|Qiagen's lung cancer diagnostic with its Rotor-Gene Q MDx platform--Courtesy of Qiagen|
Two months after Roche ($RHHBY) gained a similar FDA approval, Qiagen ($QGEN) won the nod for its own molecular diagnostic designed to spot a specific EGFR lung cancer mutation. Qiagen's Therascreen EGFR test works in tandem with Boehringer Ingelheim's targeted Gilotrif treatment, a tyrosine kinase inhibitor designed to block proteins that spur cancer growth.
It's the third FDA-approved test that works with Qiagen's Rotor-Gene Q MDx platform. It helps spot non-small cell lung cancer patients with specific EGFR mutations, who benefit most from the drug.
Non-small cell lung cancer is the most common kind of lung cancer, and the approval of both Boehringer's drug and Qiagen's test was the second in 2013 focused on the EGFR lung cancer space. While the test will address a major medical need, the market isn't necessarily enormous. Qiagen, a company based in the Netherlands, said it expects as many as 120,000 patients globally could gain from EGFR mutation tests. But that market is worth about $35 million, Qiagen estimated at the time.
Qiagen scores FDA nod for lung cancer companion Dx