Myriad Genetics has established a Tumor BRACAnalysis CDx™ laboratory in Europe. Testing is to be conducted in the company's laboratories in Munich, with the tumor test to be widely available within Europe, Myriad said.

Tumor BRACAnalysis CDx is a companion diagnostic designed to identify up to 50% more patients with BRAC mutations who may benefit from treatment with olaparib and other PARP inhibitors compared to conventional germline testing alone.

Other key features of the Tumor BRACAnalysis CDx test, according to Myriad, include an expected 3% variant of uncertain significance (VUS) rate for BRCA1/BRCA2 mutations, ensuring a clearer management pathway for ovarian cancer patients; and an average 14-day laboratory turnaround time, giving physicians and patients more time to make treatment decisions.

Myriad’s announcement of the lab came on the same day the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended marketing authorization for olaparib 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.

More than 22% of all ovarian cancer patients are estimated to carry a deleterious germline or somatic mutation in the BRCA1 or BRCA2 genes. According to the company, these patients may benefit from therapy through olaparib, a PARP inhibitor being developed by AstraZeneca.

“BRCA mutation screening is critical in ovarian cancer patients to identify the subset of women who might benefit from PARP inhibitors,” Colin Hayward, M.D., Myriad’s European medical director, said in a statement. “Tumor BRACAnalysis CDx testing is the best method for screening ovarian cancer patients because it detects both germline and somatic mutations, significantly increasing the total number of patients who may benefit from this life-saving drug.”

Last month at the European Society for Medical Oncology (ESMO) annual meeting in Madrid, Spain, Myriad presented results from a study analyzing about 130 previously untreated, high-grade ovarian cancer patients for germline BRCA mutations in blood samples and somatic mutations in tissue samples. Researchers also tested patients undergoing surgery for both of these types of mutations.

Of 92 patients who were tested for both germline and somatic markers, nearly 20% of patients were found to have germline mutations through a blood test. Myriad said testing with the Tumor BRACAnalysis CDx test identified that entire 20% sub-population and an additional 8% of patients with a somatic BRCA1/BRCA2 mutation, representing a 44% increase in the number of mutations identified.

In the U.S., testing via the Tumor BRACAnalysis CDx will be carried out at Myriad’s lab in Salt Lake City.

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