Online Extra: Information Overload?
Anne Wojcicki, co-founder of the California-based genetic start-up 23andMe, talked with State Legislatures magazine about over-the-counter genetic testing.
S.L.: What are the advantages of DTC genetic tests that state policymakers should be aware of?.
Anne Wojcicki : One benefit of personal genome profiling that is often ignored is the role consumers can play in expanding the medical and scientific communities' understanding of genetics. 23andMe recognizes that not nearly enough is understood about genetics and it is our mission to advance this understanding. We soon will be embarking on our own research studies, using information voluntarily provided to us from our customers, which will seek to discover the connection between genetics, the environment, and certain traits and diseases. Because our company has a direct relationship with consumers, we believe we are equipped to do these studies more inexpensively and quickly than traditional methods have allowed. Our hope is that our research will contribute to better diagnosis and treatment of diseases. In the not too distant future, we expect that physicians will be able look at their patients' genetic profiles and assess the best health care plan for them, on an individual basis. We firmly believe personal genetic testing is a huge part of achieving this goal.
S.L.: On the other hand, critics cite disadvantages of these tests, such as a potential for consumers to misinterpret their results, sometimes inaccurate or misleading results, and a lack of stringent federal regulation of genetic testing laboratories. What is your response?
A.W.: We recognize that it is possible that people may misunderstand their genetic data if they are given incorrect or incomplete information. It is our responsibility to ensure that the information we provide is accurate and understandable and we take this responsibility seriously. We only provide information that is supported by published scientific studies. e distinguish between studies that have greater consensus in the scientific community and those that do not and we are constantly working to make these distinctions more immediately recognizable to our customers.
We have a team of geneticists in-house who review published studies and assess whether or not they meet our criteria for inclusion.We also explain the scientific consensus surrounding studies we include through the use of a star system. The star system provides a research confidence rating using anywhere from 4 gold stars (established research) to 3, 2 or 1 star (preliminary research) to distinguish the more thoroughly researched associations from those less well-researched.
Regarding regulation, we keep abreast of discussions regarding the regulation of personal genome profiling and expect to continue to be involved in such discussions. Ultimately we believe that our interests and the government's interests are aligned in that we both want to ensure that these services are accurate, reliable and that the health and safety of the general public are not compromised. We are interested in working with regulators to determine what additional rules, if any, need to be put in place to ensure consumers get high-quality information in the proper context.
S.L.: Many genetics policy experts call for increased regulation of DTC genetic test companies to protect consumers. In your opinion, is there a need for more stringent regulation? What impact would increased federal or state oversight have on the industry?
A.W.: Again, we support measures to protect consumers from inaccurate or incomplete genetic information. The impact of federal and state oversight obviously depends on the extent of the regulations.
S.L.: According to the Genetics & Public Policy Center, there are 13 states that prohibit DTC tests (specifically, they require a physician or other approved provider to order the tests) and other states allow DTC tests for certain conditions. What is the impact of these statutes (on consumers, for example, or the industry)?
A.W.: We believe that our service complies with currently existing law. The field of personal genome profiling is, of course, new, and there isn't yet a specific regulatory framework directed at services like ours. As we stated above, however, we are eager to work with lawmakers to ensure that consumers are protected.
S.L.: Where do you see this field of genetic testing in the next 5 or 10 years? What kinds of information will consumers be able to have about their health in the future?
A.W. We are hopeful that there will be significant advances in genetics in the near future. One change obviously will be cost. We expect the cost of genetic testing, including the cost of sequencing, to decrease. We also anticipate that researchers will have a much better understanding of the interplay of genetics, environment, and disease in the next several years. The combination of these changes could improve health care significantly, by allowing individuals and their physicians to make specific plans for the treatment, detection and treatment of disease.
Information Overload? - September 2008 Article