NEW YORK – Qiagen said Tuesday that it has obtained the CE mark for the Therascreen EGFR Plus RGQ PCR Kit — an in vitro diagnostic test for EGFR mutation analysis in non-small cell lung cancer — and has launched the assay in 11 countries that accept the designation.
A new iteration of the firm's previous Therascreen EGFR RGQ PCR Kit, the IVD assay detects all 42 currently known activating and resistance EGFR mutations using real-time quantitative PCR, with improved limits of detection and quicker turnaround times.
In addition to the T790M mutation, the new version also detects C797S, a biomarker of resistance to third-generation EGFR tyrosine kinase inhibitor therapy. It also delivers next-day results and features automated analysis. It is applicable to FFPE tissue and plasma, even in the same run.
EGFR testing has become instrumental in NSCLC patient management. The detection of driver mutations can make patients eligible for treatment with targeted therapies, while detection of resistance mutations allows swift, informed shifts in care.
Qiagen said customers can perform sample extraction for the assay either manually or using the QIAsymphony SP instrument, followed by real-time PCR on the Rotor-Gene Q MDx 5plex HRM instrument and automated data analysis using Rotor-Gene AssayManager software.