FDA approves new blood test to detect concussions

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The Food and Drug Administration approved a first-ever blood test to detect the telltale signs of serious brain injury, on Wednesday, Feb. 14, 2018.

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:

  • About 90 percent or more of these CAT scans are negative and are at a minimum of $2,000 each which includes including doctors’ fees. That is over 2 billion dollars in unnecessary spending every year.
  • Head CAT scans expose each patient to the radiation equivalent to 21 chest x-rays. With over a million people or more getting them for TBIs, they cause an increase in the possibility of subsequent cancer in these patients, especially in children.
  • They take a good deal of time to do and this increases the back up in our emergency facilities.

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.

Testing in children is supposed to start later this year, and the test could be used in sports injuries as well. Once we can get a better handle on TBIs, we will be able to prevent more repetitive brain injury while spending less money and cause less harm.