Qiagen announced it has entered into a partnership with Pfizer Inc.  for the development of a companion molecular diagnostic test for use with an investigational Pfizer compound in global clinical development for treatment of non-small cell lung cancer (NSCLC). Financial terms of the agreement were not disclosed.

Pfizer's investigational compound, dacomitinib (PF-00299804), is an oral inhibitor of HER-1 (EGFR), HER-2 and HER-4 tyrosine kinases.  The HER (human epidermal growth factor receptor) signalling pathway plays a role in the complex process of cell growth and metastasis, making it a target for anti-cancer drugs.

Qiagen's proposed companion diagnostic will be based on its proprietary KRAS assay technology, which reliably detects mutations of the KRAS gene that are frequently found in human cancers. Because EGFR inhibitors are generally effective in patients without these KRAS mutations, 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 Healthcare as the global leader in partnering with pharmaceutical companies to create companion diagnostics. Using genomic information to guide each patient's treatment is transforming the practice of medicine," Dr. Little added. "In addition to more than 20 tests we already offer commercially, Qiagen is co-developing companion diagnostics in more than 15 pharma partnerships, a dynamic growth driver for our business."

Following clinical development of the KRAS companion diagnostic for NSCLC, Qiagen expects to submit a premarket approval application supplement (PMAS) to FDA for full automation of the workflow to allow pathologists easy access and processing of lung tissue samples.