15
Prenatal genomic testing could influence decisions on terminating fetuses, leading to specific concerns in addition...
Recommendation
Prenatal genomic testing could influence decisions on terminating fetuses, leading to specific concerns in addition to the issues concerning other types of direct-to- consumer genomic testing. The Government should consider if any restrictions should be placed on the conditions that prenatal genomic tests provided directly to consumers are able to test for. (Paragraph 99) 54 Direct-to-consumer genomic testing
Government Response
Acknowledged
Government Response
Acknowledged
HM Government
Acknowledged
Under the UK Medical Device Regulations 2002, the MHRA could only take action against the use of certain genomic tests if a compliance or safety issue associated with the device had arisen. The MHRA proactively investigate and review adverse incident reports for all medical devices placed onto the UK market and take necessary regulatory action where needed. The UKNSC is keen to be involved in any future discussions with MHRA to advise on policy relating to recommendation 14. The Government will encourage and facilitate these discussions where appropriate.
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