So, apparently I'm a complete and total sadomasochist who likes listen to health officials discourse on compliance issues with phlebotomy programs and CLS (what is that, even?) certification. I've been sitting here listening to the conference call of California health department conference call that Alexis Madrigal mentioned in his Wired post on the state's stance against direct-to-consumer genetic testing companies like 23andMe. I was after some sense of the thinking behind the position. My takeaway: California's health officials firmly believe that consumers just aren't capable of handling knowledge of their DNA unless it's mediated by a medical professional. Here's the flavor of the call from some notes I jotted down. The speaker is Dr. Karen Nickel, the head of California's laboratory field services program:
Genetic tests cannot be self ordered. [Direct-to-consumer genetic testing] puts us between a rock and a hard place...We're concerned about genetic businesses ordering tests from licensed labs without a physicians order...We've been dealing with this for six months now. We have investigated and this week sent cease-and-desist orders to thirteen of them for violating state law. This is very serious. We have consulted with legal and have full department support for this...We started this week no longer tolerating direct-to-consumer genetic testing in California.What I think makes this fascinating is that direct-to-consumer genetic testing is a clear case of what technology makes possible running smack up against the government's ideas of what should be possible. Sure, these are California officials, but think of it as the east coast mindset confronting the west coast one.
The public demand for access has created the 'worried well.' We need to clarify diagnostic vs. predictive reports. Many of these businesses will give 67% chance of colon cancer, 27% chance of this or that. Once they get the results they don't know what to do about it. So that's the state perspective. [Emphasis added.]
So is this a minor setback for genetic-testing companies like 23andMe or a major hurdle?

