Banyan Biomarkers, a Little Dog client based in San Diego, has been granted a De Novo request from the FDA for the commercialization of Banyan BTI (Brain Trauma Indicator), the first-ever blood test approved to help evaluate patients with suspected traumatic brain injury (concussion).
The new blood test comes at a crucial time, as emergency room visits are increasing likely due to better awareness of concussions. As FDA Commissioner Scott Gottlieb told U.S. News and World Report:
“A blood-testing option for the evaluation of mTBI [mild traumatic brain injury]/concussion not only provides health care professionals with a new tool, but also sets the stage for a more modernized standard of care for testing of suspected cases,” said Gottlieb.
The news received coverage in major outlets, including:
- The Associated Press: First blood test to help diagnose brain injuries gets US OK
- The New York Times: Concussions can be detected with new blood test approved by the FDA
- NBC News: FDA approves new blood test to detect concussions
- Wall Street Journal: Concussion Blood Test Wins FDA Approval
- Xconomy: FDA OKs Banyan Diagnostic, the First Blood Test for Concussions
More information:
- Banyan Biomarkers press release: https://www.businesswire.com/news/home/20180214006251/en
- FDA news release: https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm596531.htm