Qiagen seeks FDA sign-off for lung cancer companion Dx
Qiagen ($QGEN) disclosed it is seeking the FDA's blessing for a lung cancer-drug companion diagnostic, a test designed to screen patients for whom Boehringer Ingelheim's investigational treatment might work.
Qiagen wants premarket approval for the test. It's an EGFR (epidermal growth factor receptor) diagnostic designed to determine which patients with locally advanced or metastatic non-small cell lung cancer will benefit from Boehringer Ingelheim's afatinib, a drug that targets patient's cancer with the specific EGFR mutation. Over the summer, the company disclosed a successful late-stage trial where the drug helped slow progression of the disease and boost survival rates.
Qiagen is moving fast in tandem with its drug partner. Boehringer Ingelheim also announced that the FDA accepted its new drug application for afatinib--with a hoped-for approval date sometime in the 2013 third quarter. That makes the success of Qiagen's test extremely important considering the drug it is paired with. As the companies note, afatinib recently gained orphan drug designation. If approved, the drug would provide treatment for a stage and type of lung cancer for which there are no approved FDA therapies. So the success of the drug would be major, giving those patients a treatment option they've never had. And Qiagen's companion diagnostic will advance the field of personalized medicine in a major way, helping to aggressively pinpoint those folks.
Qiagen's test already has CE marking and gained regulatory approval in Japan--which the company notes is the second largest personalized healthcare market in the world.
Qiagen has focused a lot of recent energies on developing companion diagnostics. Back in October, the company signed a deal with Bayer to develop companion diagnostics designed to go alongside Bayer's existing cancer drugs. Qiagen has also disclosed it has more than 15 companion diagnostic projects under way with both pharmaceutical and biotech companies.