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Following FDA's OK on Concussion Test, Banyan Biomarkers to Collaborate on Test Adoption


NEW YORK (360Dx) – While last week's thumbs-up from the US Food and Drug marked the first time that a blood-based concussion test could be marketed in the US, Banyan Biomarkers said that it could be months before the test is commercially available for clinical use.

The FDA cleared the way for the marketing of Banyan Biomarker's Brain Trauma Indicator test through its de novo process for novel devices. But in an interview, Banyan Biomarkers Chairman and CEO Henry Nordhoff said that the company has no intention of selling a commercial version blood test just yet. That's partly because the off-the-shelf instrument it used to develop the test for FDA review produces a result in about four hours, which is slower than what's generally needed for clinical applications, Nordhoff said.

Still, the firm expects that within about six months, it can reduce the amount of time to receive a clinical result to within an hour, which would make it feasible for military uses, such as diagnosing mTBIs sustained from exposure to improvised explosive devices and combat wounds, Nordhoff added.

The FDA's review team worked with Banyan and the US Department of Defense — a collaborator and customer of the firm, according to Nordhoff — to expedite the evaluation of the blood test for mTBI and enable its use in laboratories that service the American military inside and outside the US.

Nordhoff said that Banyan continues to work with the DoD and has received an award of $100 million from the military in product development funds. Because the FDA cleared the test as part of a clinical trial for military applications, it can only be used for detection with people 18 or older, the age at which people can enter the US military, he said. As a result, in the future, Banyan intends to conduct clinical studies that prove the test's sensitivity in people younger than 18 as well, he noted.

Although the US military could purchase some of its tests, Banyan does not intend to directly market them for clinical use, Nordhoff said. But the company does intend to continue collaborating with IVD companies that have small or point-of-care instruments with placements in the market, he said. Accordingly, the firm has separate collaborations with Abbott and BioMérieux who have plans to develop tests using Banyan's biomarkers.

Abbott is looking to ultimately develop a test panel that would be used as part of the process of care, and multiple markers provided by multiple sources would provide insights to clinicians about concussions. Beth McQuiston, a medical director and neurologist at Abbott, said in an interview that its license agreement with Banyan began in 2014 and that developing a commercial test for commercial use typically takes up to five years.

She added that Abbott expects to pursue regulatory clearances for the test, including FDA clearance, but emphasized that it aims to ultimately develop a diagnostic panel consisting of multiple markers from multiple sources. Further, a commercial in vitro concussion test is usually one component of many inputs and is used with other tests as well as a clinical exam when a clinician performs a diagnosis.

She added that the firm is developing concussion biomarker tests for different types of platforms, including its point-of-care iSTAT system. 

BioMérieux is developing the test for use in the emergency room. In January 2017, the company announced that it had taken an equity stake in Banyan of about $7 million and obtained the rights to commercialize Banyan’s tests worldwide for use in in vitro diagnostics. BioMérieux said at the time that the two companies would continue to explore co-development opportunities in mTBI and critical care.

BioMérieux's VP of Corporate Financing and Business Development Frédéric Sweeney said in an interview that the FDA clearance "is great news for our partner Banyan and for patient care as there is a large unmet medical need in the management of patients suspected of mild traumatic brain injury."

He said that the BioMérieux version of the test is in early stages of development for the company's Vidas immunoassay platform with the aim of offering a "more automated solution to clinicians in emergency rooms." He said that the firm anticipates that it will proceed along a 510(k) clearance pathway, and that the test is important to the firm in the context of investments in "a number of high medical value biomarkers."

Meanwhile, Banyan and Quanterix, a licensee of Banyan's biomarkers for research use, are separately developing assays for adjacent brain-related disorders — including Alzheimer's and chronic traumatic encephalopathy, a degenerative brain disease suspected of being caused by repeated blows to the head.

The FDA's decision to allow marketing of the Brain Trauma Indicator test comes amid increased scrutiny of concussions, and more generally mild traumatic brain injuries. In the FDA's statement last week announcing the decision, FDA Commissioner Scott Gottlieb said that a  blood-testing option for the evaluation of 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."

Citing statistics from the US Centers for Disease Control and Prevention, the FDA said that in 2013 alone, there were about 2.8 million concussion or traumatic brain injury-related emergency department visits, hospitalizations, and deaths in the US. Of these cases, traumatic brain injuries contributed to the deaths of nearly 50,000 people.

Nordhoff said that his firm has demonstrated the ability of its biomarker proteins ubiquitin carboxy-terminal hydrolase-L1 (UCH-L1) and GFAP to provide results with high sensitivity and high positive predictive value compared to the use of CT scans, which are part of standard testing for mild traumatic brain injury (mTBI). 

"What you really want to do in medicine is satisfy an unmet need, and there has been an unmet need for an objective, rapid, inexpensive, and conveniently available test for traumatic brain injury," Nordhoff said.

In reviewing the product, the FDA evaluated data from a multicenter, prospective clinical study of 1,947 individual blood samples from adults with suspected concussion and compared the Banyan product’s performance with CT scan results.

The Brain Trauma Indicator predicted the presence of intracranial lesions on a CT scan 97.5 percent of the time. Nordhoff noted that the test had a 99.6 percent negative predictive value.

"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 who are suspected of having mTBI," the FDA said in a statement.

Levels of the protein biomarkers after a concussion can be used to predict which patients have intracranial lesions visible by CT scan and which don't, the FDA said.

According to Nordhoff, the total available market for mTBI tests may be broader than CDC statistics suggest. Some people may be avoiding getting tests owing to the price of obtaining a CT scan, which can cost from $800 to $1,500, he noted, and although Banyan hasn't firmed up pricing, its tests should be available for between $100 and $150, which would make them accessible to more people. Nordhoff added that obtaining FDA permission for marketing the test should bode well for securing reimbursement from insurers in the future.

Also, the 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," the FDA's Gottlieb said.

Citing CDC statistics Nordhoff noted that the estimated economic cost in the US of traumatic brain injury, including direct and indirect medical costs, is about $76.5 billion per year.