February 14, 2018
The US Food and Drug Administration (FDA) has cleared the first blood test to evaluate mild traumatic brain injury (mTBI) in adults.
The Banyan Brain Trauma Indicator (Banyan Biomarkers Inc) will help physicians determine the need for computed tomography (CT) in patients suspected of having mTBI and help prevent unnecessary neuroimaging and associated radiation exposure to patients, the agency said.
The Brain Trauma Indicator measures levels of two proteins — ubiquitin C-terminal hydrolase and glial fibrillary acidic protein — that are released from the brain into blood and measured within 12 hours of head injury.
In a large prospective study of 1947 individual blood samples from adults suspected of having mTBI/concussion, the Brain Trauma Indicator was able to predict the presence of intracranial lesions on CT 97.5% of the time and the absence of intracranial lesions on CT 99.6% 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," the FDA said in a statement.
This approval "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, MD.
"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. 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," added Gottlieb.
In 2013, there were roughly 2.8 million TBI-related emergency department visits, hospitalizations, and deaths in the United States, according to the Centers for Disease Control and Prevention.
"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, MD, director of the FDA's Center for Devices and Radiological Health.
"The FDA's review team worked closely with the test developer and the US Department of Defense to expedite a blood test for the evaluation of mTBI that can be used both in the continental US as well as foreign US laboratories that service the American military," he added.
The FDA reviewed and authorized the Brain Trauma Indicator in less than 6 months through its breakthrough devices pathway. This pathway is intended to help patients have more timely access to devices and breakthrough technologies that provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases, for which no approved or cleared treatment exists, or that offer significant advantages over existing approved or cleared alternatives.