QIAGEN, Pfizer team up on companion diagnostic

QIAGEN ($QGEN) has entered into a partnership with pharma titan Pfizer for the development of a companion molecular diagnostic test for use with an investigational compound in global clinical development for treatment of non-small cell lung cancer (NSCLC). The partnership covers clinical trials and submissions for a PMA application in the U.S. and CE mark in Europe, as well as applicable regulatory approvals in other regions. Financial terms of the agreement were not disclosed.

The companion diagnostic will be based on QIAGEN's proprietary KRAS assay technology, which 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 the patients most appropriate for EGFR-inhibitor therapies. Pfizer's investigational compound, dacomitinib (PF-00299804), is an oral inhibitor of HER-1 (EGFR), HER-2 and HER-4 tyrosine kinases.

Lung cancer is the most common cancer globally. Worldwide, approximately 85% of all lung cancers are classified as NSCLC, with a 5-year survival rate of only about 15%.

QIAGEN has been on a roll as of late. Earlier this month, it completed its second U.S. submission for the therascreen KRAS RGQ PCR kit as a companion diagnostic for Erbitux (cetuximab), which is used by metastatic colorectal cancer patients. That followed on the heels of another submission of the KRAS assay in July that paired QIAGEN's molecular test with another drug for the treatment of metastatic colorectal cancer. Both therapies are monoclonal antibody EGFR inhibitors expected to target a range of cancers.

- see QIAGEN's release