Tumor BRAC Analysis CDx Lab Established in Europe

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has now recommended marketing authorization for olaparib as monotherapy for the maintenance-treatment of candidate adult patients [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 response (complete or partial) to platinum-based chemotherapy]. It is estimated that over 22% of all ovarian cancer patients carry a deleterious germline or somatic mutation in the BRCA1 or BRCA2 genes and may benefit from olaparib therapy.

Key features of the Tumor BRACAnalysis CDx test are: Up to 50% additional BRCA-deficient tumors detected to more accurately identify candidate patients for olaparib therapy; Expected 3% variant of uncertain significance (VUS) rate for BRCA1/BRCA2 mutations, ensuring a clearer patient management pathway; An average 14-day laboratory turnaround time.

"BRCA mutation screening is critical in ovarian cancer patients to identify the subset of women who might benefit from PARP inhibitors," said Colin Hayward, MD, European medical director at Myriad. "Tumor BRACAnalysis CDx testing is the best method for screening ovarian cancer patients because it detects both germline and somatic mutations."

Myriad pioneered the development of germline BRCA testing as a CDx for PARP inhibitors and other agents. The new Tumor BRACAnalysis CDx test will expand the reach of this important new therapeutic class. It will be widely available throughout Europe; testing will be conducted in Myriad's laboratories in Munich, Germany.

"Several clinical studies have shown that the Tumor BRACAnalysis CDx test outperformed germline testing alone in terms of identifying more patients who are candidates for treatment with PARP inhibitors," said Dr. Hayward. "We believe these results combined with the positive CHMP recommendations for olaparib will open doors to a new era of personalized medicine for patients with platinum-sensitive ovarian cancer by helping target PARP therapy to the right patients."

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