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Old 11-28-2014, 05:29 PM   #11
rhondalea
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Join Date: Jun 2011
Location: Somerset, NJ
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Re: No Travel Required - KRAS-Variant Mutation and Breast Cancer

Oh, and what a nuisance that was.

23andMe got whacked by the FDA for the health reports, so anyone who orders the test after November 2013 only receives the ancestry component. Everyone who had health reports before that, however, kept them. I still have mine. My daughter has hers. The raw data remained unchanged, of course, until 23andMe upgraded to the new chip. My father and my grandson are on the newer platform. Fewer SNPs, but apparently they're more relevant and useful.

So what everyone does now is to use the API to access third-party analysis tools, and some of us continue to do what we always did--research the individual SNPs and clusters of SNPs on our own using information in PubMed and at genome.gov and elsewhere.

23andMe's health reports were pulled from GWAS studies, and they were pretty basic. The FDA's issue wasn't/isn't with the data, because the chip is a standard medical testing device, and the testing itself is done in a CLIA-certified lab. But the health reports hadn't been subjected to the required scrutiny for what the FDA decided to call a medical device (the reports themselves), so Anne got spanked. (Edited to add: Her life was in great disarray before and during this mess--well-publicized husband trouble--so it's not a surprise that she lacked the focus necessary to keep the FDA placated.)

I'm still one of the admins on the FB page for the petition to the FDA asking it to stop being ridiculous. Not sure how I got sucked into that, but the petition eventually got delivered.

I have no idea whether 23andMe is still working on this or if they're satisfied with the way things are. The ancestry component is a big sell, and the company is still able to use the data for medical research even if it cannot provide neat little reports to its customers.

I think the other thing you're looking for is the lawsuit. Some ambulance-chaser in California got the bright idea to have his partner's wife order the test just before the health reports got axed, and then he filed a class-action suit. I haven't checked on the status of that in a while. I do know that most of the active 23andMe'ers sent him nasty emails, and a lot of people opted out in advance. I'm not sure what he hopes to gain. The test costs $99, and 23andMe has a pretty high customer satisfaction rate. Moreover, a good portion of those who take the test are more interested in ancestry than they are in health. I'll be interested to see how it all shakes out.

Edited to add: This is the latest on the class action lawsuit: http://blog.ericgoldman.org/archives...-v-23andme.htm
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