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Regulatory perspectives on next-generation sequencing and complementary diagnostics in Japan
Rumiko Shimazawa1, Masayuki Ikeda2
1Department of Clinical Pharmacology, Tokai University School of Medicine , Isehara, Japan.
Expert Review of Molecular Diagnostics
|February 18, 2020
Summary
Next-generation sequencing (NGS) offers comprehensive cancer gene analysis, advancing personalized medicine. Japan
Area of Science:
- Oncology
- Genomics
- Regulatory Science
Background:
- The 'one biomarker/one drug' approach is insufficient for complex cancers.
- Next-generation sequencing (NGS) has become more accessible and efficient.
- NGS enables simultaneous analysis of multiple cancer genes for actionable mutations.
Purpose of the Study:
- To review recent regulations on NGS and complementary diagnostics in Japan.
- To highlight changes in regulation and the translation of NGS into clinical practice.
- To discuss the challenges and future directions of NGS implementation in Japan.
Main Methods:
- Review of recent regulations on NGS and complementary diagnostics in Japan.
- Focus on high-quality studies utilizing NGS published within the last five years.
- Analysis of regulatory changes and clinical translation efforts.
Main Results:
- NGS offers advantages over conventional diagnostics for comprehensive genomic profiling.
- Technological advancements and regulatory changes are driving NGS adoption in clinical practice.
- NGS-based genomic data enhance understanding of disease characteristics and therapy response.
Conclusions:
- NGS is rapidly being integrated into clinical practice in Japan.
- Translating NGS results into clinical benefits requires managing complex genomic data.
- Japanese authorities face challenges in managing NGS data for patient benefit.
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