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QIAGEN and Pfizer Partner to Develop Companion Diagnostic for Novel Compound in Global Clinical Trials for Lung Cancer
Date:8/16/2011

, the QIAGEN assay can be useful in identifying patients most appropriate for EGFR-inhibitor therapies. QIAGEN recently submitted the application for Premarket Approval (PMA) for KRAS companion diagnostics to the FDA for use with two other, separate drugs targeting metastatic colorectal cancers. The Pfizer drug companion diagnostic test is being specifically developed for use in lung cancer tissue. It uses the same core assay component as the therascreen KRAS RGQ kit for colorectal cancers but varies in the workflow to allow for lung tissue-specific sample technology in a fully automated workflow.

QIAGEN and Pfizer will engage in collaborative efforts to develop the KRAS companion diagnostic for use with dacomitinib (PF-00299804). The global partnership covers clinical trials and submissions for a PMA application in the United States and the CE mark in Europe, as well as applicable regulatory approvals in other regions.

"We are pleased to collaborate with Pfizer seeking to advance personalized healthcare with a new potential tool in the fight against non-small cell lung cancer, a major killer around the world," commented Dr. Stephen Little, Vice President Personalized Healthcare at QIAGEN. "This partnership unites QIAGEN's capabilities in companion diagnostics with Pfizer's scientific excellence and global presence to develop an innovative diagnostic-therapeutic combination with the potential to improve the standard of care for NSCLC patients."

Lung cancer is the most common cancer globally in incidence and mortality. About 1.1 million new cases are reported each year in males, with 0.95 million deaths, and 0.51 million new cases per year are reported in females, with 0.43 million deaths. Worldwide, approximately 85% of all lung cancers are classified as non-small cell lung cancer, with a five-year survival rate of only about 15%.

"QIAGEN has invested deeply in Personalized Healt
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SOURCE QIAGEN N.V.
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