Qiagen scores FDA nod for lung cancer companion Dx

Qiagen won FDA approval for a lung cancer diagnostic that works on its Rotor-Gene Q MDx platform.--Courtesy of Qiagen

Qiagen's ($QGEN) string of companion diagnostics success continues with the FDA's approval of a molecular test for lung cancer, OK'd alongside a targeted Boehringer Ingelheim drug.

The test, Therascreen EGFR, charts a gene mutation that leads to non-small cell lung cancer, finding patients likely to benefit from Boehringer's targeted Gilotrif treatment. It's the third FDA-approved test based on Qiagen's Rotor-Gene Q MDx platform, and the company estimates the market for EGFR testing at around $35 million.

Boehringer's drug is a tyrosine kinase inhibitor, designed to block proteins that spur cancer growth. In its most recent data, Gilotrif patients had an average rate of progression-free survival of 11.1 months, compared to 6.9 months for those on standard therapy. For cancer sufferers with two specific EGFR mutations, that rate ticked up to 13.6 months, demonstrating the value of Therascreen's patient selection.

The latest approval follows the FDA's blessing for Therascreen KRAS, Qiagen's colorectal cancer test used in tandem with Bristol-Myers Squibb ($BMY) and Eli Lilly's ($LLY) Erbitux. That test already accounts for more than half of the U.S.' KRAS testing volume, CEO Peer Schatz said, and Qiagen expects similar success as it breaks into the EGFR market.

Qiagen has amped up its companion diagnostic efforts over the past year, signing deals with Bayer, Pfizer ($PFE), Amgen ($AMGN) and other pharma heavyweights who see a path to success through targeted therapies. And the company is working to secure its pipeline, in May licensing a bevy of cancer biomarkers it said could light the way to future companion diagnostics.

The FDA has made quite clear its affinity for personalized medicine, and Gilotrif's approval is the product of the agency's new priority review program, giving Qiagen and Boehringer a fairly quick trip through the regulatory process after filing in January.

"The approval of companion diagnostic tests and drugs are important developments in oncology, as they help us bring safe and effective treatments to patients who need them," FDA diagnostics director Alberto Gutierrez said in a statement.

- read Qiagen's statement
- check out the FDA release
- here's FierceBiotech's take

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