ISO/NP TS 20738.2

Genomics Informatics — Requirement of data analysis for direct to consumer testing

Scope

This document specifies detection SNP site and evaluation metrics for direct-to-consumer detection.
This document specifies the requirement for the database that used for direct-to-consumer detection.
This document specifies the elements of assessment reports.
This document provides data analysis process requirements for genotyping arrays and genome sequencing.
This document applies to the analysis of genetic data for direct-to-consumer in vitro diagnostics products without the involvement of a health care provider.