23andMe.com is having troubles with the US FDA, or Food and Drug Administration. You can read more about the issue from a genealogy perspective here. Roberta J. Estes runs an excellent blog about DNA and genealogy and what's going on where, so thanks to her for being first in my inbox with this blog post!
If you feel strongly about this issue, there's a petition to be signed here requesting that the White House take it under advisement and step in. I couldn't wait to click through and sign that sucker!! I have personally benefited from the medical results on the 23andMe test. It pointed out an obscure genetic anomaly that I have taken up with my doctors and that we're pursuing together. So, thank you 23andMe.com.
As Roberta writes, anyone who tested with 23andMe.com should go download both the raw data as well as the medical results overview, and she gives a nice tutorial on exactly how to do that. Those are the two things all 23andMe testers should do now. Right now. That secures you in case of a worse case scenario and the FDA bring 23andMe to it's knees and having to close its doors. And that would be a tragedy of monumental proportions in this blogger's eyes.
As for my own thoughts on the matter, the FDA needs to focus on more serious matter and get up to date on consumer DNA test kits. These tests do not by any means diagnose disorders but simple give clues about stuff you might want to look at and maybe bring to your physicians attention. We, as consumers, should not have to get a prescription from out docs for a home DNA test, a pregnancy test, or glucose sticks. Why, oh why, can you test at home for an STD but not DNA?
As I read the FDA's statement, or rather letter to 23andMe, it seems that they are concerned that we consumers might be afraid of the results. What humanly civil might be said about that, I don't even know. My thought is that anyone who uses a home DNA kit for genealogical or medical information might have the intelligence to comfort themselves should the results not be rosy. And to know what to do next. And errors? The FDA is worried about errors? Have you ever had a false positive on a medical lab test? I sure have, and where's the FDA now?
Ugh!
Meanwhile back at the ranch, I've made doubly sure that both Mom and I have downloaded our raw data as well as the health report overview and any other health information that might be useful, should the worse case scenario come to pass. We've pretty much contacted all the DNA relatives we care to, so we're good there and are simply waiting for new ones to arrive.
Guess that we're lucky that my brother and his wife chose to test when they did because their kits are now at the lab being processed. Talk about good timing!
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