Category
Standard
Type
Standard
Version
1
Access
Open
Status
Active
Created
2017
This is the current version.
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
By accessing this content, you are leaving this website. The Agency takes no responsibility for the accuracy of content on the destination page.