US FDA approves first blood test for detecting concussion

US FDA approves first blood test for detecting concussion

Brain Trauma Indicator blood test
(Photo: AP/Denis Poroy)

SINGAPORE: A blood test to help detect concussions in adults was approved by the US Food and Drug Administration (FDA) on Wednesday (Feb 14).

Called the Brain Trauma Indicator, it measures two biomarkers that are released when the brain is injured. The proteins involved are UCH-L1 and GFAP, which can be detected in elevated levels within 15 to 20 minutes of injury. The manufacturer Banyan Biomarkers said that the test can be taken within 12 hours of injury. Results can be obtained within three or four hours.

FDA approved the test following a clinical study of 1,900 blood samples from people with concussion or mild traumatic brain injury. When compared to a CT scan, the Brain Trauma Indicator was 97.5 per cent as effective in detecting concussion and 99.6 per cent in ruling out concussion, according to the online article published on Feb 14.

FDA director Scott Gottlieb said in a press statement that the test could “ensure that each patient is getting the right imaging exam, at the right time, with the right radiation dose”.

Hank Nordhiff, chairman and CEO of Banyan Biomarkers, said that the test would cost closer to US$150, compared to the US$800 to US$1,500 fee for a CT scan.

"Over 90 per cent of CT scans (for concussion) are negative. And you get 200 times the radiation of a chest X-ray. It's expensive; it's not terrific,” he said in the same article.

"A blood test that accurately, reliably and consistently detects the presence of brain proteins that appear in the blood after a brain injury is a major advance," said Dr David Dodick, a fellow of the American Academy of Neurology, who 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. "These occur much more often than actual concussions, especially in certain collision and contact sports,” he said.

To address such injuries, Banyan Biomarkers has partnered Quanterix to develop another test to detect the impact of repeated hits. 

Source: CNA/bk