FDA OK's Qiagen companion Dx for use with Amgen colon cancer drug

Qiagen CEO Peer Schatz

Qiagen ($QGEN) gained FDA approval for a companion diagnostic test that will help spot patients with metastatic colorectal cancer who might benefit most from Amgen's ($AMGN) drug Vectibix. The regulatory milestone represents another advance in the Dutch company's growing focus on personalized medicine.

Regulators approved Qiagen's latest Therascreen test to screen metastatic colon cancer patients for a KRAS mutation. Patients with the mutation can begin treatment with Vectibix, which recently gained FDA approval as a first-line treatment for wild-type KRAS metastatic colorectal cancer. (The drug can be used in combination with Folfox chemotherapy and has previous approval as a second-line therapy for colorectal cancer patients with EGFR-expressing genes.) KRAS mutations can be found in about 40% of colorectal cancer patients, Qiagen noted. A specialized test goes a long way to advancing into practice the idea of enabling targeted, and hopefully more effective, treatments for colon cancer patients. Colon cancer is often hard to diagnose until it is relatively far advanced, and so a targeted treatment that addresses a cancer's unique genetic signature can make all the difference at that point.

Qiagen CEO Peer Schatz said in a statement that the KRAS test approval as a companion test for Vectibix is the company's 25th molecular diagnostic that focuses on companion diagnostic biomarkers. Schatz noted in a statement that the approval "marks a further milestone for Qiagen's global growth in companion diagnostics for personalized healthcare."

Qiagen won U.S. approval in 2013 for its Therascreen EGFR test that screens lung cancer patients for a specific EGFR mutation; such patients might benefit from Boehringer Ingelheim's Gilotrif treatment. Qiagen's Therascreen KRAS test is also FDA-approved to identify colorectal cancer patients who might benefit most from Erbitux, a drug made by Bristol-Myers Squibb ($BMY) and Eli Lilly ($LLY).

Qiagen has marketed its Therascreen KRAS and EGFR kits in Japan since 2011. As well, the company sells a number of assays in Europe that screen for KRAS, EGFR, NRAS, BRAF, PI3K, JAK2, MGMT, UGT1A1 and other biomarkers.

- read the release

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