Regulatory perspectives on next-generation sequencing and complementary diagnostics in Japan.

doi:10.1080/14737159.2020.1728256

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Article

Regulatory perspectives on next-generation sequencing and complementary diagnostics in Japan.

Expert review of molecular diagnostics - 1 Jun 2020

Shimazawa Rumiko, Ikeda Masayuki

Abstract excerpt

INTRODUCTION: The 'one biomarker/one drug' scenario is unsustainable because cancer is a complex disorder that involves a number of molecular defects. In the past decade, major technological advances have lowered the overall cost and increased the efficiency of next-generation sequencing (NGS). AREAS COVERED: We review recent regulations on NGS and complementary diagnostics in Japan, mainly focusing on...

Topics

B7-H1 Antigen
Carcinoma, Non-Small-Cell Lung
DNA Mutational Analysis
Databases, Nucleic Acid
Device Approval
Direct-To-Consumer Screening and Testing
Drug Resistance, Microbial
Equipment and Supplies
Genetic Diseases, Inborn
Government Agencies

Methodology Data sources Editorial policy Privacy About Contact Helena Bioinformatics

Health Services Needs and Demand

High-Throughput Nucleotide Sequencing

Humans

Immune Checkpoint Inhibitors

Japan

Lung Neoplasms

Medical Device Legislation

Molecular Diagnostic Techniques

Source

Open in PubMed

Identifiers

PMID: 32064968
DOI: 10.1080/14737159.2020.1728256

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