- I am 2.8% Neanderthal. Don't feel too superior though. I'll bet you have somewhere near that. I know someone else who is 3% Neanderthal. So there.
- Steve (husband) and I are not related/share no DNA (well, beyond in the way we all are/do) which is a relief since we have children. Why that's a relief, I don't know. Modern American taboo, I suppose.
- I'm 98.6% European (um, duh), 0.4% Sub-Saharan African and 0.2% East Asian and Native American. Go here to see a cool break down of all that and get an idea of what 23andMe can tell you about yourself.
The FDA, 23andMe and, Um, Me
What I took away from recent regulatory and legal action is that the FDA doesn't want 23andMe marketing the health aspects of their DNA sequencing kits without approval of the kit as a medical device. And the lawsuit is related to fear that people will get health information and do unwise drastic things, like get a mastectomy upon learning that have certain nasty BRCA genetic variants (those that indicate potential for breast cancer). It's all more detailed and complex than that, of course.
Some of the concern, it seems, is about the actions people may take based on their results. As a happy customer, the whole thing irritates me. There is no do-it-yourself breast removal shop. Fortunately for me, I didn't have the BRCA SNPs show up in my data. But if I had, I would have talked with my doctor and gone from there. I'd likely have had multiple consults before sliding onto a surgery table and facing a scalpel.
In fact, in addition to the simply cool stuff I can look at in my results, I learned that I carry a certain gene variant that has serious health implications. The timing was incredible. This is tough to get into without giving away too much personal information, but by knowing this information I was able to avoid action that may have had deadly consequences. I am grateful to 23andMe for allowing this discovery.
What Now, 23andMe?
In 23andMe's own words (on 23andMe.com Health page as of 12/6/13):
Changes to our health-related product.
At this time, we have suspended our health-related genetic tests to comply with the U.S. Food and Drug Administration’s directive to discontinue new consumer access during our regulatory review process. In the future, you may be able to receive health-related results, dependent upon FDA marketing authorization.
How does this impact you?
We want to make clear that we stand behind the data we generate for customers and are proud of profoundly improving the lives of so many customers. Our lab partner adheres to strict quality standards that are part of the Clinical Laboratory Improvement Amendments of 1988 — known as CLIA. These are the same standards used in the majority of other health and disease-related tests. We decided several years ago to comply with CLIA guidelines to be consistent with other types of laboratory testing and to assure customers about the quality of data. Our testing has shown a greater than 99.9 percent accuracy rate.
We remain firmly committed to fulfilling our long-term mission to help people everywhere have access to their own genetic data and have the ability to use that information to improve their lives.
This post is part of ThinkKit by SmallBox. Today's prompt to interview people about their year didn't fit with my need to be a temporary hermit. Instead, I took a lifeline. Sort of.