BioFire Diagnostics has been awarded $1.4 million from the National Institutes of Health for the first year of a planned three-year project to clinically validate the company's FilmArray gastrointestinal panel and help shepherd it through the US Food and Drug Administration approval process.
BioFire is currently setting up clinical testing sites for the assay with the hope of submitting the test to the US Food and Drug Administration by early 2014 in order to achieve regulatory clearance and commence sales later in the year, Wade Stevenson, director of marketing for clinical products at BioFire, told PCR Insider this week.
The new three-year grant, which commenced on July 1, is being administered by the National Institute of Allergy and Infectious Diseases, and is worth $1.4 million in its first year, with approximately $2.1 million in funding looming for the remaining two years. However, BioFire may not access all the funds available under the grant if its clinical testing and commercialization plan progresses as expected, Stevenson said.
Establishing clinical performance of the FilmArray GI Panel will entail testing of both prospectively collected, freshly tested specimens and preselected, known-positive archived specimens, according to the recently published grant abstract.
The analyte status of the specimens, the abstract added, must be determined by standard laboratory reference methods in order to calculate sensitivity and specificity of the GI Panel. These reference methods will include PCR-based assays that BioFire will need to design and validate.
Once the company achieves these goals, it will use the data — along with data collected under a previous NIH-funded project — to create regulatory documents for an FDA submission and to seek CE marking.
Last August, BioFire said that it anticipated commercially launching the GI panel by early 2014, but Stevenson this week reined in that timeline a bit, noting that the company now believes sometime in 2014 — likely the middle of the year — is a more realistic target.
The content of the GI Panel itself is also a bit of a moving target. In August the company said that the panel would be able to detect 25 different diarrheagenic pathogens, including bacteria, viruses, and protozoa. Meantime, the grant abstract notes that the panel detects 26 such organisms.
Stevenson told PCR Insider this week that the current iteration of the panel tests for 23 targets, a number that could yet change as the company moves toward an FDA submission.
"These things aren't always fixed, and it won't be until final FDA clearance," he said. "The targets we removed were some of the subtype[es]. We haven't changed the number of organisms we're targeting. We just altered the strategy and depth at which we're targeting some of those organisms."
BioFire, formerly Idaho Technology, has its roots in the biodefense market, and has been awarded federal funding on multiple occasions to develop tools and technologies that could prove useful in protecting US troops overseas or civilians in the case of a bioterror attack.
For instance, in 2003 Idaho Tech was awarded a contract under the Joint Biological Agent Identification and Diagnostic System, or JBAIDS, program, to develop a system to rapidly diagnose biological warfare agents and other pathogens of concern to the US military — a system that the company still sells today.
In addition, in March the company said it had inked a competitive prototyping contract with the US Army for the first increment of the Next-Generation Diagnostics System program, for which the company will optimize a FilmArray panel to detect biological warfare reagents in blood or environmental samples (PCR Insider, 3/28/2013).
However, the company has also parlayed this financial support into developing its products for routine clinical diagnostics applications. Indeed, the latest NIAID grant also has a biodefense slant in that 18 of the current 23 targets are NIAID Category B agents, a list that the agency compiles in conjunction with federal partners including the Department of Homeland Security and the Centers for Disease Control and Prevention.
Stevenson noted that the current project does not have biodefense applications, per se, but does have applications for "the general healthcare of war fighters and their families. They tend to visit exotic places and can pick up GI bugs at a higher frequency than we see here in the US. The military has expressed some interest in this panel, and some of the early test sites have been military sites."
If the GI Panel receives FDA approval, it will expand the test menu for the FilmArray instrument, which currently includes a respiratory viral panel and a blood culture identification panel.
The FilmArray Respiratory Panel simultaneously tests for 20 of the most common respiratory pathogens. A 15-target version of the panel initially received FDA approval in 2011, and the current expanded panel received clearance in May 2012.
Meantime, the FilmArray Blood Culture Identification Panel, which garnered FDA approval last month, tests for 27 targets, can identify more than 100 blood pathogens known to cause sepsis, and can identify a pathogen in nine out of 10 positive blood cultures in about one hour.
In general, the FilmArray platform integrates sample preparation, amplification, detection, and analysis, requiring minimal user interaction. It performs PCR to initially amplify nucleic acids from target pathogens, and uses melt curve analysis for multiplexed detection. Individual assays contain all necessary reagents in foil pouches.
All of BioFire's tests are intended to run on the same instrument platform. Thus, as the company expands its available menu, it is betting that clinical laboratories will have more interest in adopting the platform.
As far as the GI panel goes, with clinical trials set to begin, the company has "developed the product, it's looking really good coming out of R&D, and the preliminary data we've gotten back look really encouraging," Stevenson said.