It’s funny how different comments sections look when you understand the underlying area. I have to assume that all comments threads have thing like these:
The FDA has clearly lost its way. Is a drugstore pregnancy, cholesterol, HIV or other test a ‘medical device’? No.
Actually, it’s more “yes”. They’re all medical devices, but some are “waived”. There’s a list published in 1992 of “waived” tests, and it’s very short. Even if you have a test simple enough to meet the definition, if you want to add something to the list, you have to apply. There’s an HIV test on there now (Orasure), but it’s still a medical device, just a waived one. Here’s Orasure HIV ab card in the FDA index.
As long as 23andme is licensed and accredited by an organization such as the College of American Pathologists, they should be able to offer their product/service.
Well, here you’ve hit on a serious issue that may be what lets FDA get away with this. 23andMe’s laboratory is licensed and accredited - I have been told it’s LabCorp, one of the biggest outfits out there with multiple labs in multiple locations. But 23andMe is not a laboratory, it’s a separate company that sends tests to the laboratory. The FDA is not currently requiring a laboratory to submit for FDA approval (labs come under CMS, often with CAP accreditation) but FDA define a laboratory developed test (LDT) as something developed by the doctors in a single laboratory. Since LabCorp (I believe) do the raw data and 23andMe do the analysis, it doesn’t count as an LDT, and FDA gets an in. This is a gigantic black hole of a grey area, if I may coin a phrase, and FDA is taking full advantage of it.
The reason I had to go through all that: New York State does not allow its citizens to participate in genetic testing by private labs. Only physicians can do so. Why?
Because NYS DOH is the only state that really spends time an money on health care provision and a laboratory finds obtaining NYS DOH approval is almost as hard as a device manufacturer obtaining FDA approval. (Because NYS apply it to laboratories, the FDA’s distinction above does not apply.)
If there are quality issues, the Consumer Protection Agency should intervene.
You can’t have the government you have in your head, you have to have the one that exists in real life. In real life, reports of adverse events from medical devices go to FDA, not CPA. I’m sure we can all vote to change that but right now…
Edit to add: IANAL, and this isn’t legal advice.
