First Report - Direct-to-consumer genomic testing

Select Committee

Science, Innovation and Technology Committee HC 94 22 June 2021

Report Status Government responded

Conclusions & Recommendations 17 items (16 recs)

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Recommendations

16 results

1

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 … Read more

Department for Science, Innovation and Technology

2

Para 37

Strong support for genomic testing from the current and previous Governments has helped to make...

Recommendation

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

3

Para 41

Most manufacturers of genomic tests sold directly to consumers can self-certify the conformity of their...

Recommendation

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

4

Para 44

The results obtained from genomic tests provided directly to consumers cannot be integrated into Genomics...

Recommendation

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

5

Para 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 … Read more

Department for Science, Innovation and Technology

6

Para 53

As the evidence base for genomic testing develops rapidly, some have expressed criticism of the...

Recommendation

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

7

Para 64

Results obtained from genomic testing must typically be considered in the context of an individual’s...

Recommendation

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

8

Para 71

Several contributors to this inquiry expressed concern that the information provided to consumers before and...

Recommendation

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

9

Para 72

Building on its review of advertising for non-invasive prenatal testing, the Advertising Standards Authority should...

Recommendation

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

11

Para 79

Many submissions to this inquiry expressed concern that direct-to-consumer genomic testing could increase pressure on...

Recommendation

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

12

Para 82

Concern was raised with us that companies providing genomic tests directly to consumers could profit...

Recommendation

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

13

Para 88

Various concerns related to privacy and consent regarding data generated by direct- to-consumer genomic tests...

Recommendation

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

14

Para 95

Although there is potential for the results of a genomic test to be upsetting, this...

Recommendation

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

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 … Read more

Department for Science, Innovation and Technology

16

Para 101

The Government should consider requiring any manufacturer making genomic tests available to consumers in the...

Recommendation

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

17

As well as companies offering products to consumers that combine genomic testing with analysis of...

Recommendation

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

Conclusions (1) Observations and findings — click to expand

10 Conclusion

Para 76

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 to those receiving results from such tests to not only …