The Food and Drug Administration approved a new blood test on Feb. 14 – the Banyan Brain Trauma Indicator – for assessing patients with mild traumatic brain injuries, also known as concussions.
Most traumatic brain injuries are classified as “mild,” and the majority of patients have negative CT scans, according to an FDA announcement. Within a matter of hour, this test can help predict which patients will have negative scans by measuring certain proteins released by brain tissue, thereby potentially eliminating unnecessary imaging – and the costs and radiation exposure that would go along with it.
The review and authorization process for the test took less than six months because it went through the FDA’s Breakthrough Devices Program. The FDA evaluated data from a multicenter, prospective clinical trial that compared patients’ blood test results with their CT scans and showed that the test was able to detect an absence of intracranial lesions 99.6% of the time.