Apparently, the California Department of Public health has decided to call a halt to the marketing of genetic tests directly to consumers. Companies such as Navigenics, Family Tree DNA, 23andMe, and deCODEme, and others have received “cease-and-desist” letters from CDPH, asserting that the companies are operating in violation of California law. Navigenics and 23andMe are Silicon Valley-based firms.
Now what’s really curious about this is that it’s received very little coverage here in California. Aside from one brief article in the San Jose Mercury News, there’s been virtually no local reporting on the matter in California. And in fact, the CDPH doesn’t even have the issue listed on its website either under “News” or “Hot Topics.”
The basis for the cease-and-desist letters is to be found in California’s clinical laboratory technology statutes. The law prohibits the offering of a clinical laboratory test directly to a consumer without a physician’s order. The law also requires a state issued clinical laboratory license or registration for all persons receiving biological specimens originating in California for the purpose of performing a clinical laboratory test or examination.
One should note that not all these companies do the same things. Some are involved in “personal genomics” much more extensively than others which are constrained around the mainly genealogical aspects.
The other point is that there is not necessarily a violation of state law simply because a mid-level bureaucrat says there is. There are questions about how the statute was intended to be interpreted and even some constitutional questions here. On the other hand, the actions that California has taken in recent days may have a chilling effect on those companies doing business, or intending to do business in the Golden State, which is the nation’s largest domestic market.
Given the stakes involved here, GeneaBlogie will stay abreast of this story as it develops and we may have a special GeneaBlogie Legal and Policy analysis on the matter.
June 20, 2008 Friday at 8:27 pm