Foundation Medicine, Inc. today announced that Japan’s regulatory agency, the Ministry of Health, Labour and Welfare (MHLW) has approved FoundationOne CDx as a comprehensive genomic profiling test for all solid tumors and a broad companion diagnostic for individuals living with advanced cancer. Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) is the Marketing Authorization Holder of FoundationOne CDx in Japan.
“The approval of FoundationOne CDx in Japan is yet another testament to its validation and is critical to enabling patient access to comprehensive genomic profiling,” said Melanie Nallicheri, chief business officer and head of biopharma at Foundation Medicine. “Similar to our FDA approval in the United States, the MHLW has approved FoundationOne CDx as a comprehensive genomic profiling tool for all solid tumors and a broad companion diagnostic, a first of its kind comprehensive diagnostic test for individuals living with cancer in Japan. This is also an important milestone for our biopharma partners who can leverage FoundationOne CDx to accelerate companion diagnostic development and improve access to personalized oncology care in Japan.”
The MHLW is expected to issue a reimbursement coverage decision in the first half of 2019. The coverage decision for FoundationOne CDx is expected to improve access to MHLW-approved targeted therapies and immunotherapies, as well as clinical trials, for patients with cancer.
“This breakthrough approval of FoundationOne CDx establishes validation for this test which is an essential step to making it available to patients in Japan,” said Tatsuro Kosaka, Chugai’s president and chief executive officer. “We are excited to make FoundationOne CDx broadly available and improve patient access to approved therapies and clinical trials.”