FDA approves first blood test to diagnose traumatic brain injuries

The first blood test to help doctors diagnose traumatic brain injuries has won FDA approval. But, doctors in Buffalo want to make it clear: You wont be able to get a blood test to diagnose a concussion.

This test doesn’t detect concussions and the approval won’t immediately change how patients are treated. But doctors say this blood test is a big deal because it opens the door to pursuing this type of technology and perhaps finding a test for concussions down the road.

Its a race in the medical and biotech worlds to find a diagnostic test for concussions. You cant see a concussion on an MRI or cat scan, according to Dr. John Leddy with University at Buffalo Jacobs School of Medicine.
He said, “Everybody is looking for a bio-marker for a concussion, because it’s a clinical diagnosis which means sometimes that’s hard to make. There is no blood test for concussions, I want to make that clear this blood test is very specific for brain bleeding.”

The FDA approved test called, “The Banyan Brain Trauma Indicator” can detect two proteins in the brain that can leak into your bloodstream after a blow to the head.

The test is effective within 12 hours of an injury.

Traumatic brain injuries affect an estimated 10 million people globally each year. At least 2 million of them are treated in U.S. Emergency rooms. They often get CT scans to detect bleeding. And the scans expose patients to radiation.

“So we don’t want to use radiation on children or anyone, unless it’s absolutely necessary. Unless the test is going to make a difference, and I think in some cases, this blood test could help make that decision.”
Dr. Leddy says reducing unnecessary radiation exposure is great. But, he’s concerned about how this could be handled in an emergency room. “It would be concerning if someone went to the emergency room with obvious signs of a concussion, and they left thinking they didn’t have one because a blood test was negative.”
But Dr. Leddy says getting the green light from the FDA is a step towards finding a test for concussions, it’s just years down the road.

“If we had a blood test that showed a marker that was very specific for concussion,s that could be obtained, say right away, within minutes, that would be useful. But this is not that test.”
Dr. Leddy also questions whether this test will save money or resources. It’s not clear just how expensive the blood test will be. He says it may take time, perhaps years, until we learn whether it will reduce the number of CT scans, or will it contribute to higher medical care costs.

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