Biomarker detection process and assay of neurological condition
AssigneeBanyan Biomarkers, Inc.
InventorsKevin Ka-Wang Wang, Ronald L. Hayes, Uwe R. Mueller, Zhiqun Zhang
Life of this patent
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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.
Claims14
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.
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.
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.
Dependencies are inferred from the claim text.