Is reading someone's genetic code the same thing as practicing medicine? That issue has always loomed over the nascent direct-to-consumer genetic-testing industry, which includes such well-known names as 23andme, Navigenics, and DeCodeMe.

It has become very real now that California public-health officials have ordered 13 online companies to immediately stop offering their services in that state.

The companies offer genetic tests that look for DNA mutations associated with a higher risk of developing heart trouble, dementia, or other maladies. Some critics have said that the science behind some of these tests is relatively new and may be incomplete.

Others say the tests are dangerous because they can identify risk factors for some conditions that have no treatment, such as Alzheimer's disease.

The California Department of Public Health contends the services violate medical-testing rules that require a physician's involvement and proof that tests produce a valid medical result.

The real issue, however, may be as much about turf and how society will react to this new technology as patient safety.

Companies offering the tests have made a point of sidestepping doctors, insisting that consumers have a right to know the information coded in their genes. They also have said that the results they deliver are informational, not diagnostic.

Bypassing traditional medical outlets is an important issue for these companies, since much of the medical establishment hasn't yet embraced widespread genetic testing. Traditional health-care providers tend to be skeptical of the usefulness of the results.

That skepticism would not bode well for a business model that depends on them to be the gatekeepers for ordering these tests. Requiring a doctor's approval also seems overly paternalistic to many believers of the Web 2.0 ethos of free access to personal information.

In the past, the state public-health department has laid out five criteria for direct-to-consumer genetic testing companies:

1. Is there a California licensed physician involved?


2. Are tests being authorized by a California licensed physician?


3. Does testing include pre- and post-test counseling?


4. Are tests being conducted at CLIA Certified [federally approved] labs?


5. Are the tests validated?