Biomarker detection process and assay of neurological condition
AssigneeBanyan Biomarkers, Inc.
InventorsKevin Ka-Wang Wang, Ronald L. Hayes, Uwe R. Mueller, Zhiqun Zhang
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Abstract
The subject invention provides a robust, quantitative, and reproducible process and assay for diagnosis of a neurological condition in a subject. The invention provides 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.
Claims19
A process for determining the neurological condition of a subject or cells from the 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 or cells from the subject at a first time for a quantity of a first biomarker, and a quantity of at least one additional neuroactive biomarker, wherein the first biomarker is glial fibrillary acidic protein (GFAP), and wherein the first time is within 12 hours of the TBI or the suspected TBI;
- comparing the quantity of said first biomarker and the quantity of said at least one additional neuroactive biomarker to normal levels of said first biomarker and said at least one additional neuroactive biomarker;
- predicting a presence of an intracranial lesion in the subject based on the quantity of said first biomarker and said additional neuroactive biomarker relative to the normal levels of said first biomarker and said at least one additional neuroactive biomarker,
- wherein a presence of an intracranial lesion is predicted if said first biomarker and/or said at least one additional neuroactive biomarker are elevated relative to the normal levels of said first biomarker and said at least one additional neuroactive biomarker;
- wherein an absence of an intracranial lesion is predicted if said first biomarker and said at least one additional neuroactive biomarker are not elevated relative to the normal levels of said first biomarker and said at least one additional neuroactive biomarker;
- and
- performing a head CT on the subject when the presence of an intracranial lesion is predicted or
- declining a head CT on the subject when the absence of an intracranial lesion is predicted.
A method of assaying a biomarker combination after a traumatic brain injury (TBI), comprising:
- obtaining a blood or cerebral spinal fluid (CSF) 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 or CSF sample.
Dependencies are inferred from the claim text.