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BioFire Boosts BioMerieux Q1 Revenues; Biodefense Contract on Hold due to Focus Dx Legal Protest

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NEW YORK (GenomeWeb) — BioMérieux said this week that its first quarter revenues increased 3 percent year over year but 8 percent when including sales from recent acquisition BioFire Diagnostics and at constant exchange rates.

In addition, PCR Insider has learned that a contract awarded by the US military to recently formed BioMérieux subsidiary BioFire Defense to develop a biothreat detection platform has been put on hold due to a formal legal protest by Focus Diagnostics, which competed with BioMérieux for the contract.

For the three months ended March 31, Marcy L'Etoile, France-based BioMérieux, which trades on the NYSE Euronext Paris market, reported net sales of €371 million ($512.5 million) compared to €359 million in the year-ago period.

BioMérieux's first quarter 2014 sales for the first time included revenues from BioFire Diagnostics, the acquisition of which BioMérieux completed in mid-January for approximately €357 million.

BioFire, based in Salt Lake City, markets FilmArray, a CE-marked, US Food and Drug Administration-cleared multiplex PCR diagnostic system that combines real-time PCR and melt curve analysis to enable "syndromic" diagnoses, i.e. interrogating and identifying multiple disease-causing organisms based on patient symptoms. FilmArray's menu includes CE-marked and FDA-cleared syndromic respiratory and sepsis panels.

Based on two and a half months of consolidation in the quarter, BioFire contributed sales of €14 million, including €12 million in FilmArray sales. BioMérieux said that FilmArray sales delivered growth of around 60 percent year over year, with particularly strong sales in North America.

BioMérieux breaks its earnings out into Clinical Applications, which includes Microbiology, Immunoassays, Molecular Biology, and Other; and Industrial Applications. In Q1, Clinical Applications revenues rose 4 percent to €296.8 million from €286 million in the comparable period last year.

Besides the FilmArray product line, BioMérieux's Clinical Molecular Biology offerings include instrumentation such as the easyMAG sample purification platform, easySTREAM liquid handling system for PCR assay set-up, Life Technologies' (Thermo Fisher Scientific) real-time PCR instruments, and NucliSentral software; as well as Argene real-time PCR assays specific for immunocompromised patients and respiratory and meningo-encephalitis infections.

Sales of these products represented about €78 million in 2012, a BioMérieux spokesperson told PCR Insider in an email.

A full breakdown of BioMérieux's Q1 earnings can be found here.

In conjunction with the BioFire acquisition, BioMérieux created a wholly owned subsidiary called BioFire Defense to focus on US military contracts. In February 2014, the US Department of Defense awarded BioFire Defense the $240 million Next Generation Diagnostic System (NGDS) technology development contract, under which BioFire Defense planned to expand the FilmArray menu to include biothreat targets.

The NGDS program is being administered through the Joint Project Management Office for Medical Countermeasures (formerly known as Chemical Biological Medical Systems) within the Joint Program Executive Office for Chemical and Biological Defense (JPEO-CBD), located in Fort Detrick, Md.

In February 2013, BioFire Defense, then called BioFire Diagnostics, was one of three companies — including Focus Diagnostics (a subsidiary of Quest Diagnostics) and IQuum (since acquired by Roche) — to share a $23.1 million competitive prototyping contract from the Department of Defense to develop the NGDS platform.

Although BioMérieux won the competition and was awarded the $240 million contract in February, the company noted this week that a legal protest action was initiated by a competing company.

A US Department of Defense spokesperson confirmed with PCR Insider this week that Focus Diagnostics filed the legal protest, and in accordance with Federal Acquisition Regulations, the agency issued a stop-work order to BioFire Defense at the end of March.

The spokesperson declined to provide additional details about the legal protest, citing confidentiality.

A BioMérieux spokesperson said that it is working with government officials on this issue, and added that a delay of up to six months would not drastically affect BioFire sales, although the spokesperson did not know how long the legal protest process would take.

On deadline, Focus Diagnostics did not return a request for comment.

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