Ethics of genetics testing in the era of diretc-to-consumer DNA tests
An article by Avi Lasarow, CEO of DNAFit
Our DNA is what makes us who we are. Tap into your genes and you might just be able to learn a lot about your body. Although DNA testing is still an emerging field, genetics helps us not only understand our bodies better but might also be a potential life-saver in the future; helping to cure and prevent a number of diseases through the trend of consumers wanting to proactively monitor and understand their health better. Gone are the days of doctors giving you your blood results, but welcomed are the days of systems like Wellness FX where you can plug in your data and get a visual representation of what to look for in health issue preventions! An exciting time which I link to the dot-com boom.
But genetic testing is also something that raises a lot of controversies. It uses the most personal information possible, and as a result, it has to be done with a very strict moral and ethical consideration. Especially now, during the rise of Direct-to-Consumer genetic testing marketplace.
Unfortunately, there’s still very little regulation in this field so there’s a big potential for companies to misuse the data they possess and provide results and information to their clients that are not based on any scientific evidence.
As a CEO of DNAFit, the 1st company to offer DNA testing for combined fitness and nutrition, it has always been a priority for me to make sure that the information we give is supported by enough scientific evidence to be viable. We have a strict inclusion protocol for the markers we use in our tests. An example? The genes we base our results on must all have had minimum 3 independent human studies performed which link them with the specific trait we’re testing for.
In terms of data generally, we make sure the information we gather about our clients is never misused. We collect hundreds of snippets on extremely personal data on a daily basis, and it’s imperative that our clients know what we do with it.
This is why we not only adhere to government regulation (such UK data protection act) but we have also decided to self-regulate and encourage every DTC genetic testing company to be extremely responsible and adhere to a strict set of rules:
· Provide detailed information about gene variants
All providers of DTC genetic testing should provide clear information to prospective customers about every gene variant included in the test.
· Provide a minimum evidence base for all reported gene variants
Variants should only be reported in a consumer test if there is a reasonable level of scientific consensus, based on human studies, showing their relevance to the test. The variants that are reported in a consumer test should be those that influence lifestyle changes from which health benefits may be derived.
· No misleading claims
DTC genetics companies should clearly state the limitations of fitness and nutrition genetics and make no exaggerated or misleading claims about the potential benefits of their product.
· Demonstrate strict laboratory & data protection standards
DTC genetics companies should disclose the location of the laboratory used to analyse samples to enable a customer to make an informed decision about the security of their DNA sample and the quality of the laboratory analysis.
· Ensure expert advice is available to explain results to customers
DTC genetics companies should have experts in their particular field available to explain results to customers.
· Be commercially transparent
If DTC genetics companies recommend or promote any additional products or services to their customers, such as nutritional supplements, they should clearly state if they have commercial relationships with third party suppliers.
· Customer consent should be mandatory before testing
Customers should be required to provide their formal consent to genetic testing and sign a declaration confirming their understanding of how their data will be used.
Personal genetics, in any field, is, of course, an emerging science. By the very nature of the industry, any company operating in this space will be naturally pushing the envelope, but the crucial mark must never be overstepped. It’s in the interest of not only the end user but also those with companies ourselves, that a strict standard of ethics and code of practice is adhered to. Without this, we will be limited in our ability to further the industry and bring ever-advancing science to the end consumer.
It’s an incredibly important time for our industry, with big players such as 23andme having just reached their agreement with the FDA, we’re on the precipice of a new era.
At DNAFit, we make it our strict promise to the customer and to ourselves that we will never overstep these boundaries set out, and I hope other companies in this space will do the same in an emerging industry where the consumer needs to know what they are buying and what can be expected from the test or service.