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The performance requirements on direct-to-consumer genomic tests under the current regulations focus on a genomic...
Recommendation
The performance requirements on direct-to-consumer genomic tests under the current regulations focus on a genomic test’s analytical performance, not its clinical performance. For a medically-relevant test, however, clinical performance is fundamental to how the test will be used by a consumer. The Government should extend the scope of the performance requirements on direct-to-consumer genomic tests to explicitly cover clinical performance as well as analytical performance.
Paragraph Reference
47
Government Response
Acknowledged
Government Response
Acknowledged
HM Government
Acknowledged
Performance requirements for IVDs, including DTC genomic tests, are explored as part of MHRA’s public consultation and will help to inform future policy related to this recommendation. The National Institute for Health Care Excellence (NICE) are also exploring the development of rapid, straightforward, trusted advice on important diagnostic, and digital technologies, such as at-home diagnostic tests which are directly accessible to patients/ consumers. The Government encourages other well-placed partners, such as the independent UK National Screening Committee (UKNSC), to share their expertise with the MHRA on the validity and utility of DTC genomic tests, given that they have experience working with academic experts on the assessment of the validity and utility of other types of medical tests. Government will keep this recommendation under review following the outcome of MHRA’s consultation and will facilitate discussions between MHRA, NICE and the UKNSC, 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