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Affymetrix is not their vendor, Illumina is. With all due respect you don't seem to know much about this space. The vast majority of laboratory developed tests

by temphn 15y ago

Affymetrix is not their vendor, Illumina is. With all due respect you don't seem to know much about this space. The vast majority of laboratory developed tests (including millions upon millions of blood and urine tests done every year by LabCorp and Quest) are not cleared by the FDA. They are regulated by CLIA, like 23andMe is. So we are not debating "zero" vs "some" regulation. This is a turf war between two agencies in HHS: FDA vs. CMS. It has nothing to do with safety and everything to do with jurisdiction and funding dollars. FDA is also going after other "sister" agencies within HHS, like Blumenthal's ONC, to take over regulation of EMR and get the bling. If Shuren can get both LDTs and EMRs classified as "medical devices", he will at a stroke have increased CDRH's ambit from just "medical devices" to all laboratory tests and all medical records in the US. It will no longer be a distant third in funding to CDER and CBER, the drugs and biologics/vaccines groups in the FDA. And budgets will be increased to match. What we are debating is whether 23andMe should face $50 million of regulatory costs (to get a 510k through the FDA) vs. $5 million of regulatory costs (the ballpark amount to get a CLIA lab running). http://www.bloomberg.com/news/2010-08-04/medical-device-makers-face-revamped-u-s-rules-for-approvals.html http://www.bloomberg.com/news/2010-08-04/medical-device-make... "The cost of clearing a device through the existing 510(k) program may range from less than $1 million to as much as $50 million, compared with $50 million to $150 million under a more- stringent FDA program for higher-risk devices such as heart pacemakers"

mbreese 15y ago
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 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.

by temphn 15y ago

mbreese 15y ago

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 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.