Myriad Genetics Gets CE Mark for BRCA 1/2 Tumor Test

Salt Lake City, Utah-based Myriad Genetics said Thursday it has received a CE mark for its Tumor BRACAnalysis CDx test, which detects inherited and acquired mutations in the BRCA 1 and 2 genes. The test is the first companion diagnostic authorized in Europe to identify patients who would benefit from treatment with a poly ADP-ribose polymerase inhibitor.

Patients with mutations of the BRCA1/2 genes are more likely to respond to DNA-damaging agents like PARP inhibitors, platinum-based drugs and other chemotherapeutic agents, Myriad spokesman Ron Rogers told Device Daily Bulletin.

The diagnostic will be paired with AstraZeneca’s Lynparza and other future PARP inhibitors, Myriad said. Last month, the European Medicines Agency approved Lynparza as a monotherapy for patients with BRCA-mutated ovarian, fallopian tube and primary peritoneal cancers who respond well to platinum-based chemotherapy.

In clinical studies, the Tumor BRACAnalysis CDx detected up to 44 percent more patients who are candidates for PARP therapy compared with conventional BRCA testing, according to Myriad. Results are provided in 14 days. 

Myriad is collaborating with a number of U.S. pharma companies on pairings of drugs with its companion diagnostic, including AbbVie. In December, the company received FDA approval of the BRACAnalysis CDx blood test, a germline companion diagnostic used with Lynparza in ovarian cancer patients, Rogers said. — Kellen Owings