Qiagen NSCLC Companion Diagnostic Lands PMA Approval

Qiagen won FDA premarket approval Monday for its therascreen epidermal growth factor receptor test as a companion diagnostic to guide the use of AstraZeneca’s Iressa (gefitinib) in patients with advanced or metastatic non-small cell lung cancer.

The test allows doctors to identify NSCLC patients with tumors that are positive for EGFR mutations, making them candidates for Iressa treatment, the Dutch devicemaker says. The product has been on the market since 2013 as a companion diagnostic for another NSCLC drug.

Iressa also received FDA approval on Monday, as the first and only first-line treatment for patients with the disease.

According to company estimates, NSCLC accounts for an estimated 85 percent of new lung cancer cases diagnosed in the U.S., leading to about 160,000 deaths annually. — Jason Scott