Myriad Genetics announced Thursday that Japan's Ministry of Health, Labour, and Welfare (MHLW) has granted expanded coverage for the firm’s BRACAnalysis Diagnostic System.
BRACAnalysis classifies a patient's clinically significant DNA sequence variations in the germline BRCA1 and BRCA2 genes.
MHLW has granted expanded coverage for the tool as a companion diagnostic to identify patients with germline BRCA-mutated (gBRCAm) and HER2-negative high-risk recurrent breast cancer who may benefit from Lynparza (olaparib).
Lynparza was jointly developed and commercialized by AstraZeneca and MSD.
The collaboration between Myriad Genetics and AstraZeneca on olaparib began in 2007, and has led to multiple approvals in the U.S. and Japan.