Qiagen Launches RT qPCR Test for Sensitive Detection of EGFR Mutations to Guide NSCLC Treatment

Lung cancer is the leading cause of cancer mortality, worldwide. In Europe, it is the second most diagnosed cancer in men and the third in women, with over 477,500 new cases in 2020. Non-small cell lung cancer (NSCLC) makes up about 85% of those cases. Many oncogenes are known to play a role in NSCLC. Mutations in the EGFR gene occur in ~15% of NSCLC adenocarcinomas (rising significantly – up to 63% – in Asian populations). The presence of certain EGFR mutations predicts for sensitivity to EGFR tyrosine kinase inhibitors (TKIs) and confers a more favorable prognosis. Mutation analysis is the go-to method for to determine the presence or absence of a driver mutation in EGFR and enables oncologists to decide whether to use an EGFR TKI for initial treatment of a patient with advanced NSCLC. Now, a new in-vitro diagnostic test for sensitive EGFR mutation analysis detects all currently known activating and resistance EGFR mutations and supports treatment decision making.

QIAGEN N.V. (Venlo, Netherlands) has launched the therascreen EGFR Plus RGQ PCR Kit, an in-vitro diagnostic test for sensitive EGFR mutation analysis, detecting all currently known activating and resistance EGFR mutations. The real-time qPCR test builds on the established therascreen EGFR RGQ PCR Kit and provides improved limits of detection, quicker turnaround times, automated sample extraction options and automated results analysis. In addition to the T790M mutation, the new kit now also detects C797S. This key biomarker indicates resistance to third-generation EGFR TKI, giving oncologists additional insights to adjust EGFR treatment for NSCLC patients. The kit also delivers next-day results and automated analysis, making it an ideal choice for labs that require a high-performing test solution for either tissue or plasma with a rapid turnaround.

Genomic testing is instrumental for patient management in NSCLC, and testing for driver mutations in EGFR aids oncologists to make informed treatment decisions for patients. The therascreen EGFR Plus RGQ PCR Kit is a more cost-effective and simpler alternative to NGS for routine follow-up testing once an EGFR mutation is known. The kit can test FFPE and plasma samples within the same run, allowing for matched testing of FFPE and plasma and removing the need for laboratories to batch samples of either type before a run. The decreased invasiveness of plasma sampling allows clinicians to schedule routine testing of patients on treatment to track treatment effectiveness and establish whether resistance is occurring.

Extraction can be performed manually or automated on the QIAsymphony SP for walkaway sample processing. Sensitive real-time PCR is then performed on the Rotor-Gene Q MDx 5plex HRM instrument with automated data analysis using Rotor-Gene AssayManager software. The software displays qualitative results informing the operator if one or more of the 42 EGFR mutations are present. The Sample to Insight workflow can be completed in under eight hours, providing next-day results and informing earlier treatment decisions.

“The therascreen EGFR Plus RGQ PCR Kit combines sensitivity in mutation detection with the flexibility to test both tissue and liquid samples, helping oncologists to make confident, informed treatment decisions for patients with advanced NSCLC,” said Kai te Kaat, Vice President, Head of Global R&D Molecular Diagnostics at QIAGEN. “With this launch, we continue to further advance our Precision Medicine portfolio by covering new clinically relevant mutations such as C797S that further improve patient outcomes.”

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