NEW YORK – Myriad Genetics said Monday that it has submitted a supplementary application to the Japanese Ministry of Health Labor and Welfare for use of its BRACAnalysis Diagnostic System as a companion diagnostic to identify patients with metastatic pancreatic or metastatic castration-resistant prostate cancer who have germline BRCA1 and BRCA2 mutations and may be candidates for targeted therapy with the PARP inhibitor olaparib (AstraZeneca's Lynparza), subject to regulatory approval.
BRACAnalysis classifies a patient’s clinically significant germline DNA sequence variations in the BRCA1 and BRCA2 genes.
The BRACAnalysis Diagnostic System was previously approved in Japan to identify patients with ovarian or breast cancer who have a germline BRCA mutation and are eligible for Lynparza therapy. BRACAnalysis is the only germline test for BRCA1 and BRCA2 mutations to receive regulatory approval in Japan, Myriad noted.
"Today’s regulatory filing potentially will expand the approved indications for BRACAnalysis as a companion diagnostic test in Japan," Gary King, executive VP of international operations at Myriad, said in a statement.
Salt Lake City, Utah-based Myriad has partnered with Shinjuku-Ku, Japan-based SRL, a subsidiary of Miraca Group, to commercialize the BRACAnalysis Diagnostic System in Japan.
Lynparza is marketed by Cambridge, UK-based AstraZeneca and Kenilworth, New Jersey-based MSD, also known as Merck in the US and Canada.
Myriad estimates there are more than 78,000 cases of prostate cancer and 40,000 cases of pancreatic cancer per year in Japan.