FDA on Wednesday approved the first blood test to help diagnose mild traumatic brain injuries (mTBI), commonly known as concussions, in adults.
CDC data show in 2013 TBI was associated with about 2.8 million U.S. emergency department visits, hospitalizations, and deaths. According to FDA, TBI can result from a jolt to the head, a bump, or a penetrating head injury that interrupts the brain's normal function. A TBI's severity can range from mild to severe, with potential effects including impaired emotional functioning, memory, movement, sensation, or thinking—though the majority of TBI cases each year are considered mild concussions.
Health care providers examine most individuals who have a suspected head injury using a neurological scale, called the 15-point Glasgow Coma Scale, and a CT scan to detect brain tissue damage or intracranial lesions. However, a majority of individuals who are assessed for concussions do not have detectable intracranial lesions.
About the blood test
Banyan Biomarkers' Brain Trauma Indicator is intended to support providers conducting head injury exams and reduce the use of unnecessary neuroimaging and associated radiation exposure. The blood test measures the levels of two proteins—called ubiquitin C-terminal hydrolase and glial fibrilliary acidic protein—that the brain releases into the bloodstream within 12 hours of a head injury.
In a multi-center, perspective clinical trial involving 1,947 individual blood samples from adults who had a suspected concussion, the blood test was 97.5% effective at predicting the presence of intracranial lesions on a CT scan and 99.6% effective at predicting when intracranial lesions would not appear on a CT scan. According to FDA, the blood test can provide those results within three to four hours.
FDA said the findings indicate that the blood test can reliably predict the absence or presence of intracranial lesions, which means providers can use the blood test as part of their standard of care to determine whether a CT scan is needed and cut CT use in at least a third of cases.
FDA approved the blood test for marketing in fewer than six months under the agency's new Breakthrough Devices program, which was created under the 21st Century Cures Act. An FDA spokesperson said the agency worked on the application with the Department of Defense (DOD), which has wanted a diagnostic tool to evaluate soldiers, the Los Angeles Times' "Science Now" reports.
FDA Commissioner Scott Gottlieb said, "A blood-testing option for the evaluation of mTBI/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." He added that the "availability of a blood test for mTBI/concussion will likely reduce the CT scans performed on patients with concussion each year, potentially saving our health care system the cost of often unnecessary neuroimaging tests."
Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health, said, "A blood test to aid in concussion evaluation is an important tool for the American public and for our servicemembers abroad who need access to quick and accurate tests."
Henry Nordhoff, chair and CEO of Banyan Biomarkers, said the company and DOD are working together to shorten the time in which the Brain Trauma Indicator's results are available. Nordhoff said the company is teaming up with two other companies to make the test smaller and faster. He said he expects the test to become available for rapid use in ambulances, athletic training, and emergency departments within two years. Nordhoff also said the company is "planning to do another study in adolescents" to see whether the blood test works in a younger population (Tanner, AP/Sacramento Bee, 2/14; Healy, "Science Now," Los Angeles Times, 2/14; Kaplan/Belson, New York Times, 2/14; FDA release, 2/14).
Caring for concussion patients
According to the CDC, approximately 1.3 million people sustain a form of concussion each year, while many more go unreported. Recently, concussions have received a sharp increase in national exposure. Multiple professional sports leagues, notably the NFL, are working to protect athletes in the wake of a number of deaths and lawsuits concerning afflicted high-profile athletes.
This research brief profiles four concussion management programs to deliver best in-class tips on how progressive providers are managing concussion care.