the head CT scan on the subject when the levels of UCH-L1 and GFAP exceed predetermined cutoff values. ### Claim 10 (depends on 5) A method of refraining from performing a head CT scan on a subject having a TBI, comprising: measuring the levels of UCH-L1 and GFAP by performing the method of claim 5; and refraining from performing the head CT scan on the subject when the levels of UCH-L1 and GFAP do not exceed predetermined cutoff values. ### Claim 11 A method of assessing a subject having a mild TBI or a suspected mild TBI, to determine whether to perform a CT scan, the method comprising: measuring levels of glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal esterase L1 (UCH-L1) by assaying a blood sample collected from the subject within 12 hours of the TBI or the suspected TBI, determining whether to perform a head CT scan on the subject when the level of GFAP and/or the level of UCH-L1 exceed(s) predetermined cutoff values of GFAP and UCH-L1, or declining a head CT scan when the level of GFAP and the level UCH-L1 do not exceed the predetermined cutoff values of GFAP and UCH-L1. ### Claim 12 (depends on 11) The method of claim 11, wherein the blood sample is collected from the subject having a GCS of 13-15. ### Claim 13 (depends on 11) The method of claim 11, wherein the blood sample is plasma. ### Claim 14 (depends on 11) The method of claim 11, wherein the blood sample is blood serum.