Now, for the first time ever, the FDA has approved a new type of blood test that can detect a concussion with incredible accuracy, and faster than ever before. And it's just the latest example of technology striving to revolutionize how we diagnose diseases and injuries by making tests less invasive (and health care less costly). The FDA reviewed the product's performance by comparing blood test results with CT scan results. A sizeable number do not, as the FDA points out.
The test is created to detect two brain cells' proteins that can drain into the bloodstream after a head injury. That means going forward, the Banyan test will be the basis upon which the FDA reviews new blood tests for brain injury developed by Banyan or other companies. "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. "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". The test can be taken within 12 hours of injury, and results can be obtained within three or four hours. The proteins involved are UCH-L1 and GFAP, which can be detected in elevated levels within 15 to 20 minutes of injury.
Traumatic brain injuries affect an estimated 10 million people globally each year; at least 2 million of them are treated in USA emergency rooms.
The findings indicate that the test can reliably predict the absence of intracranial lesions.
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She added: "In light of these allegations, we will be reviewing our association with Oxfam as a participant volunteering provider".
Lt. Col. Kara Schmid, project manager for the Army's Neurotrauma and Psychological Health Project Management Office, said Wednesday that the newly approved assay "will provide a remarkable capability for the way we evaluate and care for our service members with TBI". The test accurately predicted the presence of brain lesions 97.5% of the time, proving its mettle as a new tool in brain injuries.
To address such injuries, Banyan Biomarkers has partnered Quanterix to develop another test to detect the impact of repeated hits.
The blood test for concussions and other traumatic brain injuries will initially be used in emergency rooms and could eventually be used to treat possible head injury victims in sports and the military, the AP reported.