FDA Approves First Blood Test to Detect Concussion

Ebony Scott
February 17, 2018

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.

CT scan, in fact, was, until now, the only existing method to confirm the preliminary diagnosis of brain injury but it does have one big downside, namely radiation exposure. "A blood-testing alternative for the assessment of mTBI/blackout not just gives human services experts another instrument, yet in addition sets the phase for a more modernized standard of tend to testing of suspected cases". Once we can get a better handle on TBIs, we will be able to prevent more repetitive brain injury while spending less money and cause less harm.

A CT scan or MRI would still be needed if a patient experiences major changes in function after a head injury.

"A blood test to aid in concussion evaluation is an important tool for the American public and for our Service Members overseas who need access to quick and accurate tests", Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said in the news release. The company's test, called Banyan BTI (short for brain trauma indicator), measures the levels of two proteins that the brain releases into the blood in the hours following a head injury. "Moreover, accessibility of a blood test for mTBI/blackout will probably decrease the CT examines performed on patients with blackout every year, possibly sparing our medicinal services framework the cost of frequently superfluous neuroimaging tests". We are honored to have as our partner, the U.S. Department of Defense and the U.S. Army Medical Research and Materiel Command, for supporting the research and development of a diagnostic test that now provides objective quantifiable information to physicians, to eliminate unnecessary CT scans, and guide patient care'. Test results can be available within 3 to 4 hours.

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Before authorizing its release, the FDA evaluated data from a multi-center, prospective clinical study of almost 2,000 individual blood samples from adults with suspected mTBI.

Approval came based data from a clinical study of 1,947 blood samples from adults with suspected concussions, with the indicator successfully predicting the presence of intracranial lesions 97.5% of the time, and identifying those without such lesions 99.6% of the time.

The FDA says the test could be used for the general population, and will be especially helpful to the military. "It's expensive; it's not terrific", said Hank Nordhoff, chairman and CEO of Banyan Biomarkers, maker of the new test.

For the moment, it is expected to be available in Emergency Rooms in the United States hospitals this year but it will be double-checked by a CT scan.

Other reports by GizPress

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