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Qiagen EGFR Assay Approved in Japan as CDx to Pfizer NSCLC Drug

NEW YORK (GenomeWeb) – Qiagen said Wednesday that its Therascreen EGFR RGQ PCR kit has been approved by the Japanese Pharmaceuticals and Medical Device Agency as a companion diagnostic with Pfizer's Vizimpro (dacomitinib) for EGFR mutation-positive, inoperable, or recurrent non-small cell lung cancer.

Qiagen's test detects the most frequently occurring somatic mutations (exon 19 deletions, L858R, L861Q, G719X, S768I, exon 20 insertions, and the resistance mutation T790M) in EGFR in less than four hours using real-time PCR on the Rotor-Gene Q platform, a module in Qiagen's QiaSymphony family of instruments.

The kit is registered in more than 40 countries, and it is Qiagen's first companion diagnostic approval in Japan.

"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," Jonathan Arnold, vice president and head of oncology and precision diagnostics for Qiagen, said in a statement.