CemarkingDubai Blog

Myriad Genetics Gets CE Marking for Its Tumor BRACAnalysis CDx Test

Tumor BRACAnalysis CDx is the first and only tumor-based companion diagnostic that is CE-marked and can identify patients that would be appropriate for Lynparza, a poly ADP-ribose polymerase or PARP inhibitor. "Obtaining a CE Marking for Tumor BRACAnalysis CDx is a significant milestone and achievement for the Myriad team. The CE Mark allows us to offer a validated tumor-based test for use as a companion diagnostic with Lynparza and future PARP inhibitors in Europe," said Gary King, executive vice president, International Operations, Myriad. Last month, the European Medicines Agency approved Lynparza as monotherapy for maintenance treatment of adult patients with platinum-sensitive relapsed BRCA-mutated (germline and/or somatic) high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy.