Commercial genomics

Science, Innovation and Technology Committee Closed Inquiry
Opened: 9 Apr 2020 Closed: 19 Nov 2021 Parliament page
Genomic testing seeks to offer health benefits and can provide other useful services. However, some have raised concerns regarding the potential risks associated with genomic tests being made directly available to consumers, including on the tests’ reliability and accuracy, the support available to consumers for understanding and acting on results, … Read more
16 Recommendations
1 Conclusion
1 Report
1 Oral session
4 Letters
1 Event
Activity timeline 8 events
1 Nov
2021
Report published
22 Jun
2021
Report published
17 Jun
2020
Oral evidence
17 Jun
2020
Formal meeting (oral evidence session) · The Wilson Room, Portcullis House
21 May
2020
Correspondence
21 May
2020
Correspondence
21 May
2020
Correspondence
21 May
2020
Correspondence
Oral evidence sessions 1 session
17 Jun 2020
View on parliament.uk
Oral Evidence
Dr Tara Clancy · Nuffield Council on Bioethics Graeme Tunbridge · Medicines and Healthcare products Regulatory Agency Professor Sir Mark Caufield · Genomics England The Lord Bethell · Department for Health and Social Care
Title HC No. Published Items Response
First Report - Direct-to-consumer genomic testing HC 94 22 Jun 2021 17 Responded
Recommendations & Conclusions
17 results
1 Recommendation
First Report - Direct-to-consumer …
A range of benefits and concerns have been raised regarding the availability of genomic testing...
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 … Read more
Department for Science, Innovation and Technology
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2 Recommendation
First Report - Direct-to-consumer …
Strong support for genomic testing from the current and previous Governments has helped to make...
Strong support for genomic testing from the current and previous Governments has helped to make the UK a world-leader in the sector. Although this support has focused on testing in the NHS, it has nonetheless supported the direct-to-consumer genomic testing … Read more
Department for Science, Innovation and Technology
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3 Recommendation
First Report - Direct-to-consumer …
Most manufacturers of genomic tests sold directly to consumers can self-certify the conformity of their...
Most manufacturers of genomic tests sold directly to consumers can self-certify the conformity of their products to performance requirements. The Medicines and Healthcare products Regulatory Agency has suggested that this restricts its ability to ensure that genomic tests on the … Read more
Department for Science, Innovation and Technology
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4 Recommendation
First Report - Direct-to-consumer …
The results obtained from genomic tests provided directly to consumers cannot be integrated into Genomics...
The results obtained from genomic tests provided directly to consumers cannot be integrated into Genomics England or NHS records since they do not always meet the standards required of the end-to-end testing and data handling process. Enabling tests that are … Read more
Department for Science, Innovation and Technology
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5 Recommendation
First Report - Direct-to-consumer …
The performance requirements on direct-to-consumer genomic tests under the current regulations focus on a genomic...
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 … Read more
Department for Science, Innovation and Technology
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6 Recommendation
First Report - Direct-to-consumer …
As the evidence base for genomic testing develops rapidly, some have expressed criticism of the...
As the evidence base for genomic testing develops rapidly, some have expressed criticism of the evidence used by some direct-to-consumer genomic testing companies to justify their tests, or warned of the risk of companies ‘cherry picking’ the most favourable evidence … Read more
Department for Science, Innovation and Technology
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7 Recommendation
First Report - Direct-to-consumer …
Results obtained from genomic testing must typically be considered in the context of an individual’s...
Results obtained from genomic testing must typically be considered in the context of an individual’s specific circumstance—including their symptoms, personal and family medical history and ethnicity—in order for the clinical significance of those results to be interpreted correctly. These personal … Read more
Department for Science, Innovation and Technology
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8 Recommendation
First Report - Direct-to-consumer …
Several contributors to this inquiry expressed concern that the information provided to consumers before and...
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 … Read more
Department for Science, Innovation and Technology
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9 Recommendation
First Report - Direct-to-consumer …
Building on its review of advertising for non-invasive prenatal testing, the Advertising Standards Authority should...
Building on its review of advertising for non-invasive prenatal testing, the Advertising Standards Authority should review, within the next year, the marketing materials used by companies offering other genomic tests directly to consumers, focusing in particular on the clinical performance … Read more
Department for Science, Innovation and Technology
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10 Conclusion
First Report - Direct-to-consumer …
The potential for results from non-invasive prenatal testing to influence decisions made on terminating pregnancies...
The potential for results from non-invasive prenatal testing to influence decisions made on terminating pregnancies raises specific issues not encountered by most other genomic tests offered to consumers. Several submissions highlighted the importance of the information and other support provided … Read more
Government Response
This issue is addressed in MHRA’s consultation, as the information provided alongside such tests is a crucial part of their regulation. There may be a role for the UK National … Read more
Department for Science, Innovation and Technology
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11 Recommendation
First Report - Direct-to-consumer …
Many submissions to this inquiry expressed concern that direct-to-consumer genomic testing could increase pressure on...
Many submissions to this inquiry expressed concern that direct-to-consumer genomic testing could increase pressure on the NHS due to consumers consulting their GP following a test result. Although there is not yet strong evidence of this happening, some companies providing … Read more
Department for Science, Innovation and Technology
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12 Recommendation
First Report - Direct-to-consumer …
Concern was raised with us that companies providing genomic tests directly to consumers could profit...
Concern was raised with us that companies providing genomic tests directly to consumers could profit from supplying the tests while leaving the NHS to deal with consumers and their results following the test. Addressing this issue, representatives of several major … Read more
Department for Science, Innovation and Technology
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13 Recommendation
First Report - Direct-to-consumer …
Various concerns related to privacy and consent regarding data generated by direct- to-consumer genomic tests...
Various concerns related to privacy and consent regarding data generated by direct- to-consumer genomic tests were raised during this inquiry. Many of these were similar to concerns that have been expressed regarding personal data more generally, although the relevance of … Read more
Department for Science, Innovation and Technology
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14 Recommendation
First Report - Direct-to-consumer …
Although there is potential for the results of a genomic test to be upsetting, this...
Although there is potential for the results of a genomic test to be upsetting, this is not a sufficient reason to prevent consenting adults from using these tests. However, a range of submissions to our inquiry and our predecessor Committee’s … Read more
Department for Science, Innovation and Technology
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15 Recommendation
First Report - Direct-to-consumer …
Prenatal genomic testing could influence decisions on terminating fetuses, leading to specific concerns in addition...
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 … Read more
Department for Science, Innovation and Technology
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16 Recommendation
First Report - Direct-to-consumer …
The Government should consider requiring any manufacturer making genomic tests available to consumers in the...
The Government should consider requiring any manufacturer making genomic tests available to consumers in the UK to register a legal representative in the UK, with responsibility for ensuring that products supplied to consumers in the UK meet all relevant UK … Read more
Department for Science, Innovation and Technology
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17 Recommendation
First Report - Direct-to-consumer …
As well as companies offering products to consumers that combine genomic testing with analysis of...
As well as companies offering products to consumers that combine genomic testing with analysis of the genomic data obtained through the test, some companies offer secondary analysis of genomic data obtained through a previous genomic test from a different company. … Read more
Department for Science, Innovation and Technology
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Correspondence 4 letters
21 May 2020 Correspondence from • Avi Lasarow, Chief Executive Officer, DNAfit, relating to Commercial genomics follow-up
Parliament page
21 May 2020 Correspondence from • Baroness Blackwood, Parliamentary Under-Secretary of State for Innovation (Lords) to the Committee relating to Commercial Genomics
Parliament page
21 May 2020 Correspondence from • Carla Newell, Chief Legal Officer, Ancestry, relating to Commercial genomics follow-up
Parliament page
21 May 2020 Correspondence from Kathy Hibbs, Chief Legal and Regulatory Officer, 23andMe, relating to Commercial genomics follow-up
Parliament page