|Ahead 200--Courtesy of BrainScope|
Research is advancing rapidly to validate imaging and blood biomarkers that can easily identify concussions and other traumatic brain injuries on the battlefield, in the sports arena and in emergency care rooms. The FDA demonstrated that the issue is a top priority for it by setting up a public meeting on March 3 to address the scientific developments, regulatory challenges as well as big data standardization, sharing and analysis issues raised by the hunt for TBI biomarkers.
The meeting will be dominated by commentary from physicians, scientists and regulators working in the field. The sole industry representatives are slated to be Luca Marinelli, who is the program manager from healthcare commercial partnerships for the GE Global Research Center, and Ronald Hayes, the founder and president of Banyan Biomarkers.
Imaging giant GE is in a four-year partnership since March 2013 with the National Football League that's backed by $60 million and a mission to develop technologies to better discover, treat and prevent traumatic brain injury (TBI). Most recently, the pair doled out $10 million last July across 6 research projects including three for startups: San Diego, CA-based Banyan Biomarkers, Bethesda, MD-based BrainScope and Lexington, MA-based Quanterix.
|Minicare system--Courtesy of Philips|
Banyan partnered with Royal Philips ($PHG) in January to develop a blood biomarker test for Philips' hand-held Minicare I-20 system that detects two protein biomarkers, ubiquitin c-terminal hydrolase-L 1 (UCH-L1) and glial fibrillary acidic protein (GFAP). It's starting a 2,000 patient pivotal trial of the test for which it expects results this year. Banyan is also working closely with Quanterix; the latter debuted a biomarker TBI test earlier this month at an NFL event.
For its part, BrainScope last May got a next-gen version of its head-worn EEG device, Ahead 200, that works with a smartphone to read and analyze the data cleared by FDA. That follows the original FDA clearance for an earlier iteration of the system in 2014.
The FDA has been largely hands-off on the regulation of diagnostic laboratory-developed tests (LDTs) but it has promised to get much more involved this year with a new approval pathway and an expansion of its purview over them. There is an entire panel at the March FDA TBI meeting devoted to regulatory issues, with presentations from various representatives of the Center for Devices and Radiological Health (CDRH).
The Department of Veterans Affairs and the U.S. Army also will have speakers at the TBI meeting; the VA and the U.S. Department of Defense (DOD) are heavily involved in backing research in the field--having given grants to companies including Banyan Biomarkers and BrainScope.
Obama's nominee to head the FDA, Dr. Robert Califf, will kick off the meeting. The agency defined the mission of the meeting as "to obtain input on the scientific, clinical, patient and regulatory considerations associated with TBI biomarker development to improve diagnosis and clinical utility for TBI."
- here is the FDA meeting announcement