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FDA Approves Qiagen's Therascreen EGFR Test as CDx for AstraZeneca NSCLC Drug

NEW YORK (GenomeWeb) – The US Food and Drug Administration today approved Qiagen's therascreen EGRF test as a companion diagnostic test for AstraZeneca's Iressa (gefitinib) for the first-line treatment of patients with metastatic non-small lung cancer. 

The drug was approved for patients with tumors that harbor specific types of EGFR gene mutations, the FDA said in a statement. Iressa is a kinase inhibitor that blocks proteins that promote the development of cancerous cells with the mutations, and the FDA approved Qiagen's therascreen EGFR RGQ PCR Kit to identify patients with the mutations to determine which ones would benefit from the drug. 

In a separate statement, Thierry Bernard, senior vice president and head of the molecular diagnostics business area for Qiagen said that the FDA approval of the therascreen EGFR CDx "is another highlight in Qiagen's ongoing, successful collaboration with AstraZeneca. This marks Qiagen's fourth US approval of a companion diagnostic.

"As the second FDA-approved use of therascreen EGFR in NSCLC, the pairing with Iressa also expands Qiagen's US market leadership in EGFR testing," he said. 

The agency previously approved the therascreen EGFR test in 2013 as a CDx for Boehringer Ingelheim's Gilotrif (afatinib) for treating NSCLC. FDA said that mutations in the EGFR gene are present in about 10 percent of NSCLC tumors.