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As the evidence base for genomic testing develops rapidly, some have expressed criticism of the...
Recommendation
As the evidence base for genomic testing develops rapidly, some have expressed criticism of the evidence used by some direct-to-consumer genomic testing companies to justify their tests, or warned of the risk of companies ‘cherry picking’ the most favourable evidence available. Requiring external validation of direct-to- consumer genomic tests, covering clinical as well as analytical performance, could help to address this. In addition to pre-market validation of direct-to-consumer tests, the Government should consider requiring companies offering such tests to regularly update the evidence submitted to the external validation body, and for that body to review this, for example on an annual basis.
Paragraph Reference
53
Government Response
Acknowledged
Government Response
Acknowledged
HM Government
Acknowledged
MHRA’s public consultation explores the pre-market requirements for devices placed on the UK market.
Source
Inquiry
Commercial genomics
Report
First Report - Direct-to-consumer genomic testing
22 Jun 2021
HC 94
Addressee Bodies
Department for Science, Innovation and Technology
Timeline
Recommendation age
4.9 yrs
Report published
22 Jun 2021