Wednesday, November 23, 2011

International Aspects of Personal Genomic Testing

Source: CDC's Genomics and Health Impact Blog
This article, written by authors from the Tel-Aviv University Faculty of Medicine and the University of California at Berkeley School of Law, is a discussion of personal genomics companies from an international viewpoint. Although most personal genomics companies are based in the United States, their clients can come from anywhere.

The clinical utility of the testing, from the early days, has been an issue. Early adopters of personal genomics, so-called ‘early spitters’, were driven by curiosity and perhaps even ‘informational exhibitionism.’

The authors have two main concerns around current oversight of genomic testing.
  • Whose DNA is being tested?
  • Who has access to the information?
How does a personal genomics company assure that only the tested person can send in and have access to the results?  Several possible scenarios are offered:
  • A politician sending in a DNA sample from a rival and ‘leaking’ information about his/her genetic proclivities
  • A defense attorney presenting genetic information on a crime victim
  • A prospective mother secretly testing the genes of several partners for a desired characteristic for her child
Access to personal genomic information depends upon who the ‘owner’ of that information is. If the owner is the company supplying the test, genetic information can be treated as any other commodity.

The authors make the following urgent recommendations:
  • Providers should self-regulate by forming a possible “Association of Personal Genome Service Providers” and should develop “Best Practices.”
  • Providers should clearly warn consumers that the DNA of another person cannot be submitted for testing without permission.
  • Customers should sign a statement saying that the DNA sample submitted is their own or that of someone in their legal custody.
  • “Providers should define themselves as ‘trustees’ of genetic information i.e. the information is held in trust for the benefit of another” and carries a fiduciary responsibility to that party.
Long term recommendations include:
  • Personal genomics units should be added to the European Medicine Agency (EMEA), the European Union and the Food and Drug Administration (FDA) of the United States.
  • Legislation clarifying ownership of personal genetic information should be instituted.
Gurwitz, David and Bregman-Eschet, Yael. Personal genomics services: Whose genomes? European Journal of Human Genetics, 2009 17(7): 883-889. doi: 10.1038/ejhg.2008.254 [Accessed November 21, 2011]