Qiagen and Clovis Oncology Jointly to Develop Companion Diagnostic

The collaboration will expand the label of Qiagen’s United States Food and Drug Administration (FDA)-approved therascreen (EGFR) rotor gene Q (RGQ) polymerase chain reaction (PCR) kit and create the framework for a long-term development and commercialization partnership. The companion diagnostic test will 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).

The companion diagnostic test will 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 EGFR driven non-small-cell lung cancer (NSCLC) for which 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 US 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.

“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, CEO of Qiagen. “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.”

The Rotor-Gene Q MDx platform, which has been adopted by most major US laboratories and many labs around the world, runs a growing menu of molecular tests. Rotor-Gene Q MDx is approved in the US for use with Qiagen’s therascreen KRAS RGQ PCR Kit for colorectal cancer patients and therascreen EGFR test for metastatic NSCLC patients–important Personalized Healthcare products.

Qiagen continues to expand its pipeline of Personalized Healthcare technologies and intends to submit more tests around the world for regulatory approvals to run on the Rotor-Gene Q MDx. The company has more than 15 projects to co-develop and market companion diagnostics with pharmaceutical and biotech companies such as Amgen, AstraZeneca, Bayer, Bristol-Myers Squibb, Eli Lilly and Company, and Pfizer. Qiagen is developing numerous companion diagnostics, plus a range of other molecular tests, as part of a broad menu of reliable, cost-effective molecular diagnostics.

Clovis Oncology is a biopharmaceutical company focused on acquiring, developing, and commercializing cancer treatments in the United States, Europe, and other international markets.

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