Clovis, QIAGEN Partner To Develop Companion Diagnostic Test For CO-1686

(RTTNews) - Clovis Oncology (CLVS) announced that the company has signed an agreement with QIAGEN (QGEN) to develop a companion diagnostic test to identify the T790M resistance mutation in patients with epidermal growth factor receptor, or EGFR, driven non-small cell lung cancer, or NSCLC, for CO-1686. The diagnostic will build on QIAGEN's therascreen EGFR RGQ PCR Kit, which was approved by the U.S. FDA in July 2013 as a companion diagnostic used in the treatment of metastatic NSCLC in patients whose tumors have certain EGFR mutations. Terms of the agreement were not disclosed.

Clovis said, the diagnostic test is now being further developed in parallel with the clinical development of CO-1686, with the goal of filing a supplemental PMA application with the FDA in a time frame that would allow for regulatory approval of the companion diagnostic concurrent with CO-1686 approval.

The companies also have signed a non-exclusive Master Collaboration Agreement which will enable additional Clovis assets requiring supporting companion diagnostic assays to be rapidly developed using QIAGEN sample and assay technologies where appropriate.