First blood test to help diagnose traumatic brain injuries gets FDA approval

First blood test to help diagnose traumatic brain injuries gets FDA approval

The method of taking blood tests to diagnose brain injury was discovered some years ago but just yesterday the FDA approved it. If a blood testing option is available, and given the lack of discernible lesions concussion patients may have, the test may be a preferred option combined with the Glasgow Coma Scale versus a CT scan. A sizeable number do not, as the FDA points out.

The Brain Trauma Indicator was assessed under the FDA's De Novo premarket survey pathway, an administrative pathway for some low-to direct hazard gadgets that are novel and for which there is no earlier legitimately showcased gadget.

While the blood test can not now detect concussions conclusively, it does allow doctors to scan brain cells for proteins that indicate brain bleeding and other neurological injuries after a blow to the head, the Associated Press reported. The FDA reviewed and authorized for marketing the Banyan Brain Trauma Indicator in fewer than 6 months as part of its Breakthrough Devices Program. The blood test is thus expected to cut down on these unhelpful scans and the associated radiation exposure.

The move means Banyan Biomarkers can commercialize its test, giving the San Diego-based company an edge in the biotech industry's race to find a way to diagnose concussions.

FDA director Scott Gottlieb said in a press statement that the test could "ensure that each patient is getting the right imaging exam, at the right time, with the right radiation dose". The company developed the test with partial support from a contract with the U.S. Army. "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". Elevated levels of the proteins can be detected within 15 or 20 minutes of injury. The Centers for Disease Control and Prevention has estimated that in 2013, there were roughly 2.8 million emergency department visits, hospitalizations and deaths in the USA related to traumatic brain injury, or TBI.

To address such injuries, Banyan Biomarkers has partnered Quanterix to develop another test to detect the impact of repeated hits. 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.

"That's what we'd like to have for the brain", he said. The FDA says the Banyan test was able to predict the presence of brain injury on a CT scan 97.5 percent of the time.

FDA approved the test following a clinical study of 1,900 blood samples from people with concussion or mild traumatic brain injury.

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