FDA approves first blood test to help diagnose concussions

FDA approves first blood test to help diagnose concussions

According to the documentation released by the FDA, the blood test has the power to effectively rule out a concussion 99.6% of the time, and successfully detects brain damage in over 97% of cases.

The FDA reviewed and authorized marketing for the Banyan Brain Trauma Indicator in fewer than 6 months. Additionally, by sparing some patients CT scans, it would reduce the radiation exposure associated with those scans.

"A blood test that accurately, reliably and consistently detects the presence of brain proteins that appear in the blood after a brain injury is a major advance", said Dr David Dodick, a fellow of the American Academy of Neurology, who was not involved in the development of the test. This allows the test to diagnose a brain injury within 12 hours.

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 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. "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".

"That's what we'd like to have for the brain", he said.

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Far larger, however, will be the test's impact on civilian victims of brain trauma. Of these cases, concussion-related head injuries contributed to the deaths of almost 50,000 patients. He explained that the scans are being done to identify important brain injury that requires surgery. About three-quarters of TBIs that occur each year are assessed as mTBIs or concussions, which will probably resolve with rest.

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

The test should save money and reduce a patient's exposure to radiation, according to the FDA.

For adults, the result can be a slightly increased risk of developing cancer down the road.

The FDA is permitting marketing of the Brain Trauma Indicator to Banyan Biomarkers, Inc.

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In a clinical study conducted at several sites in Europe and North America, researchers gathered 1,947 individual blood samples from adults with suspected mTBI/concussion.

The FDA has approved a blood test for use in the detection of concussion for the first time.

Unfortunately, the newly-approved blood test might not move the needle much when it comes to brain trauma in sports.

Mr. Nordhoff said by using this device it will be easy for physicians to evaluate children for concussions. "But we are planning to do another study in adolescents", he added.

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