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
- The Japan Lung Cancer Society proposed that CDx products for detection of 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 a 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, Janan
December 2023