QIAGEN, headquartered in Hilden, Germany, with US headquarters in Germantown, Md, and Clovis Oncology, Boulder, Colo, will co-develop and commercialize a companion diagnostic test to guide the use of CO-1686, a novel Clovis product candidate in clinical development.
The Clovis drug candidate will initially target an unmet clinical need in patients with epidermal growth factor receptor (EGFR) driven non-small cell lung cancer (NSCLC) for whom current EGFR-inhibiting drugs no longer control disease
The diagnostic will build on QIAGEN’s therascreen® EGFR RGQ PCR Kit, which was approved by the FDA in July 2013 as a companion diagnostic for use in the treatment of metastatic NSCLC in patients whose tumors have certain EGFR mutations.
Analytical performance of the therascreen EGFRtest has been established for 21 EGFR mutations, including the most prevalent resistance mutation, T790M. The test supports efficient lab workflow with real-time PCR technology on QIAGEN’s FDA-approved Rotor-Gene Q MDx (pictured), which is part of the QIAsymphony.
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.
Further terms of the agreement were not disclosed.