By Helen Wallace

from GeneWatch 28-3 | Oct-Dec 2015

In the United States, action by the Food and Drug Administration (FDA) against companies selling health-related genetic tests online, such as the Google-funded company 23andMe, has made headline news. But few people realize that 23andMe began marketing their tests in Europe after the FDA imposed its ban, taking advantage of a lack of regulation.[1][2] In the UK, the high street store Superdrug is selling unregulated genetic tests which have been banned in the U.S., and the tests are also available online.[3] 23andMe has been encouraging families to test their children, contrary to ethical advice.[4]

23andMe's actions have been widely criticized by doctors, particularly because new European gene test regulations are close to being finalized, following recognition that assessment of health claims is essential to protect consumers. Likely to be adopted in 2016, this regulation is expected to have a five year lead-in time, but will ultimately require companies to provide evidence of the scientific validity of the tests they sell.

Direct to Consumer (DTC) sales of health-related genetic tests have been contentious in the UK since the UK company Sciona began selling gene tests with dietary advice in high street stores in 2001.[5] GeneWatch UK conducted investigations into the scientific validity of Sciona's tests and those of other companies and found most health claims could not be substantiated. Our findings were subsequently reinforced by investigations by the US Government Accountability Office (GAO)[6],[7] and academic researchers.[8] In 2008, a Sunday Times journalist exposed how different companies selling gene tests in the UK would give consumers contradictory interpretations of their genetic code,[9] a problem that was exposed again in the USA in 2013 by the New York Times.[10] Regulators were slow to act, though, given that commentators first highlighted a need for regulation in the 1990s.[11][12]

After more than a decade of the debate, Europe's new In Vitro Diagnostics (IVD) Regulation will finally regulate software and algorithms used for health diagnoses or predictions, including genetic and genomic tests, in the European Union.

The IVD Regulation has now entered so-called "trilogue" negotiations between the European Parliament, the Council (which represents the Governments of EU member states) and the Commission (the EU's civil service, which wrote the first draft of the new law).[13] The final outcome will be a compromise between the three versions of the text, which will then be accepted or rejected by the European Parliament, probably next year. This means some issues have been settled, while others will be decided during the negotiations.

In the EU, powers for prior pre-market assessment of genetic tests are weaker than those exercised by the FDA, and it is expected that most oversight will remain with "notified bodies" which act as consultants to the companies making applications to sell tests on the EU market. This has led to some doubts about the quality of scrutiny of the evidence that companies provide. Nevertheless, for the first time companies will be required to collect and submit evidence about the scientific validity of genetic tests they place on the EU market, including their predictive value.

Clauses which ban direct-to-consumer (DTC) sales of health-related genetic tests and make counselling mandatory appear only in the European Parliament's version of the draft regulation, and remain contentious. EU member states disagree on the substance of a DTC ban, and the Council also argues that counselling provisions are an issue for each member state, not a decision that should be made at the European level. However, these clauses reflect widespread concerns about DTC genetic tests and their impacts on both individual patients and European health services. Universal health coverage in European countries, funded directly by taxpayers or by social insurance, means there is concern not only about the impacts of misleading tests directly on consumers but also about the potential for scarce healthcare resources to be misdirected towards follow-up of poorly predictive tests or algorithms bought without advice from doctors.

Another proposal in the European Parliament's version of the Regulation is that tests marketed with a recommendation to take a particular drug depending on the outcome of the test (known as "companion diagnostics") should require companies to supply evidence that the combination of the test and the drug improves health outcomes (i.e. shows "clinical utility"). However, this proposal is not included in either the Council or the Commission versions of the text.

Strict regulation would restrict the market for genetic tests and other health-related algorithms to those that genuinely showed some benefit to health and would prevent companies from making unsupported and misleading claims. It is too early to say exactly what requirements will appear in the final version of the EU's new IVD Regulation. However, it is clear that the days when companies could market genetic tests to European consumers with entirely unsubstantiated health claims are drawing to an end.

Helen Wallace, PhD, is Director of GeneWatch UK.



[1] The FDA won't let 23andMe test your genes - so it may go to Europe. VOX. 12th May 2014.

[2] Controversial DNA test halted in the US comes to UK. BBC. 2nd December 2014.

[3] Superdrug criticised by doctors for stocking genetic self-testing kits. The Guardian. 31st March 2015.

[4] Mrs Google's DNA test for her unborn girl: Wife of internet tycoon has daughter tested for risk of cancer, Alzheimer's and Parkinson's in later life. Mail on Sunday. 24th January 2015.


[6] US Government Accountability Office (2006) Nutrigenetic testing: tests from four websites mislead consumers. July 2006.

[7] US Government Accountability Office (2010) Direct-To-Consumer Genetic Tests: Misleading Test Results Are Further Complicated by Deceptive Marketing and Other Questionable Practices July 2010.

[8] Janssens ACJW, Gwinn M, Bradley LA, Oostra BA, van Duijn CM, Khoury MJ (2008) A Critical Appraisal of the Scientific Basis of Commercial Genomic Profiles Used to Assess Health Risks and Personalize Health Interventions. The American Journal of Human Genetics 82, 593-599. .

[9] Rival genetic tests leave buyers confused. The Sunday Times. 7th September 2008.

[10]I Had My DNA Picture Taken, With Varying Results. New York Times. 30th December 2013.

[11] Hogarth S, Javitt G, Melzer D (2008): The current landscape for direct-to-consumer genetic testing: legal, ethical, and policy issues. Annu Rev Genomics Hum Genet 9:161-182.

[12] Hogarth, S (2010) Myths, Misconceptions and Myopia: Searching for Clarity in the Debate about the Regulation of Consumer Genetics. Public Health Genomics 13:322-326

[13] European Council (2015) Medical devices: Council mandates presidency to start talks with EP. 23rd September 2015.

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