The Food and Drug Administration (FDA) just approved a blood test to evaluate and diagnose concussions, the first of its kind. This new kind of testing is quick and may reduce reliance on CT scans which can expose patients to radiation.
Concussions are a serious issue in work-related injuries and incidents, particularly in athletic jobs but also for workers concerned with struck-by or falling hazards. They are compensable but can sometimes be difficult to diagnose or screen, and current screening methods like CT scans elicit worries about radiation.
When a patient is suspected of having a mild traumatic brain injury (mTBI), also called a concussion, they are examined using a 15-point Glasgow Coma Scale first, then they may undergo a CT scan to detect tissue damage (intracranial lesions) which may need further treatment. CT scans do not always detect these lesions in patients who undergo testing, and patients and physicians worry about unnecessary radiation exposure. The new Banyan Brain Trauma Indicator may make it easier on physicians to decide whether a subsequent CT scan is worthwhile or not. It can identify two proteins that appear in the blood within 12 hours after a brain injury. Levels of the two proteins may predict which patients have brain lesions that would be visible in a CT scan, and which ones won’t. Currently the test can give results in three-four hours, but the chairman and CEO of Banyan Biomarkers Henry L. Nordhoff told The New York Times that his company and the Defense Department are working together to make results available in under an hour.
The FDA Commissioner Scott Gottlieb, M.D. said that a having a blood test option for concussion scans could reduce the number of CT scans performed on patients, saving money on unnecessary testing. The Centers for Disease Control and Prevention (CDC) reported approximately 2.8 million TBI-related ER visits, hospitalizations, and deaths in 2013. About three-quarters of TBIs that occur are assessed as mTBIs or concussions, but most patients with concussion symptoms have negative CT scans.
The deliberations to approve the blood test took less than six months, and were part of the administration’s “Breakthrough Devices Program” which serves to expedite breakthrough devices and technologies so that patients have quicker access to treatments that offer significant advantages over existing treatments.

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