Abstract
Qiagen has signed a second companion diagnostics deal with Pfizer, this time to develop a molecular test for use with Pfizer’s investigational compound dacomitinib (PF-00299804), which is in Phase III development for non-small-cell lung cancer (NSCLC). The deal covers clinical trials and submissions for a premarket approval (PMA) application in the US and the CE mark in Europe, along with applicable regulatory approvals in other regions. The companion diagnostic, which will be based on Qiagen’s KRAS assay technology, will be used to identify those patients that are most likely to respond to dacomitinib by detecting KRAS gene mutations that are frequently found in human cancers.
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