MPs urge Government to review regulations for direct-to-consumer genetic testing

• Read the report summary
• Read the conclusions and recommendations
• Read the full report: Direct-to-consumer genomic testing [PDF 1.18 KB]
• Science and Technology Committee

Drawing on evidence taken from genomic testing companies, healthcare professionals and think tanks, the Committee's Report makes a number of recommendations for the Government to consider when updating regulations, including:

• Pre-market assessment of direct-to-consumer tests by an independent body. This assessment should cover the test's clinical performance (the extent to which it can provide information about treatment of a disease, and the likelihood of improved outcomes) in addition to the current requirement to achieve analytical performance, which describes how well the test can identify the presence of a particular gene.
• The development of technical standards for direct-to-consumer genomic testing, enabling the data generated to be used and relied upon by Genomics England and the NHS. Clearly defining such standards would facilitate research efforts and reduce the burden placed on the NHS to re-test patients following testing via commercially obtained tests. It would also enable consumers to differentiate high quality, trustworthy products from those with lower standards.
• Considering whether to revise regulation regarding the advice and support offered when supplying genomic testing directly to customers. This could, for example, include a requirement for provision of genetic counselling depending on the severity of the condition being tested, and stipulate the predictive power of the test alongside results.
• Reconsideration of the guidance on the use of genomic testing on asymptomatic children. After hearing evidence from the Nuffield Council of Bioethics and researchers in the field, the Committee note concerns about testing being used inappropriately on children who cannot give informed consent.
• The Government should review the adequacy of the UK’s data protection framework for direct-to-consumer genomic testing, including the risks and opportunities presented by technological developments and growing numbers of consumers using direct-to-consumer genomic tests.

Chair of the Science and Technology Committee, Rt Hon Greg Clark MP, said:

"For thousands of people, at-home genomic testing has opened the door to a wealth of new information about our ancestry, our health and even the likelihood of disease. Done properly, genomic testing offers great potential for individual knowledge and can provide data which can advance medical research.

"However, these technologies can give rise to questions of quality, which are difficult for consumers to assess, and can sometimes pose challenging ethical questions. The Government has committed to a 'gold standard' for ethical and regulatory standards for genomics in the UK. In our Committee’s Report we set out perspectives we heard on the issues the Government should be considering as it devises a new regulatory framework."

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