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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
HM Government Acknowledged
MHRA’s public consultation explores the pre-market requirements for devices placed on the UK market.
Addressee Bodies
Department for Science, Innovation and Technology
Timeline
Recommendation age 4.9 yrs
Report published 22 Jun 2021