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FDA Approves Qiagen's Therascreen EGFR as CDx for Boehringer Ingelheim's NSCLC Drug

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has approved for marketing Qiagen's therascreen EGFR test as a companion diagnostic test for Boehringer Ingelheim's new targeted treatment for metastatic non-small cell lung cancer, Qiagen said today.

FDA approved Qiagen's test for Boehringer Ingelheim's therapy called Gilotrif (afatinib), which is used for treating NSCLC in patients who have tumors with certain EGFR mutations. Gilotrif is indicated for NSCLC patients with EGFR exon deletions and exon 21 L858R substitution deletions, the most common mutations in the EGFR gene.

Qiagen said that NSCLC accounts for 85 percent of the 200,000 new cases of lung cancer diagnosed in the US each year and leads to an estimated 160,000 deaths.

The company submitted the therascreen EGFR test to FDA in January.

The test identifies EGFR mutation-positive patients eligible for treatment with Gilotrif.

Today's development is the third FDA-approved or cleared diagnostic kit running on Qiagen's Rotor-Gene Q MDx platform, a real-time PCR instrument, and is the second FDA-approved companion diagnostic to run on the system, Qiagen said.

Rotor-Gene Q MDx received 510(k) clearance from the FDA in April 2012. The first therascreen test to receive FDA approval was the therascreen KRAS test, which was approved a year ago as a companion diagnostic for Erbitux (cetuximab) for treating colorectal cancer patients.

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