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FDA Approves Expanded Use of Qiagen EGFR CDx in Lung Cancer

NEW YORK (GenomeWeb) – Qiagen announced today that the US Food and Drug Administration has approved the expanded use of the company's Therascreen EGFR RGQ PCR Kit to allow its use as a companion diagnostic for Pfizer's Vizimpro (dacomitinib) for first-line treatment of patients with non-small cell lung cancer with EGFR exon 19 deletions or exon 21 L858R mutation.

This is the third drug that the FDA has approved the Therascreen EGFR RGQ PCR kit for as a companion diagnostic. The agency also approved the kit as a CDx for Boehringer Ingelheim's Gilotrif (Afatinib) in 2013 and AstraZeneca's Iressa (Gefitinib) in 2015. The Therascreen EGFR RGQ PCR assay detects exon 19 deletions; L858R, L861Q, G719X, S768I, and exon 20 insertions; and the resistance mutation T790M in the EGFR gene using real-time PCR on the Rotor-Gene Q 5plex HRM instrument, according to Qiagen. The kit is optimized for rapid and sensitive detection of a low percentage of mutant DNA in a background of wild-type genomic DNA.

"As precision medicine becomes the standard of care in oncology, we are pleased to provide benefits to more lung cancer patients with our clinically proven Therascreen EGFR RGQ PCR Kit. Our collaboration with Pfizer has made great strides already and will continue to improve personalized healthcare for patients around the world," Jonathan Arnold, vice president and head of oncology and precision diagnostics for Qiagen, said in a statement.