Category
Standard
Type
Standard
Version
1
Access
Open
Status
Active
Created
2017
This document outlines the minimum best-practice requirements for medical pathology laboratories that conduct human genetic testing using massively parallel sequencing - also known as next-generation sequencing. This applies to all applications, including single gene, panel of genes, somatic testing, whole exome, whole genome and non-invasive prenatal testing. It takes a risk-based approach to defining standards for implementing these new technologies.
Main sections:
- Ethical issues and clinical governance
- Personnel
- Laboratory scope of testing
- Wet laboratory procedures
- IT infrastructure
- Bioinformatics
- Quality control and quality assurance
- Extension of classification of human genetic tests (normative)
- Key requirements of a genomic report (informative)
Main sections:
- Ethical issues and clinical governance
- Personnel
- Laboratory scope of testing
- Wet laboratory procedures
- IT infrastructure
- Bioinformatics
- Quality control and quality assurance
- Extension of classification of human genetic tests (normative)
- Key requirements of a genomic report (informative)
Access Requirements for human medical genome testing utilising massively parallel sequencing technologies
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