MARCY L’ÉTOILE, France--(BUSINESS WIRE)--Regulatory News:
bioMérieux (Paris:BIM), 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.
About the FilmArray® System:
The FilmArray® System is an FDA-cleared and CE-marked multiplex PCR system that integrates sample preparation, amplification, and detection into one closed system. The FilmArray® System requires only two minutes of hands-on time and has a total run time of about 45 to 65 minutes, depending on the panel. The FilmArray® System has the largest infectious disease pathogen menu commercially available composed of:
- FilmArray® Respiratory Panel, a comprehensive panel of 20 respiratory viruses and bacteria performed directly on nasopharyngeal swab-associated viral transport media.
- FilmArray® Blood Culture Identification (BCID) Panel, capable of identifying 27 of the most common causes of bloodstream infections and antimicrobial resistance directly from positive blood culture.
- FilmArray® Gastro-Intestinal (GI) Panel, for identification of 22 of the most common causes of infectious diarrhea directly from stool in Cary Blair transport media.
- FilmArray® Meningitis-Encephalitis (ME) Panel, identifying 14 bacterial, viral, and fungal causes of meningitis and encephalitis directly from cerebrospinal fluid.
- FilmArray® RP EZ for the detection of 11 viral and 3 bacterial pathogens associated with respiratory infections FDA cleared and CLIA waived for use in the U.S. only.
As of March 31, 2017, the number of FilmArray® Systems installed globally reached about 4,500 units.
A world leader in the field of in vitro diagnostics for more than 50 years, bioMérieux is present in more than 150 countries through 42 subsidiaries and a large network of distributors. In 2016, revenues reached €2,103 million, with more than 90% of international sales.
bioMérieux provides diagnostic solutions (reagents, instruments, software) which determine the source of disease and contamination to improve patient health and ensure consumer safety. Its products are mainly used for diagnosing infectious diseases. They are also used for detecting microorganisms in agri-food, pharmaceutical and cosmetic products.
bioMérieux is listed on the Euronext Paris market (Symbol: BIM – ISIN: FR0010096479).
Investor website: www.biomerieux-finance.com