FDA Greenlights Marketing of First Blood Test Designed to Aid in Diagnosis and Evaluation of Concussions

CMS, Medicare, Medicare Set-Aside Blog, MSP News on February 15, 2018
Posted by Erin O'Neill, PA-C, JD

On February 14, 2018, the Food and Drug Administration (FDA) announced authorization of marketing of the Banyan Brain Trauma Indicator, which is the first blood test of its kind designed to aid in the evaluation of mild traumatic brain injuries (concussions) in adults. The blood test is designed to detect the presence of two protein biomarkers, UCH-L1 and GFAP, which appear in the blood of an individual who has sustained a traumatic brain injury. Results from testing can be used to determine which patients are not likely to have findings on a CT scan, thereby eliminating radiation exposure and expense associated with unnecessary testing.

Work-related traumatic brain injuries are not uncommon and can represent some of the most complex workers’ compensation claims to manage. Even mild traumatic brain injuries can result in serious and long-term consequences. The type of testing described above is also being evaluated by additional studies to determine if it can be used to monitor recovery following traumatic brain injury. Blood tests like the Banyan Brain Trauma Indicator will hopefully become standard of care for evaluation of all traumatic brain injuries and lead to additional advances in the diagnosis and treatment of concussion and post-concussion syndrome. Additional information regarding the FDA News Release can be found here: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm596531.htm