NEW YORK (GenomeWeb) – Myriad Genetics announced today that it has established a European laboratory that will offer its Tumor BRACAnalysis CDx test to guide treatment with PARP inhibitors, namely AstraZeneca's olaparib.
According to Myriad, testing will be conducted in the company's lab in Munich, Germany and will be widely available throughout Europe.
Myriad announced the establishment of its European lab on the heels of an announcement this morning by the European Medicines Agency's Committee for Medicinal Products for Human Use, which recommended marketing authorization for olaparib as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed BRCA-mutated high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer.
According to Myriad, an estimated 22 percent of all ovarian cancer patients carry a deleterious germline or somatic BRCA mutation and thus 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," Colin Hayward, 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."
At the European Society for Medical Oncology's annual meeting in Madrid, Spain last month, researchers from Myriad and MD Anderson Cancer Center described a study comparing germline BRCA mutation testing against the more comprehensive Tumor BRACAnalysis CDx, which revealed that the latter was able to pick up 44 percent more deleterious markers in women with ovarian cancer.
In addition to olaparib, Myriad is also studying BRACAnalysis as a companion diagnostic with other drug developers in 13 Phase III studies covering six different indications.
Myriad hasn't provided a timeline for when it plans to launch the test in the US, but has said it intends to launch in line with olaparib's approval by the US Food and Drug Administration. The company submitted its first premarket approval module with the FDA for BRACAnalysis as a companion diagnostic for olaparib in April.