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GERMANTOWN, Maryland, and HILDEN,
October 21, 2013 /PRNewswire/ --
Collaboration to expand label of QIAGEN's FDA-approvedtherascreen®EGFR RGQ PCR Kit and creates framework for long term development and commercialization partnership
Companion diagnostic will run on QIAGEN's efficient Rotor-Gene Q MDx platform
QIAGEN adds to growing portfolio of companion diagnostics in co-development with world's leading pharmaceutical and biotechnology companies
QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced a partnership with Clovis Oncology (NASDAQ: CLVS) to co-develop and co-commercialize a companion diagnostic test to guide the use of CO-1686, a novel Clovis Oncology product candidate currently 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 U.S. Food and Drug Administration (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 EGFR test has been established for 21
EGFR mutations, including the most prevalent resistance mutation, T790M. The test supports efficient laboratory workflow with real-time PCR technology on the FDA approved Rotor-Gene Q MDx, which is part of the QIAsymphony family of laboratory solutions.
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.