Banyan Biomarkers Inc. is getting $7 million in funding from in vitro diagnostics specialist Biomérieux SA to help develop a blood test for traumatic brain injury (TBI). In addition, the Marcy L'etoile-France-based company has also obtained the right to commercialize Banyan's TBI tests with its Vidas immunoassays range platform.

Banyan's test uses two brain specific protein biomarkers (Banyan UCH-L1 and Banyan GFAP) that rapidly appear in the blood after a brain injury. The San Diego-based company was founded in 2002 and is a spin off from the University of Florida.

"We are excited about the Biomérieux partnership because they have a very strong global presence with the Vidas family instrumentation," Tony Grover, vice president of business development for Banyan, told Medical Device Daily. "It will give us a chance to really get our biomarkers out there."

Grover said the company hopes to submit an FDA application for approval of its biomarkers for TBI in 2Q17.

"We are expecting this to be a clinical [in vitro diagnostic] test," Grover said. "This is not a research use only test."

To date, the company has had some success with previous studies of the UCH-L1 and GFAP biomarkers.

Results published in the November 2015 edition of Journal of Neurotrauma, show that UCH-L1 and GFAP, are detectable in blood shortly after a TBI. The prospective multi-center observational study included 251 patients with mild to moderate TBI who presented to seven emergency departments in the U.S. and Europe. All patients in the study underwent a CT scan as part of routine care and had blood drawn for biomarker analysis within six hours of injury.

According to the paper, the results demonstrate that within six hours of injury, UCH-L1 was very sensitive in identifying patients with a positive CT scan of the head. The authors also analyzed S100B, another potential blood based biomarker for TBI, and determined that S100B was not able to achieve the same performance as UCH-L1.

EXTRA FIREPOWER FOR BIOMÉRIEUX

The partnership stands to be beneficial to Biomérieux, which has had strong organic growth because of its Filmarray rapid test for infectious diseases, but now faces off against a growing number of competitors.

"If [Biomérieux's] impressive growth continues then the impact on product mix will be positive, but competitive threats may be looming," said Peter Welford an analyst with Jefferies.

The firm's margins were challenged from Basel, Switzerland-based Roche Holding AG's Smarticles Mdx technology for the rapid ID of resistant bacteria and antibiotic susceptibility. Roche acquired the technology when it picked up Geneweave Biosciences Inc. for $425 million. (See Medical Device Daily, Aug. 14, 2015.) The test cuts out the need for culturing.

Welford cited more competition for the company in the form point-of-care testing platforms, which include Genmark Diagnostics Inc.'s Eplex; Danaher Inc.'s Genexpert Omni and T2 Biosystems Inc.'s sepsis offerings.

Welford said that to ward off competitors Biomérieux's management must "execute further acquisitions to fend-off competitive threats, notably from potentially disruptive products."

NOT TIED DOWN IN TBI EFFORTS

Banyan's lifeblood comes from its partnerships with large medical device firms. In January 2016, the company was able to add Amsterdam-based Royal Philips NV to its growing list of collaborators.

The two entered into a multi-year joint development agreement to develop and commercialize a new handheld blood test to detect and evaluate mild TBI at the point of care. The new handheld test is based on Philips' Minicare I-20 system. The financial details of the agreement were not disclosed.

The company has a license agreement – dating back to 2014 – to use its assays on Abbott Laboratories Inc.'s Istat device, Grover said.

Banyan scored another high profile partnership with Lexington, Mass.-based Quanterix Corp. in August. (See Medical Device Daily, Aug. 2, 2016.) Under the agreement, the Quanterix Simoa platform would incorporate the Banyan UCH-L1 and Banyan GFAP assays to help further neurological research for improved TBI diagnosis and treatment.

"I really think companies are starting to realize this will be the future of diagnostics," Grover said in response to the Banyan's numerous partnerships. "The ability to get this information about the brain to health care providers to improve patient outcomes is extremely important to the patient, the caregiver, the family and payers as well."