Genes and Marketing

Genes and Marketing section

You may also wish to vist GeneWatch's new website, My DNA, My Family, My Rights.

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 currently regulated in Britain or Europe: 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 20 years, GeneWatch UK has exposed companies making misleading claims about genetic test results.

A new EU regulation will protect patients and consumers by requiring companies to provide evidence that genetic tests and computer algorithms correctly diagnose or predict disease, before they can be marketed. This new IVD (In-Vitro Diagnostics) Regulation will require companies to provide clinical evidence to support the claims they make. However implementation of the regulations, which were due to come force in 2022, has been further delayed due to the pandemic.

Read the GeneWatch UK briefing about the EU's In Vitro Diagnostics (IVD) Regulation.

Following Brexit, the Medicines and Healthcare Regulatory Agency (MHRA) held a consultation on whether similar regulations should apply in Britain. You can read GeneWatch UK's response here.

The US Federal Drug Aministration (FDA) cracked down on misleading claims made for some genetic tests in late 2013. However, not all genetic test results are regulated by the FDA.

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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