Genes and Marketing

Genes and Marketing  section

Most genetic tests are currently only available through specialist genetic testing services in the NHS, where they are mainly used to diagnose genetic disorders or identify people whose children might inherit such disorders. However, a number of companies are already looking at ways of expanding the market for genetic tests by selling them on the internet, in high street stores, through private GPs or via alternative healthcare providers.

Genetic tests are not regulated there is no independent assessment of the claims made by commercial companies. This means that people could easily be misled about their health.

Genetic testing services require customers to provide a sample of their DNA (usually using a simple mouth swab) which is then sent to a laboratory. The laboratory will look for rare mutations or common variations in the person's genetic make-up. Customers may then receive any or all of the following:

  • predictions about their, or their children's, risk of future illness;
  • health advice about their lifestyle or which vitamin supplements or medicines to take;
  • products that are claimed to be tailored to their individual genetic make-up.

For more than a decade, GeneWatch UK has exposed companies making misleading claims about genetic test results. The EU's new IVD (In-Vitro Diagnostics) draft Regulation is supposed to regulate genetic tests but is effectively meaningless as it provides no regulatory check of the companies' claims. Read the GeneWatch UK briefing.

This GeneWatch briefing explains the commercial interests behind the plan, and the link with the plans to build a central database of electronic medical records in the NHS (the 'Spine') or the alternative proposed approach of allowing Google to manage these records. The ultimate aim is to market products to people based on their medical data and genetic make-up, massively expanding the healthcare market - for special foods (called 'functional foods'), medicines, skin creams and other tests and services - to the healthy population. More on genetic testing in the NHS is here.

The science behind this idea is deeply questionable. Some of the evidence for this is highlighted below.

The New York Times has published an article about why genes show limited value in predicting common diseases. New Scientist has reported a study which shows that the results of commercial gene tests are unreliable.

Scientists from the Netherlands and from the US National Office of Public Health Genomics have published an investigation of seven companies highlighted by GeneWatch as selling misleading gene tests. They concluded that "There is insufficient scientific evidence to conclude that genomic profiles are useful in measuring genetic risk for common diseases or in developing personalized diet and lifestyle recommendations for disease prevention".

UK scientists and medics have also warned about the lack of regulation of tests which try to predict the risk of disease in healthy people, including genetic susceptibility tests. A report by Sense about Science has warned that "There is a growing business selling new genetic tests based on very preliminary research - the evidence is far too flimsy to be accepted by evidence-based medical practice".

The Chair of the Primary Care Genetics Society has warned GPs of the potential dangers of genetic testing kits sold over the counter or via the internet.

A Sunday Times investigation, showing that commercial companies give conflicting genetic risk assessments based on the same DNA, also highlights how people cannot trust the genetic information they are being given.

New Scientist has reported a study showing how commercial gene tests give misleading predictions of genetic risk.

Subsequently, a study by Craig Venter and collegues, published in Nature, found major discrepencies in genetic risk predictions made by different companies (see the press report and Nature's Editorial).

A study in the British Medical Journal, published in January 2010, reported that that genetic testing provides no real help in predicting the risk of developing type 2 diabetes, a major risk factor for heart disease. The British Heart Foundation advised people not to buy genetic home screening tests for type 2 diabetes or heart disease.

The Times and New York Times have reported the difficulties being faced by companies attempting to market gene tests to sceptical consumers.

Customers are reportedly underwhelmed by direct-to-consumer genetic test results in the US and the inclusion of large numbers of potential diseases in the US newborn screening programme is leading to large numbers of false positive results.

A US FDA panel has warned that gene tests can be misleading and need more oversight. The American Medical Association has sent a letter to the US FDA highlighting the need for regulation of such tests. Reports about the limitations of such tests continue, including from some customers.

Reports from the Nuffield Council on Bioethics and 2020Health have questioned the reliability and usefulness of tests for genetic susceptibility to common diseases

In the journal Science, scientists have called for gene tests to be regulated following findings that results can be misleading. See articles on Forbes and Bloomberg.

In 2011, studies presented at the European Society of Human Genetics (ESHG) found that Direct-to-Consumer (DTC) genetic tests give inaccurate predictions of disease risks and that many European geneticists believe that some of them should be banned. Read the ESHG press release and the Guardian article.

This study found that genetic risk predictions from different companies give contradictory results.

Please note that information about specific companies may change after the publication date. For example, the US company Great Smokies Diagnostics Laboratory (GSDL) has changed its name to Genova Diagnostics. The UK company Health Interlink has asked us to point out that it severed its ties with GSDL over three years ago, shortly after its tests were launched.

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