Rights to personal genome testing

15 March 2011

There have been strongly negative reactions to the news that an advisory panel to the FDA recommended obligatory clinical supervision of all results from genetic testing (see previous news).
The Genomes Unzipped response sets out a range of objections to the proposed moves towards heavy regulation in the US, as well as pointing to commentaries in the Genomics Law Report and Genetic Future blogs. It additionally underlines that the US stance is an example of extreme genetic exceptionalism – the view that genetic information in some way fundamentally differs from any other form of personal medical information; the authors instead point out that ‘DNA does not have magical powers’. They also note that distinguishing between medical and non-medical applications of DNA testing is likely to become increasingly difficult.
The PHG Foundation believes that regulatory oversight of such tests should be proportionate (see previous news) and endorses the points made by Genomes Unzipped - that restricting individuals’ access to their own genetic data is unethical, and that there is no evidence that clinicians are in general any better placed than consumers to understand the results from personalised genome testing, or that consumers are at significant risk of harm from these results.
A previously published article from the PHG Foundation [Wright CF, Hall A, Zimmern RL Genet Med. 2010 Oct 1] has suggested that regulatory oversight would be appropriate to ensure five key aspects of genetic test provision:
  1. Information – providing appropriate information and proportionate consent measures
  2. Analytical validity – quality assurance that laboratory assays meet the standards for testing
  3. Scientific validity – evidence that claims about genetic variants and links to diseases are genuine
  4. Access to advice – ensuring that consumers can access competent professional interpretation of results
  5. Claims – protecting consumers against misleading claims, including about the clinical meaning or usefulness of results

No reputable professional would like to see consumers misled, confused, distressed or indeed financially exploitedby any form of genetic testing. However, sensible and proportionate regulation combined with improved public education about the potential and limitations of testing is surely a better way forward than a hysterical witch-hunt that positions clinicians as the sole source of wisdom and protection. 

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