NEW YORK – Myriad Genetics' BRACAnalysis Diagnostic System will be reimbursed in Japan as a test to identify whether individuals with hereditary breast and ovarian cancer syndrome have BRCA1/2 mutations.
Japan's Ministry of Health, Labor and Welfare (MHLW) granted regulatory approval for the diagnostic in November of last year for this indication. In February 2019, the MHLW approved the test as a companion diagnostic for the PARP inhibitor olaparib (AstraZeneca's Lynparza) in ovarian cancer, and in March 2018, it approved it as a companion diagnostic for the same drug in metastatic inoperable or recurrent breast cancer.
The most recent reimbursement decision means the test will be covered when physicians order it for patients who meet the following criteria from the Japanese Organization of Hereditary Breast and Ovarian Cancer: their family members have BRCA1/2 mutations; they have certain personal or family history of breast cancer, ovarian cancer, or male breast cancer; or somatic testing reveals they may have BRCA1/2 mutation and they are eligible for a PARP inhibitor.
Myriad estimates there are more than 25,000 people who meet this testing criteria in Japan, where it has partnered with SRL, a subsidiary of Miraca Group, to commercialize BRACAnalysis.