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The FilmArray® Respiratory Panel 2 plus (RP2plus) gets CE marked
20 Aprile, 2017bioMérieux, a world leader in the field of in vitro diagnostics, today announced that the FilmArray® Respiratory Panel 2 plus (RP2plus) is CE marked. The FilmArray® RP2plus panel tests for 22 pathogens (18 viruses and 4 bacteria) responsible for respiratory tract infections and will be commercially available in the countries that recognize CE marking by mid-June, 2017. In parallel, a 510(k) application has been submitted to the FDA.
The FilmArray® RP2plus advances the existing FilmArray® Respiratory Panel (RP) by reducing the assay time from about an hour to less than 45 minutes, improving overall sensitivity, and updating several assays. FilmArray® RP2plus also includes 2 additional pathogens: Bordetella parapertussis, one of the causative agents of pertussis or whooping cough, a highly infectious bacterial disease, and Middle East Respiratory Syndrome coronavirus (MERS-CoV).
According to the WHO, the recent MERS-CoV outbreak in the Republic of Korea demonstrated a great potential for widespread transmission and severe disruption both to the health system and to society. The MERS-CoV case fatality rate is approximately 36%1.
Bordetella parapertussis infections represent a significant cause of whooping cough which is often missed because of a clinical presentation largely indistinguishable from other viral infections and of lack of reliable diagnostic tests.
Randy Rasmussen, bioMérieux Corporate Vice President of Molecular Biology and CEO of BioFire Diagnostics, said: “FilmArray® is the world leading syndromic molecular technology. bioMérieux 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”. Rasmussen continues, “The reduced turnaround time of FilmArray® RP2plus allows samples to be processed and then gives results in less than 45 minutes helping to ensure rapid and adequate care for patients.”
The FilmArray® RP2plus is available for use on the FilmArray® 2.0 and FilmArray® Torch Systems. The Company plans to continue to make the current FilmArray® RP panel commercially available.
1 WHO website: http://www.who.int/mediacentre/factsheets/mers-cov/en/ and http://www.who.int/emergencies/mers-cov/en/