A British genetics company is calling for a Code of Conduct to ensure that direct-to-consumer DNA tests operate to ethical standards. The call comes as Google-backed genetics company 23andMe is being allowed to re-launch its consumer product after approval from the US Food and Drink Administration (FDA).
DNAFit has drafted a 10 point Personal Genetics Code of Practice – key standards it already adheres to. It now wants all other genetics companies to sign up to the code to ensure best practice across this emerging industry. The 10 points that all personal genetics companies should follow are:
· No direct-to-consumer (DTC) genetic testing for under-18s
Genetic tests should never be provided to consumers under the age of 18 unless through a health professional.
· No testing for talent identification or predicting sporting ability
DTC personal genetic testing should not be used as a predictive measure, nor as a means to identify which sport a customer should attempt or indeed even to influence the customer’s choice of fitness level or sporting goal. There exists no current ethical or scientific basis upon which to support the use of genetic information in this way, and this should be clearly communicated to the customer.
· 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.
· State clearly that genetics are only one element in a fitness or nutrition regime
Recommended fitness or nutrition regimes must not be built solely on genetic results. Environmental factors play a more important role than genetics.
· 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.
DNAFit’s mouth swab tests 45 gene variants scientifically-linked to a body’s capacity to respond to training and nutrition. It uses genetic variant scoring methods to determine an individual’s genetic power/endurance balance score to help devise bespoke diet and exercise programs.