US FDA approves first blood test for detecting concussion

Desiree Steele
February 16, 2018

Most people who present with concussion symptoms, like impaired memory, problems with movements or sensations, or compromised emotional function, turn out to have negative CT scans, the FDA said. And it's just the latest example of technology striving to revolutionize how we diagnose diseases and injuries by making tests less invasive (and health care less costly).

The Brain Trauma Indicator can rule out the need for a CT scan in at least one-third of patients with suspected mild TBI, according to the FDA. A sizeable number do not, as the FDA points out.

The test, which measures levels of two proteins in blood, does not by itself provide a firm yes/no as to whether a patient has suffered a brain injury.

For now, the Brain Trauma Indicator is only approved for adults, but Banyan Biomarkers plans to conduct clinical trials that will evaluate if it's effective in children who have sustained a head injury.

"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 health care system the cost of often unnecessary neuroimaging test", Gottlieb added.

The move means Banyan Biomarkers can commercialize its test, giving the San Diego-based company an edge in the biotech industry's race to find a way to diagnose concussions. "The FDA's audit group worked intimately with the test engineer and the U.S. Branch of Defense to assist a blood test for the assessment of mTBI that can be utilized both in the mainland U.S. and also outside U.S. research centers that administration the American military". The proteins begin to spike as soon as 15 minutes after the injury occurs, and the blood test can still detect the lingering markers of a concussion as long as 12 hours after the fact.

Traumatic brain injuries contributed to about 2.8 million emergency room visits and almost 50,000 deaths in 2013, according to data from the Centers for Disease Control and Prevention.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. It also shows that absence of the two proteins in the test is a good indication that CT scans will be normal.

"That's what we'd like to have for the brain", he said. And that's where Banyan's blood test can help. The Brain Trauma Indicator could foresee the nearness of intracranial sores on a CT filter 97.5 percent of the time and the individuals who did not have intracranial sores on a CT examine 99.6 percent of the time.

The FDA approved the marketing of the first blood test to assess concussion in adults, known as the Brain Trauma Indicator.

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