Myriad's companion diagnostic Tumor BRACAnalysis CDx gains CE mark

Myriad Genetics said Thursday that its Tumor BRACAnalysis CDx test, which identifies tumours that have mutations in the BRCA1 or BRCA2 genes, gained a CE mark. Gary King, executive vice president of international operations, noted that the decision "allows us to offer a validated tumour-based test for use as a companion diagnostic with Lynparza and future PARP inhibitors in Europe."

AstraZeneca's Lynparza (olaparib) was approved last month by the European Commission for the treatment of patients with advanced BRCA-mutated ovarian cancer. Earlier in December, the FDA cleared BRACAnalysis CDx as a companion diagnostic test to be used in conjunction with Lynparza.

Myriad noted that the test's approval makes it the only CE marked tumour-based companion diagnostic with this indication. The company added that it is estimated that more than 28 percent of patients with ovarian cancer carry a mutation in the BRCA1 or BRCA2 genes. Myriad indicated that in clinical trials, the Tumor BRACAnalysis CDx test identified up to 44-percent more patients with cancer and BRCA mutations who were candidates for PARP inhibitor treatment, compared to conventional germline BRCA testing alone.

According to Myriad, the Tumor BRACAnalysis CDx test is offered throughout Europe at its laboratories in Munich, Germany. The test has an average 14-day laboratory turnaround time.

Last month, Myriad lost a US appeal to block competing products to its BRCA gene sequencing tests, which is also used to determine risk for breast cancer.

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