First diagnostic blood test for concussion passed by the FDA
The first diagnostic blood test to evaluate the severity of a concussion has been approved for marketing by the U.S. Food and Drug Administration (FDA). The blood test can accurately and quickly identify patients with brain tissue damage, or intracranial lesions, following a head injury without the need for an expensive and time-consuming CT scan.
Generally when a person presents to a medical practitioner after a head injury, the only way to effectively diagnose that traumatic brain injury (TBI) is to undergo a CT scan. But this is extremely inefficient, given that over 90 percent of people who arrive in emergency departments with head injuries return negative CT scans.
This new blood test, called the Banyan Brain Trauma Indicator, traces two protein biomarkers that appear in a person's blood after a brain injury. Elevated levels of UCH-L1 and GFAP in the blood have been shown to effectively correlate with patients that have intracranial lesions. A recent clinical study demonstrated the blood test was 97.5 percent effective in predicting patients with intracranial lesions and even more importantly, was 99.6 percent effective in predicting patients that did not have intracranial lesions.
The blood test takes three to four hours to deliver results which means it will be a useful tool for emergency rooms and hospitals in determining which patients should utilize expensive and time-consuming CT scan resources. The U.S. Department of Defense has also expressed interest in the test, suggesting it could be of great value for the military in quickly evaluating the severity of head injuries, and whether more expansive medical is needed for patients in the short term.
"A blood-testing option for the evaluation of mTBI/concussion not only provides health care professionals with a new tool, but also sets the stage for a more modernized standard of care for testing of suspected cases," says FDA Commissioner Scott Gottlieb.
This public approval of this clinical blood test for concussion diagnosis follows years of work from researchers around the world. The company developing the blood test is further studying whether these specific blood biomarkers could be useful in monitoring recovery from TBI.