Biocartis Group NV

Biocartis announces launch of Influenza-Respiratory Virus Panel on the Idylla(TM) platform

Mechelen, Belgium, 30 November 2015 - Biocartis (Euronext Brussels: BCART), an innovative molecular diagnostics company, today announces the launch of its first infectious disease test on the Idylla(TM) platform. The Idylla(TM) Respiratory IFV-RSV Panel has been developed by Janssen Diagnostics and is intended for the detection of various strains of Influenza Virus (IFV) and Respiratory Syncytial Virus (RSV). The Idylla(TM) Respiratory IFV-RSV Panel received CE-IVD marking on 18 November 2015 and is being launched for commercial use in Europe and other geographies recognising the CE-mark. Janssen Diagnostics has appointed Biocartis as co-exclusive worldwide distributor of the test.

Respiratory viruses are one of the most important causes of morbidity and mortality throughout the world^[1] with the influenza virus killing at least 50 million and up to 100 million people in the last century alone^[2]. The majority of diagnostic tests currently used for this market are rapid immunoassays which are chosen due to their low cost and convenience. However, one of the key downsides of these rapid tests is their poor sensitivity. Negative samples are typically re-tested in a central lab with a more sensitive molecular test, delaying time-to-result by many hours. The new Idylla(TM) Respiratory IFV-RSV Panel, running on the Idylla(TM) platform, combines in one single product the speed of rapid tests with the quality and sensitivity standards of central lab tests.

The Idylla(TM) Respiratory IFV-RSV Panel is designed for the qualitative detection of nucleic acids of Influenza A, Influenza A subtype H1, Influenza A subtype H3, Influenza A subtype 2009 H1, H275Y mutation of Influenza A subtype 2009 H1, Influenza B and Respiratory Syncytial Virus (RSV) subtype A and RSV subtype B from nasopharyngeal swabs (NPS^[3]) of adult and pediatric patients, using the Idylla(TM) molecular diagnostics platform to aid in the diagnosis of respiratory viral infection.

Thanks to the fully integrated workflow and outstanding ease-of-use of the Idylla(TM) platform, the Idylla(TM) Respiratory IFV-RSV Panel can be performed in as little as 50 minutes and requires less than one minute of hands-on time.

After Biocartis launched its solid biopsy BRAF Mutation Test for melanoma and solid biopsy KRAS Mutation Test for colorectal cancer, this Idylla(TM) Respiratory IFV-RSV Panel is the first of a series of infectious disease tests that Biocartis and its partners are developing for use on the Idylla(TM) platform.