US-based molecular diagnostic firm Myriad Genetics has established a new laboratory in Europe for the Tumour BRACAnalysis CDx test, which is a companion diagnostic to identify 50% more patients with BRAC mutations for treatment with PARP inhibitors.
The company already developed germline BRCA testing as a companion diagnostic for use with PARP inhibitors and other agents.
It is believed the new tumour BRACAnalysis CDx test will expand the reach of this new therapeutic class to more patients with ovarian cancer.
Tumour BRACAnalysis CDx will now be available throughout Europe and testing will be conducted at the company’s laboratories in Munich, Germany.
Myriad European medical director Dr Colin Hayward said: "BRCA mutation screening is critical in ovarian cancer patients to identify the subset of women who might benefit from PARP inhibitors.
"Tumour 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.
"Several clinical studies showed that the Tumour BRACAnalysis CDx test outperformed germline testing alone in terms of identifying more patients who are candidates for treatment with PARP inhibitors.
"We believe these results combined with the positive CHMP recommendations for olaparib will open doors to a new era of personalised medicine for patients with platinum-sensitive ovarian cancer, by helping target PARP therapy to the right patients."
Olaparib is a new PARP inhibitor being developed by AstraZeneca and it received recommendation for marketing from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).
The CHMP recommended marketing authorisation 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 who are in response to platinum-based chemotherapy.
Last month, the company presented a trial analysing 130 previously untreated, high-grade ovarian cancer patients for germline BRCA mutations in blood samples and somatic mutations in tissue samples.
The trial also tested patients undergoing surgery for both types of mutations.
Out of the 92 patients who were tested for both germline and somatic markers, nearly 20% were found to have germline mutations through a blood test.
The Tumour BRACAnalysis CDx test identified all 20% of patients with germline mutations and an additional 8% of patients with a somatic BRCA1/BRCA2 mutation, representing a 44% increase in the number of mutations identified.