Qiagen Submits EGFR Companion Dx to FDA | GenomeWeb

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.

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