Genetic test makers are defending their fledgling industry and arguing the benefits of marketing their disease-predicting kits directly to consumers before regulators from the Food and Drug Administration.
The two-day meeting will shape the regulation of technology that has attracted millions of dollars in venture capital investments, as well as skepticism from doctors and scientists.
Companies like 23andMe Inc., deCODE Genetics and Illumina Inc. sell saliva-based test kits that attempt to predict the likelihood of developing heritable diseases like breast cancer and Alzheimer's Disease.
The companies have marketed their services to consumers online for years, but in the last year the FDA has begun scrutinizing the technology for the first time.
In June, the FDA issued letters to a half-dozen genomic testing firms, asking them to submit their products for federal review.
At the meeting Tuesday in Gaithersburg, Md., the FDA will ask a panel of experts about the risks of marketing genetic tests to patients without the involvement of doctors. The 22-member panel will also weigh in on the scientific standards for direct-to-consumer genetic tests and whether they should be held to the same standard as prescription-only tests.
The biology of how DNA variations actually lead to certain diseases is still poorly understood, and many geneticists say tests offered by companies like 23andMe are built on flimsy evidence. Since the tests could be used to make medical decisions, the FDA has suggested they should be regulated at least as strictly as pregnancy tests and other at-home tests.
Mountain View, Calif.-based 23andMe will argue that regulations must be flexible to accommodate the rapidly evolving field of genetics. According to a copy of the company's presentation, representatives will also say they can help avoid the misinterpretation of genetic data through in-depth video explanations and connecting patients with genetic counselors, as needed.
23andMe was co-founded by Anne Wojcicki, wife of Google co-founder Sergey Brin. Google and Brin have separately invested several million dollars in the venture.
The FDA's panel will hear from companies and academic researchers on Tuesday and make recommendations on Wednesday. The FDA will consider the panel's advice as it drafts regulations on consumer-directed genetic tests.