Source · Select Committees · Science, Innovation and Technology Committee
Recommendation 5
5
Deferred
Paragraph: 47
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.
Government response summary AI-generated
The government defers action, stating that performance requirements for such tests are part of an ongoing MHRA public consultation, the outcome of which will inform future policy. It will keep the recommendation under review following this consultation and facilitate discussions between relevant bodies.
Summary of the government's response below — read the verbatim text to verify.
Paragraph Reference:
47
Government Response
Deferred
HM Government · verbatim extract
Deferred
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.
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