FDA approves Banyan Biomarkers’ traumatic brain injury blood test

In February, the U.S. Food and Drug Administration cleared UF spinoff Banyan Biomarkers to begin marketing the first blood test to evaluate mild traumatic brain injury (mTBI), or concussion, in adults.

Banyan Biomarkers Chief Science Officer Ronald Hayes is a former researcher at UF’s McKnight Brain Institute who founded the company in the university’s Sid Martin Biotech Incubator in Alachua. Much of the early funding for Hayes’ research came from the U.S. Department of Defense, which is looking for better ways of diagnosing TBI among soldiers.

“It’s a silent epidemic,” Hayes said of TBI in a 2009 Explore magazine article. “This research is where homeland defense provides a service for the soccer mom.”

Most patients with a suspected head injury are examined using a 15-point neurological test and a CT scan to detect brain tissue damage, the FDA said in its release. However, a majority of patients evaluated for mTBI/concussion do not have detectable tissue damage. Availability of a blood test for concussion will help health care professionals determine the need for a CT scan in patients suspected of having mTBI and help prevent unnecessary neuroimaging and associated radiation exposure to patients.

“Helping to deliver innovative testing technologies that minimize health impacts to patients while still providing accurate and reliable results to inform appropriate evaluation and treatment is an FDA priority,” said FDA Commissioner Dr. Scott Gottlieb. “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.”

According to the U.S. Centers for Disease Control and Prevention, in 2013 there were approximately 2.8 million TBI-related emergency department visits, hospitalizations and deaths in the U.S. Of these cases, TBI contributed to the deaths of nearly 50,000 people. TBI is caused by a bump, blow or jolt to the head or a penetrating head injury that disrupts the brain’s normal functioning. Its severity may range from mild to severe, with 75 percent of TBIs that occur each year being assessed as mTBIs or concussions. A majority of patients with concussion symptoms have a negative CT scan. Potential effects of TBI can include impaired thinking or memory, movement, sensation or emotional functioning.

“A blood test to aid in concussion evaluation is an important tool for the American public and for our service members abroad who need access to quick and accurate tests,” said Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health. “The FDA’s review team worked closely with the test developer and the U.S. Department of Defense to expedite a blood test for the evaluation of mTBI that can be used both in the continental U.S. as well as foreign U.S. laboratories that service the American military.”

The Brain Trauma Indicator works by measuring levels of proteins, known as UCH-L1 and GFAP, that are released from the brain into blood and measured within 12 hours of head injury. Levels of these blood proteins after mTBI/concussion can help predict which patients may have intracranial lesions visible by CT scan and which won’t. Being able to predict if patients have a low probability of intracranial lesions can help health care professionals in their management of patients and the decision to perform a CT scan. Test results can be available within 3 to 4 hours.

The FDA evaluated data from a multi-center, prospective clinical study of 1,947 individual blood samples from adults with suspected mTBI/concussion and reviewed the product’s performance by comparing mTBI/concussion blood tests results with CT scan results. The Brain Trauma Indicator was able to predict the presence of intracranial lesions on a CT scan 97.5 percent of the time and those who did not have intracranial lesions on a CT scan 99.6 percent of the time. These findings indicate that the test can reliably predict the absence of intracranial lesions and that health care professionals can incorporate this tool into the standard of care for patients to rule out the need for a CT scan in at least one-third of patients who are suspected of having mTBI.