www.fdanews.com/articles/193575-japan-clears-myriads-breast-cancer-diagnostic
Japan Clears Myriad’s Breast Cancer Diagnostic
November 25, 2019
Myriad Genetics received approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for its BRACAnalysis diagnostic system for detecting hereditary breast and ovarian cancer (HBOC) syndrome in women.
The genetic test, which identifies germline mutations in the BRCA1/2 genes, tests for BRCA mutations in female breast cancer patients that meet Japan’s genetic testing guidelines.
“Patients who test positive for a deleterious BRCA mutation will be eligible to receive advanced medical management, such as prophylactic surgery or targeted therapies,” the company said.