The FDA cleared the first blood test to evaluate mild traumatic brain injury in adults. According to the FDA, the Banyan Brain Trauma Indicator will help physicians determine if patients suspected of having mTBI need CT scans, which will help prevent unnecessary neuroimaging and associated radiation exposure to patients.
Here are six insights:
1. The Brain Trauma Indicator measures levels of ubiquitin C-terminal hydrolase and glial fibrillary acidic protein, two proteins released from the brain into the blood and measured within 12 hours of head injury.
2. In a prospective study of 1,947 individual blood samples from adults suspected of having mTBI, the Brain Trauma Indicator was able to predict the presence of intracranial lesions on CT scans 97.5 percent of the time and the absence of intracranial lesions on CT 99.6 percent of the time.
3. The findings indicate that the test can reliably predict the absence of intracranial lesions. Healthcare providers 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.
4. The 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. "Availability of a blood test for mTBI/concussion will likely reduce the CT scans performed on patients with concussion each year, potentially saving our healthcare system the cost of often unnecessary neuroimaging tests."
5. There were roughly 2.8 million TBI-related ED visits, hospitalizations and deaths in the U.S. in 2013, according to the CDC.
6. The FDA reviewed the Brain Trauma Indicator in less than six months through its breakthrough devices pathway, the De Novo premarket review pathway, a regulatory pathway for novel low- to moderate-risk devices for which there is no prior legally marketed device.
"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," said Jeffery Shuren, MD, director of the FDA's Center for Devices and Radiological Health.
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