The development plan for the companion diagnostic complements Clovis Oncology's accelerated plan for CO-1686 development by potentially allowing a supplemental premarket approval (PMA) filing for the diagnostic. Subject to regulatory approvals, QIAGEN will be responsible for the global development and commercialization of the companion diagnostic, and Clovis will be responsible for the global development and commercialization of CO-1686. The partners also created the framework for possible future collaborations, thereby adding another master agreement to QIAGEN's growing pipeline of collaborations with some of the world's leading pharmaceutical and biotechnology companies. Further terms of the agreement were not disclosed.
"We are pleased to partner with Clovis Oncology in developing a companion diagnostic based on QIAGEN's therascreen technology and to expand the label of our approved therascreen EGFR kit. Together, we can accelerate the development of this important drug candidate and deliver a solution to an unmet medical need," said Peer Schatz, QIAGEN's Chief Executive Officer. "Our therascreen EGFR kit, approved by the FDA based on extensive analytical and clinical data, is the most comprehensive test and offers unique features such as detection of actionable mutations in separate tubes. QIAGEN is a preferred partner in personalized medicine because of our ability to deliver reproducible results, the efficient workflow of our platforms, and our track record in development and regulatory approvals."
"We are pleased to collaborate with QIAGEN for the development of a companio
|SOURCE Qiagen N.V.|
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