Good Laboratory Standards for Clinical Next-Generation Sequencing Cancer Panel Tests
Journal of Pathology and Translational Medicine
; : 191-204, 2017.
Article
em En
| WPRIM
| ID: wpr-38104
Biblioteca responsável:
WPRO
ABSTRACT
Next-generation sequencing (NGS) has recently emerged as an essential component of personalized cancer medicine due to its high throughput and low per-base cost. However, no sufficient guidelines for implementing NGS as a clinical molecular pathology test are established in Korea. To ensure clinical grade quality without inhibiting adoption of NGS, a taskforce team assembled by the Korean Society of Pathologists developed laboratory guidelines for NGS cancer panel testing procedures and requirements for clinical implementation of NGS. This consensus standard proposal consists of two parts: laboratory guidelines and requirements for clinical NGS laboratories. The laboratory guidelines part addressed several important issues across multistep NGS cancer panel tests including choice of gene panel and platform, sample handling, nucleic acid management, sample identity tracking, library preparation, sequencing, analysis and reporting. Requirements for clinical NGS tests were summarized in terms of documentation, validation, quality management, and other required written policies. Together with appropriate pathologist training and international laboratory standards, these laboratory standards would help molecular pathology laboratories to successfully implement NGS cancer panel tests in clinic. In this way, the oncology community would be able to help patients to benefit more from personalized cancer medicine.
Palavras-chave
Texto completo:
1
Base de dados:
WPRIM
Assunto principal:
Controle de Qualidade
/
Guias de Prática Clínica como Assunto
/
Consenso
/
Patologia Molecular
/
Sequenciamento de Nucleotídeos em Larga Escala
/
Coreia (Geográfico)
Tipo de estudo:
Diagnostic_studies
/
Guideline
Limite:
Humans
País/Região como assunto:
Asia
Idioma:
En
Revista:
Journal of Pathology and Translational Medicine
Ano de publicação:
2017
Tipo de documento:
Article