Regulatory perspectives on next-generation sequencing and complementary diagnostics in Japan.
Expert Rev Mol Diagn
; 20(6): 601-610, 2020 06.
Article
em En
| MEDLINE
| ID: mdl-32064968
ABSTRACT
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 high-quality studies that utilized these new diagnostic modalities and were published within the last 5 years. We highlight significant changes in regulation, and explain the direction of efforts to translate the results of NGS and complementary diagnostics into clinical practice. EXPERT OPINION NGS holds a number of advantages over conventional companion and complementary diagnostics that enable simultaneous analyzes of multiple cancer genes to detect actionable mutations. Parallel technological developments and regulatory changes have led to the rapid adoption of NGS into clinical practice. NGS-based genomic data have been leveraged to better understand the characteristics of a disease that affects its patient's response to a given therapy. As NGS-based tests become more widespread, however, Japanese authorities will face significant challenges particularly with respect to the complexity of genomic data, which will have to be managed if NGS is to benefit patients.Palavras-chave
Texto completo:
1
Temas:
ECOS
/
Aspectos_gerais
/
Estado_mercado_regulacao
Bases de dados:
MEDLINE
Assunto principal:
Técnicas de Diagnóstico Molecular
/
Medicina de Precisão
/
Sequenciamento de Nucleotídeos em Larga Escala
/
Legislação de Dispositivos Médicos
/
Neoplasias
Tipo de estudo:
Diagnostic_studies
/
Prognostic_studies
País/Região como assunto:
Asia
Idioma:
En
Revista:
Expert Rev Mol Diagn
Assunto da revista:
BIOLOGIA MOLECULAR
Ano de publicação:
2020
Tipo de documento:
Article
País de afiliação:
Japão