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Qiagen Submits EGFR Companion Dx to FDA

NEW YORK (GenomeWeb News) – Qiagen today said that it has submitted its therascreen EGFR RGQ PCR kit to the US Food and Drug Administration as a proposed companion diagnostic for Boehringer Ingelheim's non-small cell lung cancer drug afatinib.

Qiagen said that it had submitted a Premarket Approval application for use of the test to determine which NSCLC patients would be potentially eligible for treatment with afatinib. The therascreen EGFR test was developed in collaboration with Boehringer Ingelheim.

Afatinib was granted a priority review by the FDA as a proposed treatment of patients with locally advanced or metastatic NSCLC with an EGFR mutation detected by an FDA-approved test. The drug also was submitted for European approval in September 2012, and the therascreen EGFR test already has received the CE Mark. In addition, the test has received marketing approval in Japan.

"Submission of therascreen EGFR test, which runs on Rotor-Gene Q, is another milestone for our Personalized Healthcare franchise," Qiagen CEO Peer Schatz said in a statement. "The therascreen EGFR test will add to QIAGEN's menu of other therascreen assays including the therascreen KRAS RGQ PCR Kit launched last year in the US."