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Several contributors to this inquiry expressed concern that the information provided to consumers before and...

Recommendation
Several contributors to this inquiry expressed concern that the information provided to consumers before and after using a direct-to-consumer genomic test, as well as the advertising used to market direct-to-consumer genomic tests, did not do enough to address public misconceptions of the capability of these tests and clarify the clinical utility of the results generated. Even where advertising material has used statistics accurately, the Advertising Standards Authority has ruled that there is still scope for them to provide a misleading impression to consumers. The Government should consider the case for including reviews of the information provided to consumers 52 Direct-to-consumer genomic testing prior to and after taking a direct-to-consumer test within any external validation required to place such tests on the market. This could, for example, include assessment of studies of consumer understanding of the information provided.
Paragraph Reference
71
Government Response
Acknowledged
HM Government Acknowledged
Several areas being explored as part of MHRA’s public consultation, including the potential to introduce new classification rules for IVDs, will help to inform future policy on this recommendation.
Addressee Bodies
Department for Science, Innovation and Technology
Timeline
Recommendation age 4.9 yrs
Report published 22 Jun 2021