The recommendation is one put forward in a report by the UK’s Science and Technology Committee, in which they say genomic tests or ‘wellness’ tests must be scrutinised for performance.
“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),” the report states.
“This assessment should also cover the test’s analytical performance (how well a test predicts the presence or absence of a particular gene or genetic change)—which is the focus of requirements on direct-to consumer genomic tests currently.”
The report was compiled in response to the growing number of genomic-based services such as 23andMe and DNAfit that offer techniques for measuring all or part of an individual’s DNA sequence.
The theory underpinning these services focuses on identifying specific genes that determine how that individual responds to certain nutrients or foods, forming a basis to create a genetically tailored diet or exercise plan.
‘No regulatory oversight’
“This sector has been allowed to grow with almost no regulatory oversight, so this new report is to be welcomed,” says Dr Stuart Hogarth, Lecturer in Sociology of Science and Technology, University of Cambridge.
“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.”
The report also recommends clear technical standards be defined for direct-to-consumer genomic testing that would enable Genomics England and the National Health Service (NHS) to use trusted genomic data.
The development of such standards, which manufacturers of direct-to-consumer genomic tests could voluntarily meet, could reduce the likelihood of false positive or false negative results.
This would also facilitate data sharing, which could potentially support research efforts; and reduce the need for the NHS to re-test individuals following a commercially obtained test.
But Felicity Boardman, Professor of Social Science in Medicine & Genomics at the University of Warwick, pointed out the possibility of overestimating the capabilities of genomic testing in the private sector (particularly in regard to predictive testing).
The possibility extends to 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.
Transparency and support
“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,” she comments.
“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.”
Other recommendations focused on amending current regulations of direct-to-consumer genomic tests to increase transparency and support to users.
“This could include requiring companies to inform consumers of the potential consequences of genomic test results for their relatives or requiring external assessment of the information provided,” the report concludes.
“Medical supervision or the provision of genetic counselling could also be required for at least some types of genomic testing offered directly to consumers.”
Moin Saleem, Professor of Paediatric Renal Medicine at University of Bristol called the report, ‘a timely and 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.”
