.gif)
Biocartis Group NV (‘Biocartis’), an innovative molecular diagnostics company (Euronext Brussels: BCART), announced the 510(k) submission to the U.S. Food and Drug Administration (FDA) of its rapid, fully automated molecular diagnostics platform Idylla™, consisting of the Idylla™ Instrument and the Idylla™ Console.
The submission was done in parallel with the 510(k) submission by Biocartis’ strategic partner Janssen Diagnostics (a Janssen Pharmaceutical Company) of the Janssen Idylla™ Respiratory (IFV-RSV) Panel Test. This test, developed by Janssen Diagnostics on the Idylla™ 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™ 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.”
