What Five FDA Letters Mean for the Future of DTC Genetic Testing
The FDA has published online letters sent to five personal genomics companies – 23andMe, Navigenics, deCODE Genetics, Knome and Illumina – informing the companies that they are manufacturing and selling medical devices without appropriate FDA premarket review and approval. No surprise that the news that the FDA has sent out letters to some of the most well-known providers of DTC genetic testing products is already making waves. (Daniel MacArthur was the first to point me to the AP story, and Mary Carmichael of Newsweek and Andrew Pollack of The New York Times were among the first to dive into the substance of the letters.)
Below, we will discuss the immediate and long-term implications of the FDA’s most recent regulatory actions for the five companies receiving letters, as well as for the DTC genetic testing industry. First, however, a review of the letters themselves is required. Each of the five two-page letters is signed by Alberto Gutierrez, Director of the FDA’s Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD), and follows a similar format throughout. To gauge the impact of these letters we will take them paragraph by paragraph.
The New York Times vs. Personal Genomics: Much Ado About Not Very Much
Earlier this month, there was speculation that The New York Times was preparing a piece “attacking” the “fledgling industry” of personal genomics (see: Linda Avey Versus the New York Times). The article in question, by reporter Andrew Pollack, was published over the weekend and, in retrospect, it’s hard to see what all the hubbub was about.
The title (Consumers Slow to Embrace the Age of Genomics) fairly reflects the tone of the rest of the article, which is a factual assessment of the business of personal genomics. In his piece, Pollack brings forth a standard set of issues confronting 23andMe and its peers (including Navigenics, deCODEme and Pathway Genomics). All are familiar, and most drive at a central challenge for these companies: demonstrating the value of their services and identifying customers willing to pay for them. (In a short, separate article that appears alongside, Pollack raises (but does not attempt to resolve) a much more controversial issue: whether personal genomics products represent medical tests or recreational services.) By and large, Pollack points out these challenges to the business of personal genomics without passing judgment.
