NEW YORK (GenomeWeb) – Foundation Medicine said today that it has partnered with Chugai Pharmaceutical, a member of the Roche Group, to broaden patient access to its cancer genomic profiling services in Japan.
Under the collaboration, Chugai has already filed for regulatory approval of FoundationOne CDx, Foundation Medicine's comprehensive genomic profiling assay for all solid tumors that incorporates multiple companion diagnostics, with Japan's Ministry of Health, Labor, and Welfare (MHLW). If FoundationOne CDx is approved in Japan, Chugai will be the marketing authorization holder for the assay. In addition, Chugai will lead commercial efforts in Japan for all of Foundation Medicine's cancer profiling assays.
According to Melanie Nallicheri, chief business officer and head of biopharma at Foundation, MHLW approval of FoundationOne CDx "could enable the same accelerated pathway for companion diagnostic development and approval that Foundation Medicine has pioneered in the United States with [Food and Drug Administration] approval, meeting a critical need today for our biopharma partners' global development and commercial efforts. We look forward to partnering with Chugai, and our biopharma partners, to expand MHLW-approved companion diagnostics claims on FoundationOne CDx ensuring patient access to personalized cancer care."
Foundation Medicine received approval for FoundationOne CDx as a broad companion diagnostic and as a tumor mutation profiling assay for patients with solid tumors from the FDA last November, along with a preliminary national coverage determination from the Centers for Medicare and Medicaid Services.
"This collaboration further enables us to pursue personalized oncology care in Japan," said Chugai President and COO Tatsuro Kosaka in a statement.
According to Foundation Medicine, Japan represents the fourth-largest addressable market for next-generation sequencing in oncology after the US, China, and Germany.