Myriad Genetics announced that the company has obtained CE marking in Europe for its Tumor BRACAnalysis CDx test, which identifies tumors that have mutations in the BRCA1 or BRCA2 genes.
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 (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’s (EMA) 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.
It is estimated that more than 28 percent of ovarian cancer patients carry a deleterious germline or somatic mutation in the BRCA1 or BRCA2 genes and may benefit from Lynparza therapy.
In clinical studies conducted by Myriad, the Tumor BRACAnalysis CDx test identified up to 44 percent more cancer patients with BRCA mutations who are candidates for treatment with PARP inhibitors, compared to conventional germline BRCA testing alone.
"The trend in modern medicine is toward tailored therapy that will give patients the best chance for successful outcomes. In ovarian cancer, it is critical to identify which patients have somatic or germline BRCA mutations and may benefit from the new class of PARP inhibitors," said Colin Hayward, M.D., European medical director, Myriad.