Biocartis gets FDA clearance for Idylla Respiratory

Biocartis Group got clearance for the Idylla Respiratory (IFV-RSV) Panel from the US Food and Drug Administration (FDA). Idylla Respiratory Panel is a fully automated molecular diagnostic test, developed by Janssen Diagnostics.

The Idylla(TM) Respiratory (IFV-RSV) Panel runs on the Biocartis Idylla(TM) platform.

Biocartis’ strategic partner Janssen led the submission process of this premarket notification and developed the test intended for the detection of various strains of Influenza Virus (IFV) and Respiratory Syncytial Virus (RSV), using Biocartis’ molecular diagnostics platform Idylla. Thanks to the fully integrated workflow and ease-of-use of this platform, the Idylla(TM) Respiratory (IFV-RSV) Panel can be performed in approx. 50 minutes, requires less than two minutes hands-on time, and operates from nasopharyngeal swab[2]samples in viral transport media.

Erwin Sablon, Head of R&D and Alliance Management of Biocartis, said: “We want to congratulate our strategic partner Janssen for obtaining this US FDA clearance. This is an impressive achievement of both our teams. It also marks an important milestone for Biocartis, as this is the first US FDA cleared test on our Idylla(TM) platform, adding yet another layer of validation to the quality of our product offering.”