Concussion detection tech scores milestone with FDA clearance for brain injury diagnostic

Banyan Biomarkers’ blood test is designed to spot the presence of two protein biomarkers associated with mild brain injury — UCH-L1 and GFAP.

The interest in developing ways to rapidly diagnose a concussion to reduce the need for CT scans has given rise to a number of companies that have taken different approaches to this challenge from eye tests to diagnostics and sideline assessments for athletes. A blood test by Banyan Biomarkers to spot the presence of two protein biomarkers associated with mild brain injury — UCH-L1 and GFAP — has been granted marketing authorization by the U.S. Food and Drug Administration. 

Banyan Biomarkers’ Banyan BTI test was cleared as part of the FDA’s Breakthrough Devices Program. The program’s goal is to speed up the review of innovative breakthrough technologies.  The FDA approval was based on prospective, multi-center pivotal study called ALERT-TBI. It enrolled 2,011 patients at 24 independent clinical sites in the U.S. and EU and compared the test’s results to head CT scans of patients who came to ERs with a suspected head injury. The study showed that Banyan BTI achieved high sensitivity and high negative predictive value for ruling out the need for a head CT scan and provides objective data for healthcare providers to aid in the evaluation of patients with suspected traumatic brain injury or TBI, according to a company news release.

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The FDA clearance for Banyan’s blood test is a milestone for concussion diagnostics. Many different companies have also worked towards this goal. Last year Abbott received an $11.2 million contract from the U.S. Department of Defense (DOD) to develop a portable blood assay to detect mild traumatic brain injury, a contract that builds on a previous agreement, inked in 2014. The foundation for Abbott’s test is the medical device company’s portable i-STAT technology, which is currently being used in hospitals to support cardiovascular and prenatal care and provide other simple blood tests.

Third Eye Diagnostics is developing a noninvasive, handheld device to make the process of assessing intracranial pressure for the severity of traumatic brain injury and hydrocephalus easier and faster.

In 2014, Banyan Biomarkers was one of five companies GE and the NFL funded through the Head Health Challenge to identify and support screening tools and detection devices to speed up diagnosis and improve treatment for traumatic brain injury. Others included BrainScope Company, which developed a device using EEG technology to help medics identify TBI, Quanterix which was exploring singular molecule array technology to develop and validate blood biomarkers to help physicians better predict long-term prognosis for TBI patients.

Another company, Sway Medical, received 510K clearance for a mobile screening tool for athletes to test their balance after a potentially dangerous hit. A few businesses are developing eye tracking tests as a way to detect concussions such as RightEyeOculogica, and SyncThink.

Photo: jxfzsy, Getty Images