NEW YORK (GenomeWeb) – Biocartis announced today that its Idylla Respiratory Panel (IFV-RSV) has been granted 510(k) clearance by the US Food and Drug Administration.
Developed by Janssen Diagnostics, the respiratory panel detects various strains of the influenza virus and respiratory syncytial virus and runs on the Biocartis Idylla platform, a fully automated sample-to-result, real-time PCR system. The IFV-RSV panel is a single-use assay intended to detect the viruses' nucleic acid signatures. Clinicians can perform the assay in 50 minutes via nasopharyngeal swab samples in viral transport media. The panel requires less than two minutes of hands-on time.
"[This] marks an important milestone for Biocartis, as this is the first US FDA-cleared test on our Idylla platform, adding yet another layer of validation to the quality of our product offering," Erwin Sablon, Biocartis' head of R&D and alliance management, said in a statement.
Biocartis submitted its Idylla platform to the FDA for approval, along with the respiratory panel from Janssen, last December.
Earlier this year, Biocartis received a CE mark for its EGFR mutation test, which allows the detection of 51 EGFR mutations from a single slice of FFPE tissue.