NEW YORK (GenomeWeb) – Biocartis announced today that it has submitted its Idylla molecular diagnostics platform to the US Food and Drug Administration for 510(k) clearance, along with a respiratory panel from partner Janssen Diagnostics to detect influenza and respiratory syncytial virus using the Idylla platform.
Idylla is a rapid, fully automated molecular diagnostics system that uses pre-loaded, disposable test cartridges. The Janssen Idylla Respiratory IFV-RSV Panel cartridge was developed in a collaboration between Johnson & Johnson subsidiary Janssen Diagnostics and Biocartis, and was CE marked last year.
The firm noted that submission of the platform and test is an important milestone following the US distribution deal it signed with Thermo Fisher Scientific last month.
Biocartis also said today that it will expand its collaboration with Amgen for RAS biomarker testing, aiming to enable several dozen additional hospitals in Europe to accelerate access to RAS biomarker information using the Idylla platform and RAS tests for metastatic colorectal cancer applications. The CE-marked test has a turn-around-time of two hours, requires less than two minutes of hands-on time, and can be operated in any hospital laboratory. Amgen is already offering the test, which is being developed in partnership with Merck, in select countries.