Belgium-based molecular diagnostics company Biocartis Group has secured a CE mark for its fully automated Idylla GeneFusion Panel (CE-IVD).
The panel detects a wide range of actionable targets relevant to non-small cell lung cancer (NSCLC) in a single cartridge ALK, ROS1, RET, and METex14 skipping.
The panel, designed for use in clinical laboratories, delivers testing results in 180 minutes, quicker than the existing accessible testing methods that take days or weeks to provide results.
According to the firm, the Idylla GeneFusion Panel combines the existing testing methods into a single, fully automated approach.
Biocartis said that the panel requires a small amount of sample which eventually saves precious tissue specimens.
In a clinical comparison study, the Idylla GeneFusion Panel showed high concordance results when ALK was compared to IHC, and ROS1, RET, and METex14 skipping were compared to NGS.
Biocartis chief executive officer Herman Verrelst said: “Turnaround time and time-to-treatment remains an important barrier to molecular testing.
“It has been demonstrated that 10% to 20% of advanced lung cancer patients do not receive the appropriate targeted therapy because biomarker results are not provided in a timely fashion.
“With the CE-marked IVD of the Idylla GeneFusion Panel, laboratories will have a rapid actionable and in-house solution at their disposal which can be seamlessly integrated into virtually any laboratory workflow.”
In November 2020, the company signed a license, development and commercialisation agreement with GeneproDx for the development of its genomic test ThyroidPrint on Biocartis’ molecular diagnostics Idylla platform.
