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

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

"The present activity bolsters the FDA's Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging-a push to guarantee that every patient is getting the correct imaging exam, at the opportune time, with the correct radiation measurements", said FDA Commissioner Scott Gottlieb, M.D. Levels of these blood proteins after mTBI/blackout can help anticipate which patients may have intracranial injuries obvious by CT output and which won't.

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 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. The test can be taken within 12 hours of injury, and results can be obtained within three or four hours.

"Over 90 per cent of CT scans (for concussion) are negative".

A study of almost 2,000 individual blood samples saw the Brain Trauma Indicator accurately predict the presence of intracranial lesions on CT scan 97.5 percent of the time, while correctly predicting the absence of said lesions 99.6 percent of the time.

The Brain Trauma Indicator can help doctors figure out whether or not someone with a concussion needs a computed tomography, or CT, scan to detect brain tissue damage.

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The accuracy of the results means that doctors using the test can confidently rule out concussion without having to put patients through the CT process. The test can be used to reduce radiation exposure to patients.

FDA approved the test following a clinical study of 1,900 blood samples from people with concussion or mild traumatic brain injury. The FDA says the tool could save up to one-third of patients suspected of having a concussion from extra testing.

San Diego-based Banyan has partnered with French firm bioMerieux SA to market the test to hospitals using bioMerieux's blood analyzing machines.

Due to the frequent brain injuries suffered by the U.S. soldiers in Iraq and Afghanistan, the army representatives declared that the production of blood tests to accurately depict brain trauma within hours are a necessity in conflict zones.

This breakthrough in concussion testing and diagnosis comes at a time when the long-term effects of sports-related brain trauma is a hot topic of debate. The company is also studying how its tests could be used to assess other brain conditions. Abbott has licensed both protein biomarkers from Banyan and is developing its own blood tests.

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