FDA Gives OK on Blood Test that Can Detect Traumatic Brain Injury

The past few years has seen quite a bit of research and discussion over concussions, particularly in traumatic brain injuries in related to concussions found in professional football players. This week, that research has culminated in a new blood test aimed at detecting mild traumatic brain injury (mTBI; or, commonly, “concussion”) to help diagnose and treat them more quickly and effectively.

The United States Food and Drug Administration has just given marketing authorization to the private biotech Banyan Biomarkers for the Bayan Brain Trauma Indicator. This piece of biotechnology can help doctors not only diagnose brain injuries, but also whether or not a person suffering a concussion needs a computed tomography (CT scan) in order to more accurately detect brain tissue damage.

A patient who has a suspected head injury is typically assessed using a neurological scale—called the 15-point Glasgow Coma Scale—and then followed up with a CT scan of the head to look for intracranial lesions that might require any type of treatment. Alas, most patients evaluated for mTBI do not have easily detectable intracranial lesions, even after the CT scan.

Thus, a blood test that can identify a concussion will further assist health care professionals to determine increased need for CT scans. More importantly, perhaps, this could help to prevent unnecessary neuroimaging—and its associated radiation exposure—to many patients.

FDA Commissioner Scott Gottlieb, MD, comments, “Helping to deliver innovative testing technologies that minimize health impacts to patients while still providing accurate and reliable results to inform appropriate evaluation and treatment is an FDA priority.

Today’s action supports the FDA’s Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging—an effort to ensure that each patient is getting the right imaging exam, at the right time, with the right radiation dose. A blood-testing option for the evaluation of mTBI/concussion not only provides health care professionals with a new tool, but also sets the stage for a more modernized standard of care for testing of suspected cases.

In addition, availability of a blood test for mTBI/concussion will likely reduce the CT scans performed on patients with concussion each year, potentially saving our health care system the cost of often unnecessary neuroimaging tests.”

The Brain Trauma Indicator works by measuring the levels of certain proteins in the blood, which have been released into the bloodstream within the first 12 hours of injury. These are UCH-L1 and GFAP.

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