I deleted the parent because I mistakenly thought they were using Affy SNP chips. I don't remember why I thought that, but you're correct in that they are using Illumina SNP arrays. This doesn't explicitly change what I was trying to say, but I hit the delete link a bit hastily.
My understanding is that the labs that run the tests are under CLIA, but diagnostic tests themselves are under FDA.
I think you are misunderstanding my point... my point is that there should be a big distinction between having access to your genomic data and having someone tell you what it means. Illumina's disclaimer is very clear (http://www.everygenome.com/about_us/our_lab.ilmn): They do not give you a diagnosis, medical advice, or a treatment recommendation. They give you a genome that you can take to your doctor and then discuss the results. In general, genotype data isn't something that you can easily interpret on your own (with few exceptions), and that interaction should be regulated.
My understanding is that the labs that run the tests are under CLIA, but diagnostic tests themselves are under FDA.
I think you are misunderstanding my point... my point is that there should be a big distinction between having access to your genomic data and having someone tell you what it means. Illumina's disclaimer is very clear (http://www.everygenome.com/about_us/our_lab.ilmn): They do not give you a diagnosis, medical advice, or a treatment recommendation. They give you a genome that you can take to your doctor and then discuss the results. In general, genotype data isn't something that you can easily interpret on your own (with few exceptions), and that interaction should be regulated.