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Foundation Medicine Announces Regulatory Approval of FoundationOne®CDx in Japan

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.”

FoundationOne CDx is a next generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements known to drive cancer growth, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens. As approved by the MHLW, FoundationOne CDx is intended as a companion diagnostic to identify patients who may benefit from treatment with the targeted therapies listed below in accordance with their approved therapeutic product labeling in Japan.

  • EGFR exon 19 deletions and EGFR exon 21 L858R alterations, which may indicate efficacy of afatinib, erlotinib, gefitinib, osimertinib in patients with Non-Small Cell Lung Cancer (NSCLC)
  • EGFR exon 20 T790M alterations which may indicate efficacy of osimertinib in NSCLC patients
  • ALK rearrangements which may indicate efficacy of alectinib, ceritinib, or crizotinib in NSCLC patients
  • BRAF V600E and V600K which may indicate efficacy of dabrafenib, trametinib, vemurafenib in melanoma patients
  • ERBB2 (HER2) amplification which may indicate efficacy of trastuzumab in patients with breast cancer
  • KRAS wild-type / NRAS wild-type which may indicate efficacy of cetuximab and panitumumab in patients with colorectal cancer

About Foundation Medicine

Foundation Medicine is a molecular information company dedicated to a transformation in cancer care in which treatment is informed by a deep understanding of the genomic changes that contribute to each patient's unique cancer. The company offers a full suite of comprehensive genomic profiling assays to identify the molecular alterations in a patient's cancer and match them with relevant targeted therapies, immunotherapies and clinical trials. Foundation Medicine's molecular information platform aims to improve day-to-day care for patients by serving the needs of clinicians, academic researchers and drug developers to help advance the science of molecular medicine in cancer. For more information, please visit or follow Foundation Medicine on Twitter (@FoundationATCG).

About Chugai

Chugai Pharmaceutical is one of Japan's leading research-based pharmaceutical companies with strengths in biotechnology products. Chugai, based in Tokyo, specializes in prescription pharmaceuticals and is listed on the 1st section of the Tokyo Stock Exchange. As an important member of the Roche Group, Chugai is actively involved in R&D activities in Japan and abroad. Specifically, Chugai is working to develop innovative products which may satisfy unmet medical needs, mainly focusing on the oncology area.

In Japan, Chugai's research facilities in Gotemba and Kamakura are collaborating to develop new pharmaceuticals and laboratories in Ukima are conducting research for technology development for industrial production. Overseas, Chugai Pharmabody Research based in Singapore is engaged in research focusing on the generation of novel antibody drugs by utilizing Chugai's proprietary innovative antibody engineering technologies. Chugai Pharma USA and Chugai Pharma Europe are engaged in clinical development activities in the United States and Europe.

The consolidated revenue in 2017 of Chugai totaled 534.2 billion yen and the operating income was 103.2 billion yen (IFRS Core basis). Additional information is available on the internet at

Foundation Medicine ®  and FoundationOne ® are a registered trademarks of Foundation Medicine, Inc.

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Last Updated: 27-Dec-2018