FDA Approves A Blood Test To Help Detect Concussions
FDA Approves Blood Test to Help Detect Concussions
Some concussions now can be ID’d quickly with a game-changing diagnostic tool just approved by the FDA.
By Stacey Colino
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February 20, 2019
The notion of having a concussion diagnosed or ruled out without relying exclusively on a doctor’s evaluation or a brain scan may seem too good to be true. But it’s now possible, thanks to a new blood test approved by the U.S. Food and Drug Administration (FDA) on February 14.
Called the Banyan Brain Trauma Indicator, the test measures levels of the proteins UCH-L1 and GFAP, which are released from the brain into the blood after a head injury and can be detected within 12 hours after the injury. Results are available within three to four hours.
It’s a potential game changer as a diagnostic tool. “Concussion is tough to diagnose,” says William Barr, PhD, the director of the neuropsychology division at the New York University Langone Medical Center in New York City and a clinician-researcher at NYU Langone’s concussion center. “It’s a clinical diagnosis and it depends heavily on the person’s report of symptoms.”
Symptoms of concussions can vary widely, ranging from headache, blurry vision, and difficulty concentrating to nausea, dizziness, and sensitivity to noise or light. Some people are forthcoming about their symptoms while others may want to conceal them to avoid being sidelined from athletic events or other activities. In some people, symptoms may appear right away; in others, they may not emerge until hours or even days after the head injury.
There were about 2.8 million visits to emergency departments for traumatic brain injuries (TBIs) in 2013, according to the Centers for Disease Control and Prevention (CDC).
“A blood test to aid in concussion evaluation is an important tool for the American public and for our service members abroad who need access to quick and accurate tests,” said Jeffrey Shuren, MD, the director of the FDA’s Center for Devices and Radiological Health in a statement.
Normally, people with a suspected head injury are examined and evaluated by a doctor using a neurological scale, followed by a CT (computed tomography) scan of the head to detect brain tissue damage or intracranial lesions. The blood test can prevent unnecessary neuroimaging and radiation exposure to patients because the proteins it detects can predict which patients are likely to have intracranial lesions apparent on a CT scan (and which ones aren’t).
“This test can potentially distinguish which patients, within a short period of time after a head injury, have structural injury to their brain that would most commonly be detected with imaging such as CT scan,” says Jamie Sue Ullman, MD, the director of neurotrauma at North Shore University Hospital in Manhasset, New York. “This may help weed out which patients require CT scans in the acute period, thus allowing people who don’t need one to avoid unnecessary radiation exposure.” Indeed, studies found that the blood test accurately predicted the presence of intracranial lesions on a CT scan 97.5 percent of the time and those who did not have intracranial lesions 99.6 percent of the time.
The downside is: Not all concussions will show up on CT scans or the blood test, Dr. Barr says. And while the blood test is sensitive in detecting the proteins released in moderate and severe TBIs, it may not pick up milder concussions that CT scans would miss, too. “It’s a big deal to develop the first test for biomarkers that tell you that a concussion occurred,” Barr says. “But it’s an early finding, and I think a lot of other biomarkers are going to come out.”
Until that happens, some experts see this as a major step in the right direction. “I do think that many people can potentially benefit from this test, including athletes involved in contact or collision sports,” says Dr. Ullman.
Video: FDA approves blood test that helps diagnose concussions
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