The House of Commons Science and Technology Committee has published its Direct-to-consumer genomic testing report, urging government to seize opportunities and address risks posed by the increasing availability and scope of consumer genomic testing.
Prof Moin Saleem, Professor of Paediatric Renal Medicine, University of Bristol, said:
“This is timely, and an innovative attempt to regulate a market that has grown primarily for commercial purposes to date. In the context of the public having growing access to individual genetic information, and therefore deeply personal data, it is absolutely necessary. The recommendations made are wide ranging and appropriate to cover many of the ethical issues that inevitably stem from unregulated genetic testing, as well as attempting to exploit the opportunity to enhance population based genetic research. If accepted and implemented, they would put the UK in a world-leading position in harnessing and making safer the growing impact of consumer-led genetic testing.”
Prof Felicity Boardman, Professor of Social Science in Medicine & Genomics, Warwick Medical School, University of Warwick, said:
“This report is significant in terms of the evidence based recommendations it makes, highlighting that in the future, direct-to-consumer genomic testing should be subject to external regulation, with better support for the public and consumers of these tests, including the need for genetic counselling. There is the possibility of overestimating the capabilities of genomic testing in the private sector (particularly in regards to predictive testing), whilst underestimating the potential for harms, not only for the person being tested, but also their wider biologically-related family, who are by definition implicated in the results. At a time when the role of genomics in the NHS is expanding, public trust around its capabilities to improve human health and flourishing is more important than ever. Ensuring that its uses, inside and outside the NHS, are appropriately regulated, with the provision of high quality support and information about possible outcomes, is an absolute priority to ensure that the decisions the public make about using this technology are as informed as they possibly can be.”
Sarah Norcross, director of the Progress Educational Trust, said:
“We welcome this report, and hope that it will stimulate wider public discussion of direct-to-consumer genetic and genomic tests.
“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.”
Prof Timothy Frayling, Professor of Human Genetics, University of Exeter, said:
“I welcome this report that calls for more accountability from the companies that sell genetic tests direct to consumers. There is a still a strong hint of snake-oil salesmanship around some of the providers, especially those marketing the tests as “personalised diet or fitness” tests.”
Prof Dusko Ilic, Professor of Stem Cell Science, King’s College London, said:
“Two concerns around direct-to-consumer genetic testing are:
“Firstly, that we need public education on genomic testing (at least a government-sponsored website).
“Secondly, we may need restrictions on who can have access to the data or request such test. It’s important to set boundaries now so that it isn’t possible in a few years for, for example, private health insurance companies to start using genomic testing to determine the premium and costs of coverage.”
Dr Stuart Hogarth, Lecturer in Sociology of Science and Technology, University of Cambridge, said:
“The UK Human Genetics Commission issued two reports on the regulation of DTC genetic testing (in 2003 and 2007) and then issued a document setting out key principles for a code of practice for the industry. This new report echoes many of the recommendation from the earlier HGC reports. This sector has been allowed to grow with almost no regulatory oversight, so this new report is to be welcomed. The new EU regulation on in vitro diagnostic devices will address most of the concerns about lack of independent evaluation of genetic tests when it comes into force next year. The question for the UK is what regulatory model will we establish post-Brexit. This report is a timely reminder of the need for tougher regulation of diagnostic devices and commercial testing services.”
‘Direct-to-consumer genomic testing’ was published by the House of Commons Science and Technology Committee at 00:01 UK time on Tuesday 22 June 2021.
Prof Felicity Boardman: “I don’t have any conflicts to declare; I sit on the foetal maternal and child health reference group (sub-committee of the national screening committee); my work is mentioned a number of times in this report.”
Sarah Norcross: “The Progress Educational Trust is a charity which improves choices for people affected by infertility and genetic conditions. No conflicts.”
Prof Timothy Frayling: “No conflicts.”
Dr Stuart Hogarth: “I am member of MHRA expert advisory group but speaking in a personal capacity. I worked with the Human Genetics Commission on the 2007 More Genes Direct report and on the subsequent principles document. I have been an invited speaker on regulation of consumer genetics at European Parliament and at the US Food and Drug Administration.”
None others received.