NEW YORK (GenomeWeb) – Myriad Genetics today announced that it has received CE marking in Europe for its Tumor BRACAnalysis CDx test.
The test identifies tumors with mutations in the BRCA1 and BRCA2 genes. Myriad said that Tumor BRACAnalysis CDx is the only CE-marked tumor-based companion diagnostic test. It identifies patients who may benefit from AstraZeneca's Lynparza (olaparib), a poly ADP-ribose polymerase inhibitor.
The European Medicines Agency and the US Food and Drug Administration approved Lynparza last month as a monotherapy for maintenance treatment of patients with platinum-sensitive relapsed BRCA-mutated high-grade serious epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy. FDA also approved Myriad's test as a companion diagnostic for the drug.
The test is offered throughout Europe by Myriad's subsidiary based in Zurich and is performed in the firm's Munich laboratories.