The FDA has approved the first blood test for mild traumatic brain injury (mTBI), an in vitro diagnostic developed by Banyan Biomarkers to identify patients with suspected concussions.
Banyan BTI™ is designed to identify two brain-specific protein biomarkers—Ubiquitin Carboxy-terminal Hydrolase-L1 or UCH-L1 and glial fibrilliary acidic protein (GFAP)—that rapidly appear in the blood after a brain injury in patients with suspected mTBI, and can be and measured within 12 hours of head injury.
Test results can be available within 3 to 4 hours.
Banyan BTI—“BTI” stands for Brain Trauma Indicator—was approved following a study that identified patients with head trauma who could safely forego the need for a CT scan. The prospective multi-center pivotal study, ALERT-TBI, enrolled 2,011 patients at 24 independent clinical sites in the U.S. and E.U., and compared the test's results to head CT scans of patients presenting to emergency departments with suspected head injury.
The study showed that Banyan BTI was able to predict the presence of intracranial lesions on a CT scan 97.5% of the time, and those who did not have intracranial lesions on a CT scan 99.6% of the time—showing high sensitivity and high negative predictive value for ruling out the need for a head CT scan, according to Banyan.
Banyan added that it is engaged in additional studies to determine if the biomarkers have applications in monitoring recovery after injury, as well as in other degenerative conditions of the brain.
“With extensive clinical research and scientific validation, Banyan BTI has shown that these two specific protein biomarkers, which are released from the brain and circulate in the blood after a brain injury, can provide objective data to healthcare providers when evaluating patients with a traumatic brain injury,” Banyan Biomarkers Chairman and CEO Henry L. Nordhoff said in a statement. “Receiving marketing authorization from the FDA for the first blood test for TBI is a significant milestone that will transform how brain injury is managed.”
Banyan BTI was reviewed and authorized in less than 6 months by the FDA under its Breakthrough Devices Program. The program is intended to facilitate development of innovative technologies by accelerating agency reviews.
In granting Banyan’s De Novo premarket review pathway request for Banyan BTI, the FDA also created a classification regulation for devices of the type, allowing the diagnostic to serve as a predicate device.
‘More Modernized Standard of Care’
“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,” added FDA Commissioner Scott Gottlieb, M.D. in a separate statement by the agency. “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.”
Dr. Gottlieb added that the FDA’s approval of Banyan BTI supported the agency’s Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging, designed to ensure that each patient is getting the right imaging exam, at the right time, with the right radiation dose.
Until now, most patients suspected of having head injuries have been examined using 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 intracranial lesions that are detectable after having a CT scan, according to the FDA.
Levels of the blood proteins assessed by Banyan BTI can help predict which patients may have intracranial lesions visible by CT scan and which won’t, the agency added.
The FDA cited U.S. Centers for Disease Control and Prevention statistics recording approximately 2.8 million TBI-related emergency department visits, hospitalizations and deaths in the U.S. in 2013. Of those cases, TBI contributed to the deaths of nearly 50,000 people.
The U.S. Army Medical Research and Materiel Command (USAMRMC) supported development of Banyan BTI under Contract No. W81XWH-10-C-0251.
That contract, and another USAMRMC contract awarded to Banyan (W81XWH-06-1-0517) supported a study detailing the diagnostic ability of the two brain-specific protein biomarkers used by Banyan BTI. “Our data suggest that the diagnostic ability of UCH-L1 may be limited to the early h after mild-to-moderate TBI, whereas rising serum GFAP concentrations over the initial 24 [hour] post-injury were associated with a positive head CT,” researchers concluded in Journal of Neurotrauma, published by Clinical OMICs publisher Mary Ann Liebert Inc.
Last month, USAMRMC indicated that an even faster assay is under consideration, saying it intends to modify the contract “to develop a less than 1 hour UCH-L1/GFAP Assay on a self-contained bench top device that has minimal associated equipment and reduces the logistical burden in military operations.”
“This assay will provide a remarkable capability for the way we evaluate and care for our service members with TBI,” added Lt. Col. Kara Schmid, project manager for the Neurotrauma and Psychological Health Project Management Office for the U.S. Army Medical Materiel Development Activity, whose mission is to “develop and deliver quality medical capabilities to protect, treat, and sustain the health of our service members.”