23andMe is a personal genomics company based in Mountain View, Cal. Anne Wojcicki is co-founder of the company and Ashley Gould is 23andMe General Counsel.
Direct-to-consumer genetic testing has received a lot of government and media attention recently. Are you satisfied with how they have portrayed the industry and the technology?
We believe that ultimately the attention is useful in that we expect the industry to evolve and improve on the basis of constructive feedback. We think there is a good deal of misunderstanding of the technology we use and our scientific processes. We have been working and will continue to work to set the record straight in this regard.
The recent GAO report on DTC testing was highly critical of the industry and recorded some eyebrow-raising conversations between fictional customers and representatives from genetic testing companies, including 23andMe, and found a number of accuracy problems. How do you respond to the report's accusations?
The “eyebrow-raising” conversations were not in fact related to 23andMe, but other companies in the DTC space. We suggest that anyone looking for the facts read our blog following the GAO report and congressional hearing. As our blog explains, we do not agree with the accuracy accusations. Our processes have always been transparent, and the bases for our risk estimates are no exception to this transparency.
In the wake of the GAO report, what new FDA regulations are you preparing for? How would you like to see FDA handle regulation of the DTC testing industry?
We are currently working closely with the FDA and will provide updates as new developments arise.
Do you believe consumers can generally interpret their DNA test results without talking to a genetic counselor or doctor?
Our data indicates that consumers are quite capable of this, yet we are a data-driven company and there are ongoing independent studies assessing this question. When these studies are published the resulting data, and data that is continually collected, should provide additional insight into this question. Our goal is for customers to understand what there is to know about their DNA; in this regard, as you may know, in June of this year we launched the ability for our customers to contact independent genetic counselors informed about our service. We look forward to learning from published studies and incorporating any changes that will improve customers' understanding.
Why doesn't 23andMe include consultation with a genetic counselor as part of the 'Health Edition' DNA testing service?
We believe an individual has the right to decide if they would like to interact with a genetic counselor. As previously noted, in June we announced a partnership with Informed Medical Decisions, Inc., a national network of genetic counselors.
How much clinical utility can really be gleaned from results regarding health concerns with highly significant environmental components, such as heart disease?
The answer depends on the report—as we note that some reports have higher environmental components than others. Knowledge about genetics and its impact on health is constantly evolving. We work to make this point very well understood in different ways, from our agreement with our customers noting risks and considerations in obtaining our service (See Section 5 of our TOS which is presented to each customer and is on every page of our website), to our online genetics videos. Contributing to the knowledge and understanding of the meaning of genetics through our research was a large part of the reason 23andMe was founded. Despite the ongoing understanding of many aspects of our DNA, there are many well founded and well accepted associations with published correlations to health conditions. Our objective is to present our customers with what science can tell them about their DNA and provide digestible context for that information.
What safeguards does 23andMe have in place to prevent surreptitious testing?
The saliva collection device used by 23andMe requires a sizeable sample that can take anywhere from 5 to 20 minutes to collect. 23andMe also requires that each customer agree to specific representations, including that the saliva provided is their own. To date, we have never received a complaint or logged a concern about surreptitious testing.