NEW YORK – Japan's Ministry of Health, Labor and Welfare has approved Myriad Genetics' BRACAnalysis Diagnostic System for identifying breast cancer patients with germline BRCA1 and BRCA2 mutations.
The approval allows physicians in Japan to order BRACAnalysis for women with breast cancer who meet certain criteria established by the Japanese Organization of Hereditary Breast and Ovarian Cancer (JBHBOC). Patients who test positive for a deleterious BRCA1/2 mutation may then be recommended for prophylactic surgeries or targeted treatments.
Myriad will work with commercial partners in Japan to make the test available to patients.
Japanese regulators have previously approved BRACAnalysis for two other indications. Earlier this year, regulators approved it as a companion diagnostic for the ovarian cancer drug olaparib (AstraZeneca's Lynparza) and last year as a companion test for the same drug for patients with advanced breast cancer. In conjunction with the companion diagnostic approval, Myriad said it would partner with Miraca Group subsidiary SRL, a large laboratory services provider in Japan, to commercialize the test in the country.