FDA Okays First Concussion Blood Test--but Some Experts Are Wary

The U.S. Food and Drug Administration last week gave its first green light to a company that wants to start selling a blood test to evaluate for mild traumatic brain injury, or concussion. The agency lauded the blood test as an innovative tool for speeding diagnosis and avoiding radiation exposure from brain scans. But some head trauma experts worry the authorization was pushed through too hastily.

“The data aren't as conclusive as we would have hoped, so I was surprised by the rapid FDA approval,” says Henrik Zetterberg, a professor of neurochemistry at the University of Gothenburg in Sweden, who was not involved with the project. The Brain Trauma Indicator, developed by San Diego–based biotechnology company Banyan Biomarkers, was reviewed and authorized for commercialization in fewer than six months. It was cleared under the FDA's Breakthrough Devices Program—an approvals process that aims to fast-track the development of promising and relatively low-risk medical technologies, after reviewing available data. Banyan says the new test will soon be available in hospitals.

Source :- scientificamerican