On May 17, 2022 QIAGEN reported the launch of the therascreen EGFR Plus RGQ PCR Kit, a new in-vitro diagnostic test for sensitive EGFR mutation analysis, detecting all currently known activating and resistance EGFR mutations (Press release, Qiagen, MAY 17, 2022, View Source [SID1234614716]). 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.

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In addition to the T790M mutation, the new kit now also detects C797S. This key biomarker indicates resistance to third-generation EGFR tyrosine kinase inhibitor [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.

"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."

Genomic testing is instrumental for patient management in non-small cell lung cancer, 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 8 hours, providing next-day results and informing earlier treatment decisions.

QIAGEN is a pioneer in Precision Medicine, particularly through its therascreen assay portfolio that allow the detection of clinically relevant genetic alterations to provide insights that guide clinical decision-making in diseases such as cancer.

To learn more about EGFR mutation testing in NSCLC, visit www.qiagen.com/EGFR-Plus.