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BioMérieux Pneumonia Panels Get FDA 510(k) Clearance, CE Mark

NEW YORK (GenomeWeb) – A PCR-based panel assay from BioMérieux affiliate BioFire Diagnostics to detect 33 common pathogens causing lower respiratory tract infections has been granted 510(k) clearance by the US Food and Drug Administration.

Additionally, a version of the panel with an extra target has obtained CE mark.

The pneumonia panel test detects 18 bacteria and eight viruses, as well as seven genetic markers of antimicrobial resistance. The Plus version of the panel detects the same 33 targets as well as the MERS-CoV virus.

The panels are cleared for use on sputum and bronchoalveolar lavage samples, including endotracheal aspirate and so-called mini-BAL samples. The panels produce test results in about one hour and a few minutes of hands-on time.

In a statement, BioMérieux also noted that the assays yield semi-quantitative levels for 15 of the bacterial targets, which may help clinicians to differentiate colonization from true invasive infection. This marks the first time the FilmArray system has used its real-time PCR quantification capabilities commercially, and the first time that the FDA has cleared a semi-quantitative multiplex panel, according to BioMérieux.

The FilmArray system now has a total of nine syndromic panels, and a global installed base of about 7,600 units.

BioMérieux said that it will make the BioFire FilmArray Pneumonia Panel and BioFire FilmArray Pneumonia Panel Plus commercially available next month.