Diagnostics developer Banyan Biomarkers has secured marketing clearance from the US Food and Drug Administration (FDA) for a new blood test to assess mild traumatic brain injury (mTBI) or concussion in adults.
The Banyan Brain Trauma Indicator is expected to eliminate the need for unnecessary neuroimaging / CT scans and related radiation exposure in patients suspected to have mTBI.
It is designed to detect two brain-specific protein biomarkers called ubiquitin carboxy-terminal hydrolase-L1 (UCH-L1) and glial fibrillary acidic protein (GFAP), which are released into the blood after a head injury and remain for 12 hours.
The measurement of these blood proteins will enable identification of patients who may or may not have intracranial lesions that will be visible on a CT scan. The test delivers results in three to four hours.
The prediction of a low intracranial lesion probability is expected to assist healthcare professionals in deciding the requirement for a CT scan.
FDA Commissioner Scott Gottlieb said: “A blood-testing option for the evaluation of mTBI / concussion not only provides healthcare professionals with a new tool but also sets the stage for a more modernised standard of care for testing of suspected cases.
“In addition, availability of a blood test for mTBI / concussion will likely reduce the CT scans performed on patients with concussion each year, potentially saving our healthcare system the cost of often unnecessary neuroimaging tests.”
Banyan Biomarkers submitted findings from a multi-centre clinical study that involved 1,947 individual blood samples from adults with suspected mTBI / concussion.
When mTBI / concussion blood tests results were compared with CT scan results, the Brain Trauma Indicator was found to have predicted the presence of intracranial lesions on a CT scan in 97.5% of the cases and detected the absence of such lesions 99.6% of the time.
Based on this data, the FDA concluded that the test is reliable in predicting the absence of intracranial lesions and can be used in the standard of care to rule out the need for a CT scan in a minimum of one-third of patients suspected of having mTBI.