FDA approves first blood test to evaluate concussions in adults
Medical providers will have a new tool to diagnose concussions since as the U.S. Food and Drug Administration today permitted marketing of the first blood test to evaluate mild traumatic brain injury (mTBI), commonly called a concussion, in adults. The FDA reviewed and authorized for marketing the Banyan Brain Trauma Indicator in fewer than 6 months as part of its Breakthrough Devices Program. The new quick testing option will help reduce the need for CT scans, radiation exposure, for patients.
Concussions are compensable in work-related claims, but have been difficult in the past since screening for concussions has been complicated because of concerns of exposure to diagnostic tools that emit radiation. Now wide spreading initial screening will be available to athletes who have suffered concussions in training and participating in competitive events, ie. Football players (see “$1 Billion Settlement Affirmed - NFL Retired Players Concussion Class Action.”
Workers’ Compensation benefits have been available to workers to have suffered concussions in their employment. “Where an employee was struck in the head by a wrecking bar and suffered a concussion, the employee was permitted to adjudicate a claim for medical benefits prior to a final determination concerning the fixing of permanency. Voorhees v. Glenwal Co., 77 N.J.Super. 65, 185 A.2d 401 (App.Div.1962).” Gelman, Jon L, Workers Compensation Law, 38 NJPRAC 12.4 (Thomson-Reuters 2018).
Most patients with a suspected head injury are examined using a neurological scale, called the 15-point Glasgow Coma Scale, followed by a computed tomography or CT scan of the head to detect brain tissue damage, or intracranial lesions, that may require treatment; however, most patients evaluated for mTBI/concussion do not have detectable intracranial lesions after having a CT scan. Availability of a blood test for concussion will help healthcare 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. Today’s action supports the FDA’s Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging—an effort to ensure that each patient is getting the right imaging exam, at the right time, with the right radiation dose,” said FDA Commissioner Scott Gottlieb, M.D. “A blood-testing option for the evaluation of mTBI/concussion not only provides healthcare professionals with a new tool but also sets the stage for a more modernized standard of care for testing of suspected cases. In addition, 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.”
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. Most 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 Jeffrey Shuren, M.D., 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 the 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. Predicting if patients have a low probability of intracranial lesions can help healthcare 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 predicted 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 healthcare 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 suspected of having mTBI.
The Brain Trauma Indicator was reviewed under the FDA’s De Novo premarket review pathway, a regulatory pathway for some low- to moderate-risk devices that are novel and for which there is no prior legally marketed device.
The FDA is permitting marketing of the Brain Trauma Indicator to Banyan Biomarkers, Inc.
Jon L. Gelman of Wayne NJ is the author of NJ Workers’ Compensation Law (West-Thomson-Reuters) and co-author of the national treatise, Modern Workers’ Compensation Law (West-Thomson-Reuters).