FDA Authorizes Marketing of First Blood Test Aiding in Evaluation of Concussion


But many people who undergo these scans don't present any brain lesions that are discernible on screen, according to an FDA news release. But Wednesday's green light by the Food and Drug Administration "is a big deal because then it opens the door and accelerates technology", said Michael McCrea, a brain injury expert at Medical College of Wisconsin.

After deliberations that took less than six months, the FDA approved the marketing of the Banyan Brain Trauma Indicator to aid the evaluation of concussions in adults.

"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.

This blood test can eliminate need of CT scans in which number of people exposed to radiation.

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The move means Banyan Biomarkers can commercialize its test, giving the company an early lead in the biotech industry's race to find a way to diagnose concussions. Results can be obtained within three or four hours.

The test can help doctors identify which patients would require computed tomography (CT) scan to check if they have brain damage.

Levels of the blood proteins after mTBI can help predict patients that could have intracranial lesions visible by CT scan and those that won't.

Traumatic brain injuries affect an estimated 10 million people globally each year; at least 2 million of them are treated in US emergency rooms.

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The new test measures levels of certain proteins that are released from the brain into the blood within 12 hours of a head injury. The method of taking blood tests to diagnose brain injury was discovered some years ago but just yesterday the FDA approved it.

The test was assessed in a multi-center study involving 2,000 blood sampled from adults who had suspected concussions. It's created to help doctors quickly determine which patients with suspected concussions may have brain bleeding or other brain injury. 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. It could rule out the need for a CT scan in at least one-third of those suspected of having a concussion, the FDA said.

Mr. Nordhoff said by using this device it will be easy for physicians to evaluate children for concussions.

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