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Myriad Genetics Submits BRACAnalysis CDx for Approval in Japan

NEW YORK (GenomeWeb) – Myriad Genetics has submitted BRACAnalysis CDx for review by Japan's Pharmaceutical Medical Devices Agency and for marketing approval by its Ministry of Health, Labor and Welfare.

If approved, the companion diagnostic can be used to identify which HER2-negative, metastatic breast cancer patients have germline mutations in BRCA1 and BRCA2 genes and are likely to respond to AstraZeneca's Lynparza (olaparib).

"This regulatory submission as a companion diagnostic for a PARP inhibitor outside the US reflects another important major milestone as Myriad seeks to become a global leader in personalized medicine,” Myriad CEO Mark Capone said in a statement.

Myriad will perform testing for the Japanese market in its US lab. The company estimated that in Japan each year there are more than 10,000 cases of HER2-negative metastatic breast cancer eligible for testing with BRACAnalysis CDx.

Earlier this month, the company said that the US Food and Drug Administration had accepted its supplementary premarket approval application for BRACAnalysis CDx alongside Lynparza in the same breast cancer setting. The test is already approved as a CDx for Lynparza for patients with germline BRCA-mutated advanced ovarian cancer, who have received three or more prior lines of chemotherapy.