This article has been corrected from a previous version to indicate that Janssen Diagnostics received CE marking for the Idylla Respiratory IFV-RSV Panel.
NEW YORK (GenomeWeb) – Belgian molecular diagnostics company Biocartis announced today that its partner Janssen Diagnostics has received CE-IVD marking for the Idylla Respiratory IFV-RSV Panel, which runs on Biocartis' fully automated PCR-based Idylla platform.
Concurrently, Biocartis has launched the test in Europe and other geographies recognizing CE mark. Janssen developed the panel and has named Biocartis as co-exclusive worldwide distributor.
Unlike rapid immunoassay tests, which often have poor sensitivity in detecting the influenza virus, this new panel will combine speed with the sensitivity of central lab tests, Biocartis said in a statement. The panel qualitatively detects nucleic acids from influenza A as well as subtypes H1, H3, and 2009 H1; the H275Y mutation of influenza A subtype 2009 H1; influenza B; and respiratory syncytial virus subtypes A and B. Running the test on the Idylla molecular diagnostics platform requires a nasopharyngeal swab from a patient, and takes about 50 minutes to run with less than a minute of hands-on time, the company added.
Biocartis has already launched a solid biopsy BRAF mutation test for melanoma and a solid biopsy KRAS mutation test for colorectal cancer for the Idylla platform. The company also plans to launch a series of infectious disease tests for the platform, including a test for Ebola.
"The combination of oncology and infectious disease tests demonstrates the versatility of our Idylla platform," said company CEO Rudi Pauwels in a statement.