QIAGEN has announced its intentions 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, as a companion diagnostic for use in the treatment of metastatic non-small-cell lung carcinoma (NSCLC) in patients whose tumors have certain EGFR mutations.
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. 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.
“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.
Patrick J. Mahaffy, President and CEO of Clovis Oncology, later added “Working with QIAGEN will help support our accelerated clinical development plan for CO-1686.”