FDA approves first blood test for concussion

Blood Test for Concussion OK'd

U.S. regulators have approved the first blood test to diagnose concussions.

Trial data involving almost 2,000 individuals with with suspected concussion or mild traumatic brain injury (mTBI) showed that the test was 97.5% accurate in identifying those with visible lesions on CT scans, and 99.6% accurate in predicting those who did not show such lesions. "Today's action supports the FDA's Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging-an effort to ensure that each patient is getting the right imaging exam, at the right time, with the right radiation dose", said FDA Commissioner Scott Gottlieb, M.D.

In a statement released on Wednesday, Feb. 14, the FDA said that this test could save money and even reduce a patient's exposure to radiation. The test should be performed within 12 hours of injury; results are available in 3-4 hours, the FDA said.

Cleveland Clinic Concussion Center director Jay Alberts said that the blood test will be most useful in assessing mild head injuries when it isn't clear if someone has concussion.

Currently, it's routine to order a CT scan for all patients with suspected closed head injuries, the FDA noted, but most scans do not show detectable lesions.

Patients with a positive test would need a CT scan to confirm the results and determine if surgery or other treatment is needed.

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When compared with a CT scan, the blood test was 97.5% as effective in detecting concussion and 99.6% effective in ruling out concussion.

Traumatic brain injuries contributed to about 2.8 million emergency room visits and almost 50,000 deaths in 2013, according to data from the Centers for Disease Control and Prevention. Of these cases, concussion-related head injuries contributed to the deaths of almost 50,000 patients. "So this blood test precedes a CT scan unless you're showing signs of extreme trauma".

"Banyan BTI has shown that these two specific protein biomarkers, which are released from the brain and circulate in the blood after a brain injury, can provide objective data to healthcare providers when evaluating patients with a traumatic brain injury", said Banyan Biomarkers CEO Henry Nordhoff.

Bazarian called the test "a huge step" toward devising a blood test that can detect brain injuries including concussions.

Patients are now diagnosed with concussion based on a combination of symptoms as well as imaging. It is manufactured by Banyan Biomarkers Inc., in Alachua, Florida. It has licensed the use of both proteins in Banyan's test to be used with its own technology.

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