Biocartis submits 510(k) file with US FDA for Idylla(TM) platform
Submission done in parallel with 510(k) submission of Janssen Idylla(TM) Respiratory (IFV-RSV) Panel Test by Janssen Diagnostics
The submission was done in parallel with the 510(k) submission by Biocartis' strategic partner Janssen Diagnostics (a Janssen Pharmaceutical Company of Johnson & Johnson) of the Janssen Idylla(TM) Respiratory (IFV-RSV) Panel Test. This test, developed by Janssen Diagnostics on the Idylla(TM) platform, is intended for the detection of various strains of Influenza Virus (IFV) and Respiratory Syncytial Virus (RSV).
Following the announcement of Biocartis' partnership with Thermo Fisher Scientific Inc. on 17 November 2016, the 510(k) submission of its molecular diagnostics platform Idylla(TM) is another important milestone for Biocartis towards establishing a commercial presence in the US.
Rudi Pauwels, Chief Executive Officer of Biocartis, commented: "This 510(k) submission was a joint effort between the teams of Janssen Diagnostics and Biocartis, and another great achievement resulting from the longstanding strategic partnership between both companies. The experience of the Janssen Diagnostics' team has been of much added value in preparing for this submission and we want to thank our partner for their continued commitment and support."
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 Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification - also called PMN or 510(k).
Biocartis (Euronext Brussels: BCART) is an innovative molecular diagnostics (MDx) company providing next generation diagnostic solutions aimed at improving clinical practice for the benefit of patients, clinicians, payers and industry. Biocartis' proprietary MDx Idylla(TM) platform is a fully automated sample-to-result, real-time PCR (Polymerase Chain Reaction) system that offers accurate, highly reliable molecular information from virtually any biological sample in virtually any setting. Biocartis launched the Idylla(TM) platform in September 2014 in Europe. Biocartis is developing and marketing a rapidly expanding test menu addressing key unmet clinical needs in oncology and infectious diseases. These areas represent respectively the fastest growing and largest segments of the MDx market worldwide. Today, Biocartis offers six oncology tests and two infectious disease tests in Europe. More information: www.biocartis.com. Press Photo Library available here. Follow us on Twitter: @Biocartis_.