The purpose of this WG is to discuss regulatory issues related to Companion Diagnostics (CDx) and a corresponding therapeutic product. The WG contributes to the development of relevant notifications and administrative notices issued by MHLW.
（Activity period: From April, 2012）
Activities
Dissemination of Information related to CDx
Dissemination of Information related to Drug-Agnostic CDx
- Evaluation report on the applicability of Drug-Agnostic CDx and a list of therapeutic products for which eligible patients can be identified using Drug-Agnostic CDx.
- The Japanese Society of Medical Oncology and the Japanese Society for Cancer of the Colon and Rectum proposed that CDx products for detecting deficiencies in mismatch-repair function be used in a drug-agnostic manner (January 13, 2026).
- The Japan Lung Cancer Society proposed that CDx products for detecting EGFR gene mutations in non-small cell lung cancer tissues be used in a drug-agnostic manner (May 2, 2023). Based on the proposal, we prepared an Evaluation Report on Applicability (August 29, 2025).
（Note） Refer to “2. Related Notification”.
The activities conducted over the last five years.
Presentations
Quality Control of Software as a Medical Device for Genomic TestingThe 11th Symposium on the Industry-Government-Academia Collaborative Forefront Cancer Genome, Tokyo, Japan, December 2023