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Direct-to-consumer genetic tests – more than just a question of health

14 December 2015
By Andelka M. Phillips
Faculty of Law, Oxford University
Appeared in BioNews 832

There is now a huge range of direct-to-consumer (DTC) genetic tests on the market. A distinction is often made between tests offered for health purposes and so-called 'recreational genomics'. Examples include ancestry testing or tests for traits such as whether you find Brussels sprouts bitter, but companies now also offer paternity tests and tests for matchmaking purposes, detecting infidelity, or whether a child is likely to have a particular talent. Consumers should be cautious about these. While some health tests may be useful, many tests for other purposes are not well validated, and it is sometimes questionable what in fact you are buying. Increasingly, companies that began offering tests for one purpose (perhaps recreational) are beginning to offer tests for other purposes. Consequently, what these companies are doing with consumers' sequenced genetic data and other personal data deserves more scrutiny. Can consumers really be said to have given their informed consent in this context? This is debatable, as is the enforceability of some of the contracts that customers are entering into.

As of 19 November 2015, 248 companies were identified offering some form of DNA test online within the last four years. I analysed 71 contracts used by DTC companies offering tests for health purposes (these often appear on websites as terms of use or terms of service). Significantly, I found that companies often include clauses allowing unilateral alteration of terms, and they may deem consent or acceptance of altered terms simply through the continued use of their website. Such clauses are particularly concerning because they allow for significant changes to companies' policies on use, storage, and sharing of data, without consumers being directly notified. In the UK, I hope that the new Competition & Markets Authority might be able to contribute to improving these contracts by preventing the use of certain terms, which might be deemed unfair.

Among these 248 companies, there are some you may have heard of – 23andMe, deCODEme, DNAFit, AncestryDNA, FamilyTreeDNA. Then there are others that you might not have come across, like Shecheated, Test Infidelity, GenePartner, Instant Chemistry or Who'z the Daddy? In my view, the FDA and regulators in other countries need to take action to protect consumers. Ideally, there should be industry-specific legislation that is consistently adhered to. The FDA recently sent warning letters to three companies, but there are more out there (see BioNews 828).

After the FDA's previous warning letter to 23andMe in November 2013 (see BioNews 733), it did cease offering health tests to its US customers, and its new US offerings are limited to carrier testing. However, it continues to offer health testing, including drug-response tests, through its UK and Canadian websites (see BioNews 783).

As many companies are located in the USA, the FDA's renewed regulatory interest is timely, but there are more companies out there. Also, while regulation of health-related tests is very important, we also need to regulate those companies offering non-health-related tests, which means that consumer regulators also need to take action (eg. UK's Competition & Markets Authority and the US FTC). However, regulators often have limited resources, so consumers need to be more aware of what's out there and how to protect themselves.

There is a real need for consumer education and increased awareness of the respective risks, benefits and limitations of these tests. Analysis of these contracts, together with examination of DTC website content, also shows that there is a need for companies to be more transparent. Often, marketing claims made on websites are at odds with the actual terms contained in DTC contracts. Companies offering services to EU consumers ought to comply with European Data Protection law and, at present, this is often not the case. Privacy policies also are not generally tailored to the nature of the services offered. Often they focus on the collection of personal data through cookies, rather than what companies are doing with consumers' actual genetic data once it is sequenced.

Companies providing tests for health purposes as well as some ancestry testing companies are generally at the better end of the spectrum of DTC services on offer and they engage in more responsible business practices. However, many other services ought to be viewed with scepticism, and consumers ought to be wary when considering them. These services include: testing for a child's 'talents'; testing for athletic ability; 'peace of mind' or non-legal paternity tests; DNA-based dating websites; and 'infidelity' tests. Companies that offer infidelity testing services often encourage consumers to send in DNA samples of dubious quality, belonging to third parties and without their consent.

When considering purchasing any DNA test online, I urge you to read the privacy policy and the contract. You need to know what is going to be done with your sequenced DNA. Stored, sequenced DNA identifies individuals and their families so, if you are concerned about long-term protection of your privacy, this is essential. Be aware that, since most DTC companies rely on self-sample collection, there is a risk of sample contamination through a consumer's inexperience. You should also bear in mind that most companies do not offer whole-genome or whole-exome scans, which means that the value of test results on a personal level may be limited.

Moreover, consumers need to be aware that, increasingly, companies are offering testing for more than one purpose. It is also very common for companies offering paternity tests to market infidelity tests. Increasingly too, ancestry testing companies are moving into health testing and health research. This means that you should consider whether you would be comfortable with buying an ancestry test, but then having your stored data used for other purposes.

In the long term, specific regulation of this industry is needed, and academics need to contribute to consumer education about the industry. In the short term, companies need to improve their contracts and increase transparency. If consumers were to actually read these contracts, they might notice the discrepancies with the claims on the website, and they might legitimately wonder what exactly they are buying.

Genomic Privacy and Direct-to-Consumer Genetics Big Consumer Genetic Data – What's in that Contract?
Paper presented at the 2nd International Workshop on Genome Privacy and Security |  21 May 2015
Think Before You Click: Ordering a Genetic Test Online
The SciTech Lawyer, Vol 11 No 2 |  1 December 2015
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