Traumatic brain injuries (TBI) or concussions contributed to about 30% of all injury deaths according to estimates from the Centers for Disease Control and Prevention. As a result, companies are working diligently to develop tests for the detection of TBI and concussions.
Chembio Diagnostics is the latest firm to step into the arena, through a collaboration with Perseus Science Group. The two companies are working to develop a point-of-care diagnostic test for TBI.
“We’re going to put their patented biomarker onto the [DPP] to develop a rapid test for concussion,” John Sperzel, Chembio’s CEO, told MD+DI. “The way the test works is that you stick the fingertip just like you would do for a diabetes test and take about a 10-microliter sample of blood – apply it to our platform, apply an activation biological and you get a result in 15 to 20 minutes.”
The terms call for Chembio to receive funding from Perseus, subject to satisfying certain milestones, to advance the development of the test. This agreement builds on previous agreements between the two firms that resulted in the completion of technical feasibility to detect Perseus’ patented biomarker.
“We completed that feasibility and this latest agreement is to move into the development stage,” Sperzel said.
Chembio said that it would have to get a nod from FDA before it could market the test. If the test could clear regulatory hurdles then it would give Chembio and Perseus an opportunity to compete against Banyan Biomarkers, a firm that received a de novo request from FDA for a blood-based detection platform for concussion.
“The platform that [Banyan Biomarkers] has is an ELISA-based laboratory platform,” he said. “They have licensed that platform to Biomérieux, who’s going to put it on a lab platform. They’ve licensed it to Abbott who hopes to put it on their iStat platform. We hope to be the first to bring a fingerstick point-of-care device to the market.”
Outside of Banyan Biomarkers approach, current methods for diagnosing TBI include neurological examination, cognitive testing, and imaging tests such as CT scan, MRI, and PET scans.
“That’s a pretty expensive way and frankly not a definitive way to either rule in or rule out, [TBI] or concussions,” he said. “We think this could be a significant … test in the overall assessment of [TBI].”