Session Details

[S03☆]Innovation, Regulation, and Communication in Health and Medical Diagnostic Technologies

Fri. Mar 27, 2026 9:30 AM - 11:30 AM JST
Fri. Mar 27, 2026 12:30 AM - 2:30 AM UTC
Room 07 (F403, Bldg. 4, Area 2 [4F])
Organizer: Masuo Kondoh (Grad. Sch. Sci., Osaka Univ.), Yoshinori Tsukumo (NIHS)
As is well known, in drug discovery research that begins with target identification, diagnostic technologies for detecting molecular targets are becoming increasingly important as part of the health and medical infrastructure. These technologies play key roles across the continuum of basic, non-clinical, and clinical research, as well as in patient stratification, precision medicine, and the appropriate use of pharmaceuticals through target verification and clinical validation. Recent advances in multi-omics analysis technologies utilizing next-generation sequencing (NGS) and mass spectrometry (MS) have further accelerated the sophistication of diagnostic technologies and the development of diagnostic markers across diverse modalities.
In light of these developments, this symposium will feature presentations by experts from the Ministry of Health, Labour and Welfare, who are responsible for the review of in vitro diagnostic pharmaceuticals, as well as researchers engaged in clinical development for cancer and dementia, studies on the intestinal microbiota, and regulatory science in diagnostic technology. Through discussions among representatives from industry, government, and academia, we aim to provide participants with an opportunity to gain insights into the forefront of diagnostic research and development.

Opening Remarks
Masuo Kondoh1(1. Grad. Sch. Pharm. Sci., U Osaka)

[S03-1]Regulatory Framework for In Vitro Diagnostic Medical Devices and the 2025 PMD Act Revision

○Mai Itagaki1 (1. Ministry of Health, Labour and Welfare)

[S03-2]Biomarker development for prevention of dementia based on understanding of pathomechanism

○Taisuke Tomita1 (1. Grad Sch Pharm Sci, U Tokyo)

[S03-3]Development of a rapid detection system for foodborne pathogens and gut microbes using a non-targeted antibody library generated by whole-bacteria immunization

○Jun Kunisawa1,2,3,4,5 (1. NIBN, 2. Univ of Osaka, 3. IMSUT, 4. Kobe Univ, 5. Waseda Univ)

[S03-4]Performance evaluation of nucleic acid amplification test kits in the early phase of emerging infectious disease outbreaks

○Takao Inoue1 (1. NIHS)

[S03-5]Clinical development of in vitro diagnostics in the fields of cancer and dementia

○Toshiyuki Sato1 (1. Central Research Laboratories, Sysmex Corporation)

Closing Remarks
Yoshinori Tsukumo1 (1. NIHS)