Biocartis Group NV: Idylla(TM) Respiratory (IFV-RSV) Panel receives 510(k) clearance by US FDA

Biocartis Group NV (the 'Company' or 'Biocartis'), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announces that the US Food and Drug Administration (FDA) has granted 510(k) clearance[1] for the Idylla(TM) Respiratory (IFV-RSV) Panel, a fully automated molecular diagnostic test, developed by Janssen Diagnostics, LLC ('Janssen'). 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(TM). 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, commented:

"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."

 

On 12 July 2017, Biocartis announced the exemption by the US FDA of its Idylla(TM) Instrument and Idylla(TM) Console, which are no longer subject to 510(k) notification requirements prior to being placed on the US market for in vitro diagnostic use with US FDA approved or cleared assays. In Q3 2017, Biocartis launched the commercialization of its oncology menu (for research use only) in the US through its subsidiary, Biocartis Inc., and in collaboration with Thermo Fisher Scientific Inc.

Note

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. 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 ten oncology tests and two infectious disease tests in Europe. More information: www.biocartis.com. Press Photo Library available here. Follow us on Twitter: @Biocartis_.

 

 

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