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April 3, 2014
06:33 EDTFMI, CLVSFoundation Medicine and Clovis Oncology partner for cancer diagnostic
Foundation Medicine (FMI) and Clovis Oncology (CLVS) are expanding their ongoing collaboration to incorporate a coordinated regulatory strategy for the development of a novel Premarket Approval companion diagnostic test. This test is designed for use by physicians to identify patients most likely to respond to rucaparib, Clovis’ poly polymerase inhibitor currently the subject of Phase 2 and Phase 3 clinical trials in patients with ovarian cancer. This companion diagnostic is being developed in parallel with the clinical development of rucaparib to facilitate an FDA submission of the PMA for the companion diagnostic concurrent with the New Drug Application for rucaparib.
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