Skip to main content
Premium Trial:

Request an Annual Quote

Qiagen Gets CE Mark for Therascreen EGFR Plus RGQ Kit for Non-Small Cell Lung Cancer

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.

The Scan

Pig Organ Transplants Considered

The Wall Street Journal reports that the US Food and Drug Administration may soon allow clinical trials that involve transplanting pig organs into humans.

'Poo-Bank' Proposal

Harvard Medical School researchers suggest people should bank stool samples when they are young to transplant when they later develop age-related diseases.

Spurred to Develop Again

New Scientist reports that researchers may have uncovered why about 60 percent of in vitro fertilization embryos stop developing.

Science Papers Examine Breast Milk Cell Populations, Cerebral Cortex Cellular Diversity, Micronesia Population History

In Science this week: unique cell populations found within breast milk, 100 transcriptionally distinct cell populations uncovered in the cerebral cortex, and more.