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Policymakers advised to address problems with direct-to-consumer genomic testing

28 June 2021
Appeared in BioNews 1101

The UK Government should review regulation of direct-to-consumer genetic and genomic tests, according to a report by the House of Commons Science and Technology Committee.

The 'Direct-to-consumer genomic testing' report outlined the possible risks posed by the increasing availability and scope of consumer genetic and genomic testing. Such tests have become increasingly popular in recent years – by 2020 at-home testing company 23andMe had sold over 250,000 genetic testing kits in the UK, and as the cost of whole genome sequencing comes down more genomic tests are likely to be marketed. However, there are concerns that medical information gleaned from such tests can be misleading (see BioNews 1020).

'We recommend that the Government should require direct-to-consumer tests to be subject to greater pre-market assessment by an external body' said the report. 'We suggest that any such external assessment should cover the test's clinical performance (the extent to which a test can provide information about diagnosis, treatment, management or prevention of disease that will lead to an improved outcome), as well as its analytical performance (how well a test predicts the presence or absence of a particular gene or genetic change)'.

Further recommendations included the development of technical standards to allow such results to be integrated with NHS data, This could reduce the burden on the NHS from having to re-test individuals following consumer tests, but also allow commercial test results to support research. There are also recommendations around limiting some test types to professional use, and banning tests that would fall outside clinical guidelines such as testing children for late-onset conditions. 

The committee also specifically addressed that the Government must improve the UK's data protection framework for genomic testing, including implementing more effective data safeguards, given the risks and opportunities presented by technological developments and growing numbers of direct-to-consumer tests.

'This is timely, and an innovative attempt to regulate a market that has grown primarily for commercial purposes to date,' said Moin Saleem, Professor of Paediatric Renal Medicine at the University of Bristol. 'In the context of the public having growing access to individual genetic information, and therefore deeply personal data, it is absolutely necessary.'

'We welcome this report, and hope that it will stimulate wider public discussion of direct-to-consumer genetic and genomic tests,' said Sarah Norcross, director of the Progress Educational Trust (the charity that publishes BioNews). 'Government would be well advised to pay attention to this area if the UK is to maintain its position as a leader in genomics. Top-tier science and technology require top-tier regulation.'

First Report - Direct-to-consumer genomic testing
UK Parliament |  22 June 2021
MPs urge the Government to review regulations for direct-to-consumer genetic testing
UK Parliament |  22 June 2021
MPs urge the Government to review regulations for direct-to-consumer genetic testing
The Independent |  22 June 2021
16 August 2021 - by Rachel Horton and Professor Anneke Lucassen 
Direct-to-consumer genomic testing is a thriving market – for example by June 2020, 23andMe had sold over a quarter of a million testing kits in the UK...
5 July 2021 - by Georgina Al-Badri 
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11 May 2020 - by Isobel Steer 
'I just took a DNA test', sings Lizzo on her 2017 hit single 'Truth Hurts'...
9 March 2020 - by Christina Burke 
'What is it to be human? What is it to be family?' These are the words of this week's interviewee, Jack Nunn, on The Genetics Society 'Unzipped' podcast: 'Hidden family secrets unveiled by genetic testing'...
28 October 2019 - by Dr Laura Riggall 
By 2022 the world's consumer genetic testing market is expected to quadruple to £200 million, according to The Guardian. But while the popularity of DIY genetic testing has undergone huge expansion in recent years, doctors and scientists have called for a crackdown on tests offered by consumer genetics companies such as 23andMe and AncestryDNA...
21 October 2019 - by Jen Willows 
Direct-to-consumer genetic tests should not be used as a basis for medical decision making, according to two separate studies released last week...
9 September 2019 - by Eleanor Taylor 
The Progress Educational Trust (PET), which publishes BioNews, held a public event at Manchester's Science and Industry Museum to discuss genomics...
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