On November 22, the FDA sent Silicon Valley’s leading personalized genetics company 23andMe a warning letter after six months of radio silence and recent increased efforts in marketing.
Excerpts from the chastising letter read: “As part of our interactions with you, including more than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications, we provided you with specific feedback on study protocols and clinical and analytical validation requirements … It is now eleven months later, and you have yet to provide FDA with any new information about these tests. You have not worked with us toward de novo classification, did not provide the additional information we requested necessary to complete review of your 510(k)s, and FDA has not received any communication from 23andMe since May.”
The FDA called for an immediate end to marketing of personalized genetics kits for health purposes, citing false positives and negatives related to BRCA genes and response to medications. After more than a week of debate and back and forth between the FDA and 23andMe behind closed doors and in the media spotlight, the company chose to freeze sales of its “spit kits” (personalized genetic tests) for health reasons today. Ancestry information and raw genetic data will still be available to consumers, and the company will continue its research efforts using the large pool of genetic data it now has collected.
I personally feel that 23andMe has a great product, but for the average consumer who may not have any background in health, wading through the results can be challenging. In college and medical school I took multiple classes on genetics, and I still don’t know how to interpret the risks for various diseases based solely on genetic codes.
Back in the summer of 2010 I took Stanford’s first personalized genomics class (which I just found a paper in PLOS ONE about … I don’t remember filling out these informed consents) where every student got genotyped through 23andMe, and we played around with the raw genetic data to look for new information not offered by the company (one that sticks out in my mind now is longevity based on your family history and DNA).
To be honest, most of the computational genomics were over my head, but the one thing I took away was that the field of personalized genomics is ever changing, and what may predict risk one day may be found to be something different another day. I know not to rely solely on my 23andMe results to make medical decisions. But are there people out there that do? I think so.
What I think would be helpful is to have more guidance from trained professionals to help people interpret their genetic data. Currently 23andMe teams up with Informed Medical Decisions, Inc. to provide genetic counseling if needed. But they are an additional expense, and people have to go out of their way to seek this service.
What if 23andMe could have genetic counselors on hand everyday online, available to chat via the web, on the phone, or in person? Or maybe consider having patients choose whether or not they want to discuss the results with their primary care doctor at their next visit, and sending over the results before the appointment.
From a research standpoint, 23andMe is fantastic and I hope they continue to study their huge samples of genetic code. And eventually I hope that people can have access to spit kits again. They just may need a bit more help to understand what their genetic language truly means.