Source · Select Committees · Science, Innovation and Technology Committee
Recommendation 6
6
Deferred
Paragraph: 53
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.
Government response summary AI-generated
The government states that MHRA's public consultation is exploring pre-market requirements for devices, implying that this process will inform future policy on this matter.
Summary of the government's response below — read the verbatim text to verify.
Paragraph Reference:
53
Government Response
Deferred
HM Government · verbatim extract
Deferred
MHRA’s public consultation explores the pre-market requirements for devices placed on the UK market.
Read the full response on Parliament ↗