I thought this was interesting especially for our readers who treat trauma and/or pain patients.
FDA has authorized marketing of the Brain Trauma Indicator, the first blood test to evaluate mild traumatic brain injury (TBI; concussion) in adults.
Why this matters
TBI is common and can be associated with substantial morbidity and mortality.
Majority of patients with mild TBI have a negative CT scan.
A reliable biomarker would inform management and reduce unnecessary radiation exposure.
Brain Trauma Indicator (Banyan Biomarkers, Inc.) measures circulating levels of glial fibrillary acidic protein (GFAP) and ubiquitin C-terminal hydrolase L1 (UCH-L1), proteins released from the brain, within 12 hours of head injury.
Results can be available within 3-4 hours.
FDA clearance was based in part on data from a multicenter, prospective cohort study of 1947 blood samples from adult trauma patients with suspected mild TBI.
Brain Trauma Indicator correctly predicted presence of intracranial lesions on CT 97.5% of the time and absence of intracranial lesions on CT 99.6% of the time.
Results suggest the test will allow ruling out need for CT in at least one-third of patients with suspected mild TBI.
The Brain Trauma Indicator was reviewed under the De Novo premarket review pathway for selected devices, for which there is no prior legally marketed device.