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Help is on the way for emergency department (ED) clinicians trying to determine which potential concussion patients should be scanned.
The FDA recently approved marketing for the first blood test to evaluate mild traumatic brain injury (mTBI). The Breakthrough Devices Program was employed to speed approval of the Banyan Brain Trauma indicator in less than six months.
The 15-point Glasgow Coma Scale is currently used in EDs to evaluate suspected head injury. CT of the head is often the next step in hopes of detecting intracranial lesions requiring treatment.
The problem is that in most patients with mTBI intracranial lesions aren’t detectable after a CT scan, making the expense and radiation exposure unnecessary.
FDA officials suggest that availability of a blood test for concussion will help improve decision-making on the need for CT scans and help avoid unnecessary neuroimaging and associated radiation exposure to patients.
“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 modernized standard of care for testing of suspected cases,” FDA Commissioner Scott Gottlieb, MD, says. “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.”
The CDC reports that EDs had about 2.8 million visits in 2013 for TBI-related injuries. While TBI can range from mild to severe, the overwhelming majority of cases, 75%, fall into the first category and usually result in negative CT scans.
The Brain Trauma Indicator, used within 12 hours of head injury, measures UCH-L1 and GFAP proteins that are released from the brain into blood. Levels of the proteins can help predict which mTBI patients are likely to have visible intracranial lesions with CT scans. Test results are available in three to four hours, according to the FDA report.
FDA approval to Banyan Biomarkers, Inc., was granted based on data from a multicenter, prospective clinical study of 1,947 individual blood samples from adults with suspected mTBI or concussion. Researchers determined that the Brain Trauma Indicator predicted the presence of intracranial lesions on a CT scan 97.5% of the time, and those who did not have intracranial lesions on a CT scan 99.6% of the time.