FDA approves blood test that promises to diagnose brain trauma

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The US Food and Drug Administration has approved a new blood test that could help diagnose concussions without the need for X-rays. According to the FDA, the test can speed up treatment and potentially save money.

However, experts say the blood test isn’t quite what people are promising.

Billed as a “blood test for concussion”, the new test is actually incapable of identifying an isolated brain injury. Instead, it tests for two distinct proteins that can leak from brain cells into the bloodstream after a head injury. The presence of these proteins acts as a sign of bleeding in the brain or other complications from brain trauma, rather than the trauma itself.

Currently, X-ray or CT scans are required to identify bleeding in the brain after a concussion. This can take valuable time and expose healthy individuals to unnecessary radiation.

With the new test, health professionals still have to confirm the findings using scans, but individuals without the proteins in their blood can safely avoid excessive scans and radiation. However, the results can take up to 12 hours – an excruciatingly long time for an injury where minutes can mean the difference between health and lifelong disability or death.

FDA Commissioner Dr. Scott Gottlieb said the test fits with the agency’s goals for delivering new technologies to patients and reducing unnecessary radiation exposure.

The test “sets the stage for a more modernized standard of care for testing of suspected cases,” Gottlieb said in a statement.

While this may be a sign of progress, some say the test is overpromising on what it can actually achieve.

Dr. Walter Koroshetz, director of the National Institute of Neurological Disorders and Stroke, warns the test isn’t sensitive enough to accurately diagnose a concussion.

“This may be a beginning. It’s not the pot of gold at the end of the rainbow,” Koroshetz said.

The new approval of this blood test shows that researchers are working towards a comprehensive way to objectively identify a concussion, but it will take more time and research to refine the process to provide that level of clarity.

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