Qiagen gets FDA nod for colorectal cancer Dx

Qiagen ($QGEN) is poised to cash in on the FDA's approval of Erbitux for colorectal cancer, as the agency also OK'd the Dutch firm's companion diagnostic for the top-selling cancer drug.

The expanded indication tabs Erbitux to treat colorectal cancer in the 60% patients who lack a mutation of the KRAS gene that makes them unresponsive to the drug. Qiagen's therascreen KRAS test is now FDA-approved to identify that population, Bloomberg reports.

Last year, Erbitux--made by Bristol-Myers Squibb ($BMY) and Eli Lilly ($LLY)--pulled in $691 million in sales, and the market potential for Qiagen's test is about $20 million per year, according to Bloomberg's analysis. It's Qiagen's first FDA-approved companion diagnostic, and its CEO said the regulatory nod is an affirmation of the firm's work and of the expanding importance of personalized medicine.

"With a growing portfolio of innovative tests and efficient automation platforms, we are proud to be helping to make healthcare more effective, providing ways for payers to more efficiently use healthcare resources and, most important, making a positive impact on the care of patients," Peer Schatz said in a statement.

The firm has already signed up labs around the world to administer the diagnostic, and it has plans to apply for further diagnostic approvals. Qiagen has 15 pipeline assays to be paired with treatments, the company said, co-developing companion diagnostics with Amgen ($AMGN), AstraZeneca ($AZN) and Pfizer ($PFE), among others.

- read the company's statement
- here's FiercePharma's take
- get more from Bloomberg

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