|Qiagen has teamed up with Clovis Oncology to develop a companion diagnostic on its Rotor-Gene Q MDx platform.--Courtesy of Qiagen|
Biotech Clovis Oncology ($CLVS) is tapping Qiagen's ($QGEN) diagnostic expertise as it develops an EGFR-targeting lung cancer treatment, tasking the German company with creating a companion test that can identify patients for clinical trials and, eventually, be sold alongside the drug.
Under the deal, Qiagen will develop a companion diagnostic for Clovis' CO-1686, an early-stage treatment for non-small cell lung cancer. For Qiagen, the agreement builds on its established success using its Therascreen platform to ferret out EGFR mutations, and the company won FDA approval over the summer for a similar test tied to Boehringer Ingelheim's cancer-fighting Gilotrif.
The pair are working on a CO-1686-specific version of the Therascreen EGFR RGQ PCR Kit, planning to file a supplemental FDA application that would allow drug and test to be approved in tandem. In the meantime, Clovis will use the not-yet-approved diagnostic to select patients for CO-1686's Phase II trial, which will enroll later this year.
"Together, we can accelerate the development of this important drug candidate and deliver a solution to an unmet medical need," Qiagen CEO Peer Schatz said in a statement.
Qiagen has become a go-to companion diagnostics partner since its 2012 high-profile FDA approval alongside Bristol-Myers Squibb ($BMY) and Eli Lilly's ($LLY) colorectal cancer drug Erbitux. The FDA attributed its quick-footed signoff on the drug to how well it could be targeted, a credit to Qiagen's accompanying KRAS RGQ PCR Kit. Since then, the company has nailed down tandem deals with Bayer, Pfizer ($PFE), Amgen ($AMGN) and others on the strength of its reputation for clinical and regulatory success.
For Clovis, CO-1686 is a promising early-stage drug that has until now stayed in the shadow of rucaparib, a PARP inhibitor that targets ovarian cancer. In June, the Colorado biotech's stock shot up roughly 80% on news that rucaparib benefited benefited a majority of patients in an early trial, and the company remains bullish that it carve out further success with both compounds.
- read the Clovis announcement
- here's Qiagen's statement