BioMerieux receives CE Mark for Respiratory Panel 2 plus

BioMerieux has announced that its new FilmArray Respiratory Panel 2 plus has been granted European CE Mark approval.

The new FilmArray RP2plus will become commercially available in the countries that recognise the CE Mark in mid-June, while a similar application has already been submitted to the US Food and Drug Administration.

Offering improvements compared to the existing FilmArray Respiratory Panel, the new product tests for 22 pathogens – 18 viruses and four bacteria – that are responsible for causing respiratory tract infections.

It is capable of reducing the assay time from about an hour to less than 45 minutes, while improving overall sensitivity and updating several assays. It also includes two additional pathogens: bordetella parapertussis, a key cause of whooping cough, and the Middle East respiratory syndrome coronavirus.

The new panel is will be made available for use on the FilmArray 2.0 and FilmArray Torch systems.

Randy Rasmussen, corporate vice-president of molecular biology at BioMerieux and chief executive officer of BioFire Diagnostics, said: "FilmArray is the world-leading syndromic molecular technology. BioMerieux is highly committed to keeping its diagnostic solutions relevant to currently circulating pathogens and to continuously increasing the medical value its products deliver to healthcare systems."

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