NEW YORK – Myriad Genetics said Friday that Japan's Ministry of Health, Labor, and Welfare has granted expanded coverage for the firm's BRACAnalysis test as a companion diagnostic to identify patients with early-stage, germline BRCA-mutated and HER2-negative high-risk breast cancer who may benefit from adjuvant treatment with AstraZeneca and Merck's Lynparza (olaparib).
"With this expanded coverage, more patients with breast cancer now qualify for BRCA1/2 testing in Japan," Myriad's Japan Country Manager Shunsuke Kuraoka said in a statement.
The company pointed to emerging evidence from the OlympiA Phase III trial as pivotal in supporting its reimbursement progress. The study, which concluded that Lynparza improved invasive, disease-free survival and overall survival versus placebo, has also supported approvals of the drug in the US and Europe.
Myriad's BRACAnalysis diagnostic system is designed to detect deleterious germline BRCA1 and BRCA2 variants in patients with HER2-negative, high-risk, early breast cancer, and the firm's companion diagnostic partnership with AstraZeneca has led to multiple prior approvals across different cancer types and indications.