The FDA today announced plans for a workshop to discuss the development of technologies for detecting biomarkers related to traumatic brain injuries.
The aim of the workshop is to discuss both the challenges and solutions related to biomarker development methodologies, the FDA said. During the meeting, the agency will seek to establish strategies for standardizing data and sharing analysis of big data sets related to traumatic brain injury.
The federal watchdog said it hopes to obtain input on scientific, clinical, patient and regulatory considerations related to TBI biomarker development.
The meeting will take place March 3 at its White Oak Campus in Silver Springs, according to an FDA press release. A webcast of the meeting will also be made available, the agency said.
Royal Philips (NYSE:PHG) and BioDirection have said they are developing blood tests to identify traumatic brain injuries, including concussions, based on biomarker technologies.
Philips and blood test developer Banyan Biomarkers said in January they inked a deal to develop and commercialize a handheld blood test to test for concussions. Financial terms of the agreement were not disclosed.
The new test will be based on Philips’ Minicare I-20 system, and will useable at the point of care, the companies said. The I-20 system consists of a handheld analyzer and software and a single use, disposable cartridge for the test.
Currently there are no blood tests usable by physicians at the point of care to detect the presence and severity of brain trauma, Philips said, though Banyan Biomarkers has identified 2 proteins that rapidly appear in the blood of patients after injury.
BioDirection is also tilting at a rapid point-of-care concussion test with its Tbit. Last week, the company raised $4 million in a Series B convertible preferred stock financing round to support its Tbit.
The Tbit blood test is designed to detect and measure protein biomarkers released from the brain following head trauma to identify concussions and traumatic brain injuries in less than 90 seconds, the Boston, Mass.-based company said.
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