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UPDATE: BioFire Ramping up FilmArray Adoption, Test Development

The story has been updated to correct the market size figure for BioFire Diagnostics' GI and respiratory tests and to correct the previous name of the company.

NEW YORK (GenomeWeb News) – Though it is a relatively new player in the molecular diagnostics space, Salt Lake City-based BioFire Diagnostics sees "tremendous opportunity" for growth during the next 12 to 24 months, its CEO said today.

As part of the Goldman Sachs Emerging Healthcare series, BioFire CEO Kirk Ririe said that in the past year, the company, formerly known as Idaho Technology, has grown its installed base of FilmArray instruments from zero to about 200 systems, and its immediate goal is to continue bumping up that number as well as the number of tests run on the PCR-based platform.

In all, the company plans to have panels covering five disease areas within "the next couple of years," Ririe said on the Goldman Sachs conference call.

BioFire currently sells a US Food and Drug Administration-approved respiratory virus panel. As GenomeWeb Daily News' sister publication PCR Insider reported previously, the company chose not to commercialize an earlier version of the test last year, but instead chose to submit another application to FDA for an updated test with additional viral targets. This past May, that test was cleared by the agency.

Ririe said that BioFire is now working on a blood-culture identification panel and is about halfway through FDA-mandated studies. The company anticipates launching the test in the European Union in the first quarter of 2013 and in the US in the latter half of 2013.

The panel, Ririe said, is a gram-positive and gram-negative panel aimed at sepsis, a market that he pegged at "a few million" tests each year.

After that, BioFire is targeting gastrointestinal infections with a panel under development that includes 23 common causes of diarrhea. The addressable market for the GI panel and respiratory panel combined is about 13 million tests each year translating to $1 billion with a growth rate of 15 percent annually.

Further out, the company is eyeing diagnostics for meningitis and pneumonia, Ririe added.

Founded in 1990 as a molecular biology tools firm, BioFire is still very active in the applied markets, biosurveillance, and food safety businesses, but the "biggest and most rapidly growing part of our commercial sales business is already the diagnostics business," Ririe said.

Its customer base is primarily hospitals that want to run their molecular-based tests in-house. As a result, BioFire doesn't consider its biggest competitors to be other firms that sell molecular diagnostic platforms and tests to the hospital environment, such as Cepheid, GenMark, and Nanosphere, but rather reference and national laboratories that run MDx tests for the hospitals, he said.

"That's the status quo of the molecular diagnostic industry, and our goal is to change that paradigm," Ririe said.

A reference laboratory may be appropriate in applications that don't require rapid results, but in the case of infectious diseases, time is crucial to a physician trying to decide on a treatment regimen. "So, the doctors have these time critical needs and for those applications that's really what we're going after," he said. "We're targeting a few set of symptoms where lots of different pathogens can cause the symptoms."

The list price on the FilmArray platform is $49,000, although BioFire provides a discount based on the number of systems bought, President and COO Randy Rasmussen said on the conference call. The list price on consumables for the respiratory and GI tests is $129.

Last week, BioFire said that it received $25 million in an investment from Athyrium Opportunities Fund to accelerate commercialization of its platform and test panels. The company also was recently awarded a $27.4 million contract from the US Department of Defense.

BioFire has been privately held throughout its 22-year history, but Ririe left open the possibility that that may change.

"We're really looking for all available options to finance a steeper growth rate both in the installed base and to accelerate those products," he said. "We've been able to bootstrap ourselves to the point we're at now. However, going forward that looks … like it's not going to be a winning solution."

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