The U.S. Food and Drug Administration approved a new blood test this week to determine which patients need a CAT scan for further evaluation if there is a suspected mild traumatic brain injury or concussion.
While this may not seem like a big deal, about 2.8 million people with TBIs ended up in Emergency Rooms in 2013, according to the most recent data from the Centers for Disease Control and Prevention. Many get CAT scans, a brain imaging study, to see how serious the injury is and all those CAT are bad for many reasons:
What does this test, called the Banyan Brain Trauma Indicator, actually do? It detects proteins in the blood caused by actual destruction of brain tissue. It predicts which CAT scan will show brain damage and which will not with amazing accuracy. If the test is positive, 97.5 percent of brain CAT scans will show damage and if it is negative, 99.6 percent of these imaging studies will be negative.
There are limitations at this time. It has only been approved for adults, we do not know the cost yet, and the testing all has to be done within 12 hours of the injury which is not always possible. But the initial FDA testing on almost 2,000 individuals suspected to have a concussion were completed in a timely manner. They looked at blood samples from adults with suspected concussion and reviewed the product's performance by comparing concussion blood tests results with CT scan results.
"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, M.D., director of the FDA's Center for Devices and Radiological Health in a statement. The FDA worked closely with the Defense Department on the application since it was seeking a diagnostic tool to evaluate solders in combat zones. The Pentagon had funded the testing which led to the FDA approval, according to a New York Times article.