“Huge potential gains”: Personalized nutrition experts welcome regulatory proposals for UK genomic testing

25 Jun 2021 --- A report from the UK House of Commons Science and Technology Committee is calling for tighter restrictions around direct-to-consumer (DTC) genomic tests.

While the report largely focuses on tests for medically related purposes, consumers are increasingly turning to similar services for personalized nutritional advice. Experts in this space tell NutritionInsight why these proposals have been broadly welcomed.

“There are currently no specific UK regulations that can suitably cover the current genotyping services offered to individuals commercially. The report from the House of Commons will act as the basis for such regulations to be formulated,” explains Dr. Yiannis Mavrommatis, senior lecturer in nutrition at St. Mary’s University. 

The inquiry stems from a proposal from the Nuffield Council on Bioethics.

He contributed to the House of Commons inquiry and is also the head of nutrition and genetics for Nell Health, a DTC genotyping company.

“Lack of regulations in commercial genotyping is a global issue, and the current report shows once again that the UK is among the world leaders when it comes to personalized healthcare,” Mavrommatis continues.

“It also means that any proposed regulations should cover genotyping services that are offered in the UK from other countries, which is a considerable challenge.” 

Too powerful?
Jeremy Poland, CEO of personalized supplement platform Nutri-Genetix, agrees with the committee’s proposal that the tests be subject to greater pre-market assessment by an external body.

“This is a good thing, on the provision the focus is on test reliability and does not result in unnecessary limits on consumer choice and an impediment to test innovation. There are huge potential gains for consumers as understanding of the human genome improves, and we are able to make lifestyle changes that deliver real tangible benefits,” he states. 

Mavrommatis argues that genotyping can be too powerful to be offered without pre-market assessments. 

“Pre-assessment will facilitate better advice and clearer results, so everybody should welcome such regulations. It will also limit the space for over-promising and inappropriate recommendations, which can be harmful to both DTC companies and the consumer,” he details.  

Bringing in external assessment
The report points out that most providers are currently able to self-declare their products’ conformity with the existing regulations. The Medicines and Healthcare products Regulatory Agency suggests this restricted its ability to ensure that genomic tests on the UK market provided reliable results.

Therefore, the committee suggests that any such external assessment should cover the test’s clinical performance, as well as its analytical performance.

Furthermore, the report recommends that the government considers amending the current regulation of direct-to-consumer genomic tests to revise the requirements on information and support provided to consumers.

Data sharing considerations
It also proposes that the government works with Genomics England and the NHS to define clear technical standards for testing. If met, this could enable genomic data generated by the test to be used and trusted by Genomics England and the NHS.

The UK government aims to “establish a gold standard UK model for how to apply strong and consistent ethical and regulatory standards.”Another key aspect of the report is its focus on developing a data protection framework. “We know that privacy concerns are the main reason that may stop an individual from seeking genetic-based advice, so we cannot say that the public is not aware,” says Mavrommatis.

However, Poland observes that “quite surprisingly,” most people are not overly concerned with data privacy. Nutri-Genetix only tests for genes relating to nutrition requirements, and the samples are destroyed quickly after the test.

Role of industry
Currently, the majority of DNA testing focuses on paternity and other areas of health. However, companies like DnaNudge, Mako Medical Laboratories and Nutrigenomix are offering personalized nutritional advice – tapping into a significant demand for tailored solutions. 

“Genotyping can add an extra layer of knowledge in the development of recommendations. If you add genetic testing appropriately to the individual characteristics of the consumer, then it is more likely that your recommendations are appropriate and the consumer will adhere to them,” explains Mavrommatis.

However, he points out that if genotyping is used as the sole basis for recommendations, consumers could be misled, causing “more damage than benefit.” 

“Nonetheless, evidence shows that general nutrition recommendations are not efficient anymore. The Department of Health and Social Care in the UK has made personalization through genetics its priority in its healthcare strategy for this decade. This encouraging environment helps the public to appreciate the potential benefits of receiving evidence-based personalized advice,” Mavrommatis concludes.

It’s been a busy week for UK nutritional regulation, with the country also eyeing a post-Brexit nutraceutical regulatory overhaul, as well as bringing in tighter advertising restrictions for junk food. 

By Katherine Durrell