AstraZeneca Partners with Foundation Medicine for Companion Diagnostic
AstraZeneca has entered into a definitive agreement with Foundation Medicine, Inc., a molecular information company, to develop a companion diagnostic assay for Lynparza (olaparib) to support its global development program. The companion diagnostic will enable physicians to identify those patients most likely to benefit from AstraZeneca's poly ADP-ribose polymerase (PARP) inhibitor.
Lynparza is an oral PARP inhibitor that exploits tumor DNA repair pathway deficiencies to preferentially kill cancer cells. This mode of action gives Lynparza the potential for activity in a range of tumor types with DNA repair deficiencies. It is approved in the US for the treatment of patients with germline BRCA-mutated advanced ovarian cancer and in the European Union for patients with platinum-sensitive relapsed BRCA-mutated high-grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer.
Under the agreement, Foundation Medicine will develop and make available a regulatory approved product utilizing the quality systems regulations (QSR) compliant version of its FoundationOne genomic profiling platform. This assay will detect multiple classes of genomic alterations across a range of genes involved in homologous recombination pepair (HRR). The assay, based on a scientifically selected panel of genes known to be involved in driving the HRR process, will be developed alongside the clinical program for Lynparza, as part of a coordinated drug-diagnostic regulatory strategy.