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Brain Trauma Indicator Blood Test Approved by FDA

February 15, 2018

The United States Food and Drug Administration (FDA) signed off on the use of a first-of-its-kind blood test to assist in the detection of certain traumatic brain injuries (TBI) in adults. Banyan Biomarkers’ Banyan Brain Trauma Indicator (BTI), approved February 14, 2018, works by identifying and measuring the levels of two brain-specific proteins that appear in the blood within 12 hours of a brain injury when bleeding has occurred. The test results are available within three to four hours, although Banyan expects to reduce the time to less than an hour within the year.

Mild traumatic brain injury (mTBI), otherwise known as concussion, accounts for the majority of the 2.8 million TBIs occurring in the U.S. each year.

The current standard of care includes a CT scan to rule out the possibility of bleeding inside the skull that is often unrevealing in mTBI, is costly, and more importantly exposes the patient to radiation.

Proponents of the Banyan Brain Trauma Indicator suggest it fills a void, arguing the BTI is more effective in identifying intracranial bleeding due to TBI, safer, and less expensive. Brain injury experts, however, urge caution.

“Research and innovation in brain injury lead to better diagnostic and treatment options,” offers Dr. Gregory O’Shanick, medical director emeritus of the Brain Injury Association of America. “While an important breakthrough in the field, the threshold for detecting brain injury using the BTI is set to the finding of positive results on CT scans, which occurs in the minority of mild TBIs. The majority of concussions have negative CT studies and thus the BTI may not indicate brain injury when, in fact, the patient has sustained a mTBI.”

The BTI does not eliminate the need for proper observation, diagnoses, and intervention from licensed medical professionals after brain injury, of course, but decreases the likelihood of misdiagnosis of complicated mild traumatic brain injury and the resulting negative consequences.

Visit BIAA’s Brain Injury Information Section for more information on brain injury, diagnostic tools, and medical intervention.