By Benjamin Ross
March 21, 2018 | The US Food and Drug Administration (FDA) has granted the De Novo request for the commercialization of Banyan BTI (Brain Trauma Indicator), an in vitro diagnostic blood test to aid in the evaluation of adult patients with suspected traumatic brain injury (TBI).
The Centers for Disease Control and Prevention (CDC) report that TBIs are contributing factors to 30% of all injury-related deaths in the US.
The FDA reviewed the test in fewer than six months under the Breakthrough Devices Program, which is intended to facilitate the development and expedite the review of innovative breakthrough technologies.
Banyan was careful to emphasize that the test cannot diagnose anything, only a doctor can do that. But the company believes that the Banyan BTI will be useful and is working to make it more widely available.
“At this time, the Banyan BTI can be done in a clinical laboratory, though Banyan is now working with its commercial partners to make the test available in hospitals and emergency departments,” a Banyan spokesperson told Diagnostics World via email. “Banyan is also looking at different ways to make the test available more broadly, for example, using the test on a handheld device.”
Alex Diamond, Director of the Program for Injury Prevention in Youth Sports and Assistant Professor of Orthopedics and Rehabilitation at Vanderbilt University Medical Center has been aware of the test since its authorization and been following it closely. While some reports have posited the test as the definitive test for concussion diagnoses, Diamond contests that.
“The way this blood test has been portrayed is misleading,” Diamond told Diagnostics World. “It cannot diagnose concussions. What it’s looking for, as a blood test, are proteins that are released by blood after an injury in the brain. Typically, concussions are not associated with bleeding in the brain.”
According to the FDA’s authorization letter, Banyan BTI identifies measurements of glial fibrillary acidic protein (GFAP) and ubiquitin Cterminal hydrolase-L1 (UCH-L1) proteins in blood samples. The Agency has labeled the blood test as a “brain trauma assessment test,” saying it is a device that consists of reagents used to detect and measure brain injury biomarkers in human specimens.
Diamond sees the clinical value of the test in determining whether a patient has a TBI prior to receiving a CT scan.
“Trying to determine who needs a CT scan and who doesn’t is the age-old question,” says Diamond. “Obviously with the radiation associated with CT scans, we’re trying to order less and less of them, and even in the age of medicine that we’re in now we want to order tests when an issue is truly indicated and not raise healthcare costs unnecessarily.”
Banyan’s BTI can limit the amount of CT scans requested by 30%, Kevin Hrusovsky, CEO of Quanterix (a distribution partner of Banyan), tells Diagnostics World. He says the challenge there is that this current test only shows that GFAP or UCH-L1 is present. If neither of those 2 markers are present, myriad possibilities still stand.
“The future of where a lot of this technology is going to go is not just ruling out the CT scan, which really only says the brain isn’t bleeding, but in advancing these 2 markers so that they can start to see them in healthy people and any gradient from health and what might be the reasons for that,” Hrusovsky says.
The implications for the FDA’s authorization of Banyan’s blood test extend beyond the test itself, Hrusovsky says. “It’s a breakthrough to have the FDA finally sanction that a blood biomarker can play a role in an FDA-approved test. That milestone triggers a lot more enthusiasm and investment interest in the possibilities of migrating to areas of [greater value]... It’s game changing for opening the flood gates to measure brain health with minimally invasive blood tests.”
Diamond is more reserved when discussing the test’s implications, instead focusing on the opportunity the test gives to educate people about TBIs and improving research.
“[Right now] we really have to rely on the history and physical [of a patient], and trust that they report their symptoms to us,” says Diamond. “Hopefully more questions will bring us more answers later down the road.”
Hrusovsky looks ahead to the trajectory of precision health. “Now that we’ve got these tools [like Banyan’s BTI test], let’s make sure the world knows about them so we can change the way health is practiced from reactive sick care, not really getting any kind of attention until you’re sick, to proactive and personalized prevention of disease.”