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BioFire

The 45-minute test was developed by BioMérieux subsidiary BioFire Defense and can be used on the company's FilmArray and FilmArray Torch systems.

Test makers are preparing to ramp up production of new SARS-CoV-2 assays and designated testing systems in anticipation of increased demand.

Labrador Diagnostics, a firm controlled by an investment group that acquired Theranos' IP, alleged BioFire's FilmArray products infringe two patents.

SARS-CoV-2 viral material is available for test validation, and the FDA is conducting a rolling review process with an abbreviated submission template.

In the quarter, the firm entered a partnership with Specific Diagnostics and also submitted an enhanced version of its blood culture ID panel for regulatory clearance.

Qiagen, which is also developing a single-plex qRT-PCR assay for SARS-CoV-2, said it will have a syndromic panel including targets for the virus ready this month.

The new test increases the multiplexing of the sepsis panel from 26 targets to 43 targets, including seven additional resistance genes.

Luminex has since fixed the problem with a software update but a similar issue with non-specific amplification has also affected two targets on BioFire's GI panel. 

In the quarter the firm acquired food and beverage testing firm Invisible Sentinel and partnered with Baxter International to develop acute kidney injury biomarkers.

The firm also reported full-year 2018 sales of €2.42 billion, a year-over-year increase of 6 percent on a reported basis, or 10 percent organically.

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