Today, the US Food and Drug Administration (FDA) permitted marketing of the first blood test evaluating mild traumatic brain injury (mTBI), or concussion, in adults. The test should be performed within 12 hours of injury; results are available in 3-4 hours, the FDA said.
Patients are now diagnosed with concussion based on a combination of symptoms as well as imaging.
At present, medical professional use Cat scans, which expose patients to radiation, to test for concussions and other brain injuries. Nonetheless, 99 percent of concussions do not require a CT scan because these are not clinically important and thus do not need immediate surgery. And you get 200 times the radiation of a chest X-ray.
The test should save money and reduce a patient's exposure to radiation, according to the FDA. It would also significantly lower costs to the health system, he added. Where a CT scan can cost $800 to $1,500, Nordhoff predicts that the new test would cost closer to $150. But Henry L. Nordhoff, chairman and chief executive officer of San Diego-based Banyan Biomarkers, told the Los Angeles Times on Wednesday that his company is working with the Defense Department to shorten that turnaround time to under an hour.
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That prize would be a test that could detect and guide treatment for concussions and traumatic brain injuries, similar to a blood test that hospitals commonly use to evaluate suspected heart attacks, Koroshetz said. The company plans to soon start a clinical trial evaluating injured children, .
Banyan BTI identifies two brain-specific protein biomarkers (Ubiquitin Carboxy-terminal Hydrolase-L1 or UCH-L1 and Glial Fibrilliary Acidic Protein or GFAP) that rapidly appear in the blood after a brain injury, providing objective information to assess patients with suspected mild TBI. He was not involved in the development of the test.
However, Dodick conceded that work still needs to be done, especially on "hits that don't cause symptoms but do cause a brain injury", he said. Many in the medical community believe that concussions and CTE - chronic traumatic encephalopathy, which many National Football League players have been shown to suffer from - are separate concerns.
To address such injuries, Banyan Biomarkers has partnered Quanterix to develop another test to detect the impact of repeated hits. The Brain Trauma Indicator could could also be used at sports games and in the military, the agency said. They compared the blood test's performance in predicting the need for a CT scan with actual CT scan results.