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A range of benefits and concerns have been raised regarding the availability of genomic testing...

Recommendation
A range of benefits and concerns have been raised regarding the availability of genomic testing for direct purchase and use by consumers. These apply to all types of genomic tests, but are arguably most acute for tests used for medically-related purposes. Despite concerns around direct-to-consumer tests existing for many years, evidence of harm has mostly not been systematically collected and is limited. As direct-to-consumer genomic testing becomes more widespread and covers a greater variety of conditions, evidence of positive impacts and harms may grow. We have heard calls for updated regulation of direct-to-consumer genomic testing. While the Government has acknowledged the importance of maintaining public trust in genomics and said that it would “establish a gold standard UK model for how to apply strong and consistent ethical and regulatory standards”, it has committed only to consulting on and publishing future regulations for Great Britain at a “later date”. The Government should set out a specific timeframe in which it intends to review the case for introducing new regulations for genomic tests provided directly to consumers (‘direct-to-consumer genomic tests’). (Paragraph 34) Supporting a responsible direct-to-consumer genomic testing industry
Government Response
Acknowledged
HM Government Acknowledged
The Government recognises both the opportunities and risks raised by direct-to-consumer genomic tests and is committed to ensuring effective and proportionate regulation. The MHRA is working to develop a robust, world-leading regulatory regime for medical devices that prioritises patient safety. The MHRA launched a public consultation on the 16 September 2021 into the regulation of IVDs, which covers DTC genomic tests, and new regulations are planned to follow in summer 2022. The consultation explores several matters raised in the Committee’s report and will be open for ten weeks. The Government is therefore unable to provide a detailed response to many of the report’s recommendations until the consultation has completed and the results have been analysed.
Addressee Bodies
Department for Science, Innovation and Technology
Timeline
Recommendation age 4.9 yrs
Report published 22 Jun 2021