Qiagen scores FDA approval for lung cancer companion Dx

Qiagen's Thierry Bernard

Qiagen ($QGEN) snagged FDA approval for its test for AstraZeneca's ($AZN) lung cancer drug, building on its previous relationship with the pharma titan to claim more ground in the companion diagnostics field.

The Netherlands-based company got a regulatory greenlight for its therasceen EGFR RGQ PCR kit for AstraZeneca's Iressa med for metastatic non-small cell lung cancer (NSCLC). Qiagen's test screens tumors for EGFR gene mutations to see which patients are suitable for treatment with AstraZeneca's drug. Non-small cell lung cancer accounts for about 85% of new cases of lung cancer in the U.S. each year, and testing for EGFR mutations is believed to be the largest segment in companion diagnostics, Qiagen said in a statement, allowing the company to cash in on a lucrative market.

"We are very pleased to offer the therascreen EGFR test in the United States to guide the use of Iressa, a further milestone in personalized medicine for lung cancer patients. Qiagen's leadership in companion diagnostics continues to grow, transforming patient care around the world," Thierry Bernard, head of Qiagen's Molecular Diagnostics unit, said in a statement.

This is not the first time Qiagen and AstraZeneca have teamed up for companion diagnostics. The companies also joined forces to co-develop Qiagen's therascreen kit, laying the foundation for future collaborations with the product.

But Qiagen is also working with other biopharma heavyweights to expand its footprint in the field. The diagnostics giant has more than 20 collaborative projects underway, including an ongoing partnership with drugmaker Eli Lilly ($LLY) geared toward cancer testing and a cancer companion diagnostics deal with Novartis ($NVS).

Last month, Qiagen launched a joint venture with German molecular diagnostics company Biotype Diagnostics. The venture, dubbed "Biotype Innovation," will develop and market molecular tests based on Qiagen's rapid ModaPlex tool, helping physicians select the best treatments for patients. Qiagen will have worldwide distribution rights for the tests while Biotype will cover markets in Germany, Austria and Switzerland.

- read Qiagen's statement
- here's the FDA release

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