April 5, 2018 — Myriad Genetic Laboratories Inc. announced that the Japanese Ministry of Health, Labour and Welfare has granted manufacturing and marketing approval for Myriad’s BRACAnalysis Diagnostic System to be used as a companion diagnostic with the PARP inhibitor, Lynparza. Lynparza is marketed by AstraZeneca and Merck, known as MSD outside the United States and Canada.
AstraZeneca and Merck are seeking approval of Lynparza in Japan for treating patients with BRCA-mutated metastatic breast cancer. BRACAnalysis is the first and only diagnostic test for a PARP inhibitor to receive regulatory approval in Japan. The test is marketed in the United States as BRCAnalysis CDx.
Currently there are about 40,000 patients with metastatic disease that would be eligible for BRACAnalysis testing in Japan, with an estimated 15,000 new cases of HER2-negative breast cancer diagnosed each year. Myriad will commercialize BRACAnalysis in exclusive partnership with the SRL Inc., a subsidiary of Miraca Group, and one of the largest laboratory service providers in Japan.
BRACAnalysis is a diagnostic system that classifies a patient’s clinically significant variants (DNA sequence variations) in the BRCA1 and BRCA2 genes. Variants are classified into one of the five categories — “Deleterious,” “Suspected Deleterious,” “Variant of Uncertain Significance,” “Favor Polymorphism” or “Polymorphism.” Once the classification is completed, the results are sent to medical personnel in Japan for determining the eligibility of patients for treatment with Lynparza.
BRACAnalysis CDx was approved by the U.S. Food and Drug Administration (FDA) in December 2014 for patients with advanced ovarian cancer, and again in January 2018 for patients with HER2-negative metastatic breast cancer.
For more information: www.myriad.com