FDA gives green light to concussion blood test tool for the first time
The US Food and Drug Administration (FDA) recently gave a green light to a company that allows it to sell blood testing tools to assess mild traumatic brain injury or concussion. According to the Scientific American website, the FDA believes that this blood test can speed up the diagnosis and avoid excessive exposure of the brain to the scanning rays.
The biotechnology company, Banyan Biomarkers, from San Diego, developed a brain trauma indicator that passed the review and commercialization license in less than six months. This FDA is known as the “Breakthrough Device Program†approval process, which aims to quickly track promising and less risky medical technology advances by reviewing available data. Banyan said the new test will soon be available in hospitals.
Plasma levels of UCH-L1 (a protein that helps treat brain cell waste) and GFAP (a structural protein of astrocytes found in non-neuronal cells) are two important indicators of brain trauma. Within 20 minutes after a brain injury, the two proteins can be found by blood test, and the doctor takes a long time to get results from the laboratory.
Concussion is usually assessed by a series of physical tests used to determine the level of consciousness, and then a computed tomography (CT) scan of the head. However, CT scans are expensive and many patients with suspected brain damage do not show visible damage. Blood tests can provide a relatively quick screening tool to help diagnose.
The FDA examined clinical data from nearly 2,000 blood samples from suspected concussed patients and concluded that the test had an accuracy of 99.5% in predicting CT scans, allowing at least one-third of patients. Head CT scans are no longer performed.
However, some head trauma scholars believe that the FDA's mandate is too hasty, and that more research results need to be examined before approving these innovative tools. (Technology Daily)
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