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Tumor BRACAnalysis CDx will “Identify More Patients for Treatment With PARP Inhibitors”
Myriad Genetics, Inc. (Nasdaq:MYGN) today announced it has established a Tumor BRACAnalysis CDx laboratory in Europe. Myriad’s next-generation Tumor BRACAnalysis CDx test is a companion diagnostic that will identify up to 50 percent more patients with BRAC mutations who may benefit from treatment with PARP inhibitors, such as olaparib, compared to conventional germline testing alone.
Olaparib is a novel PARP inhibitor being developed by AstraZeneca. Earlier today, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended marketing authorization for olaparib as monotherapy for the 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 response (complete or partial) to platinum-based chemotherapy. It is estimated that more than 22 percent of all ovarian cancer patients carry a deleterious germline or somatic mutation in the BRCA1 or BRCA2 genes and may benefit from olaparib therapy.
“BRCA mutation screening is critical in ovarian cancer patients to identify the subset of women who might benefit from PARP inhibitors,” said Colin Hayward, M.D., 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, significantly increasing the total number of patients who may benefit from this life-saving drug.”
More than eight years ago, Myriad pioneered the development of germline BRCA testing as a companion diagnostic for use with PARP inhibitors and other agents. The new Tumor BRACAnalysis CDx test will expand the reach of this important new therapeutic class to many more ovarian cancer patients. Tumor BRACAnalysis CDx will be widely available throughout all of Europe and testing will be conducted in the Company’s laboratories in Munich, Germany. Key features of the Tumor BRACAnalysis CDx test are:
– Up to 50 percent additional BRCA-deficient tumors detected to more accurately identify patients who are candidates for therapy with olaparib;
– Expected 3 percent variant of uncertain significance (VUS) rate for BRCA1/BRCA2 mutations, ensuring a clearer management pathway for ovarian cancer patients;
– An average 14-day laboratory turnaround time, allowing physicians and patients to make critical treatment decisions.
Last month at the European Society for Medical Oncology (ESMO) annual meeting in Madrid, Spain, Myriad presented a study analyzing approximately 130 previously untreated, high-grade ovarian cancer patients for germline BRCA mutations in blood samples and somatic mutations in tissue samples. In the study, the 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 percent of patients were found to have germline mutations through a blood test. Meanwhile, testing with the Tumor BRACAnalysis CDx test identified all 20 percent of patients with germline mutations and an additional eight percent of patients with a somatic BRCA1/BRCA2 mutation, representing a 44 percent increase in the number of mutations identified.
“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 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.”
