FDA Approves First Blood Test For Concussions


The blood test measures levels of proteins UCH-L1 and GFAP that are released from the brain into blood and measured within 12 hours after the head injury happened.

The test, known as the Banyan Brain Trauma Indicator, can help a physician determine whether there is a need for further testing via CT scan, helping a large portion of patients to avoid unnecessary exposure to radiation.

The FDA has approved the blood test for concussions as part of its Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging. 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.

For the moment, it is expected to be available in Emergency Rooms in the USA hospitals this year but it will be double-checked by a CT scan. CT scans are a type of souped-up X-ray, which cost money and deliver radiation.

"With extensive clinical research and scientific validation, Banyan BTI has shown that these two specific protein biomarkers, which are released from the brain and circulate in the blood after a brain injury, can provide objective data to healthcare providers when evaluating patients with a traumatic brain injury", said Henry L. Nordhoff, Chairman and CEO of Banyan Biomarkers.

Most patients with a suspected head injury are examined using a neurological scale, called the 15-point Glasgow Coma Scale, followed by a computed tomography or CT scan of the head to detect brain tissue damage, or intracranial lesions, that may require treatment; however, a majority of patients evaluated for mTBI/concussion do not have detectable intracranial lesions after having a CT scan.

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The approval goes to San Diego diagnostics developer Banyan Biomarkers.

The blood test from Banyan Biomarkers Inc. could be useful in diagnosing brain injuries that lead to an estimated 2.5 million emergency-room visits each year. The company's test returns results within four hours. Those are incredibly good odds, and considering the test costs as little as one-tenth as much as a CT scan, it's a huge win for modern medicine.

The blood test for concussions and other traumatic brain injuries will initially be used in emergency rooms and could eventually be used to treat possible head injury victims in sports and the military, the AP reported.

"If there is doubt if the person has a head injury, they will get this new blood test".

Quanterix is also working to develop a blood test to diagnose concussions and other brain injuries.