A first-ever test from San Diego’s Banyan Biomarkers to help doctors diagnose traumatic brain injuries has won Federal Drug Administration approval.
The privately held company anticipates the test will reduce the number of CT scans ordered on patients for a possible concussion, lowering costs and radiation exposure. More than 90 percent of patients posting up at the emergency department with mild concussion symptoms receive a negative CT scan.
Banyan’s test identifies two brain-specific biomarkers that rapidly appear in the blood after a brain injury, helping assess whether a patient has a concussion. The FDA’s approval cleared the way for the company to market its Brain Trauma Indicator.
“Brain biomarkers will change the practice of emergency care for mild TBI (traumatic brain injury) and will greatly assist a large number of patients. The impact will be improved medical care by reducing radiation exposure to the patient and improving efficiency in the emergency department,” said in a news release Andy Jagoda, professor and chair in the Department of Emergency Medicine at the Icahn School of Medicine at Mount Sinai.
The FDA reviewed the test under the Breakthrough Devices Program, intended to facilitate the development and expedite the review of innovative technologies.