The state of California is starting to attack genetic testing companies like 23andMe. In Wired, Alexis Madrigal reports that

The state's laboratory field services group issued 13 cease-and-desist letters to genetic testing companies. Wired.com obtained a copy of the letters (pdf.) from two recipients. And the tough talk in a recent teleconference among regulatory officials confirms the seriousness of the department's intent.

"We [are] no longer tolerating direct-to-consumer genetic testing in California," Karen Nickles, Chief of Laboratory Field Services at the health department, told members of the Clinical Laboratories Advisory Committee on June 13.

Targeted companies include personal genomics startups 23andMe and Navigenics. These services are seen as the leading edge of a new type of health care in which consumers can use their genetic profile to tailor their medical and lifestyle choices. The established medical community, however, is wary of the technology arguing that the medical utility of some tests is unproven. Doctors also complain that direct-to-consumer services bypass them as the gatekeepers and analysts of medical information, which they worry could confuse consumers, not to mention cost them a billing event.

The health department's actions are a direct challenge to the viability of the infant DNA-testing industry, for which physician involvement is shaping up to be a major battleground. As far back as a September 2006 meeting, health department officials were voicing concerns over "nutrigenetic tests that analyze a limited number of genes to give personalized nutritional and lifestyle recommendations."

According to the Mercury News,

The agency said it began investigating gene-testing companies after receiving complaints from consumers "about the accuracy and cost of genetic testing advertised on the Internet." The agency declined to name the businesses, saying it would identify them after they confirm receipt of the letters. It said some were in California.

Forbes adds,

some gene testing Web sites take orders directly from patients without a doctor's involvement. (Navigenics says it uses a doctor.) California law requires that a licensed physician order any lab tests, including genetic tests, says Karen Nickel, chief of laboratory field services for the California Department of Public Health. All lab tests must also be validated for accuracy and medical utility, according to state requirements, Nickel says.

"These businesses are apparently operating without a clinical laboratory license in California. The genetic tests have not been validated for clinical utility and accuracy," says Nickel. "And they are scaring a lot of people to death."

Requiring that such tests demonstrate clinical "utility" could pose a particular problem if applied to 23andMe: The company has admitted its tests are not medically useful, as they represent preliminary findings, and so are merely for educational purposes.

California's move follows a crackdown on online gene testing firms by the state of New York, which sent warning letters to a number of firms, including 23andMe and Navigenics. California said its investigation followed a number of consumer complaints. "The consumers were unhappy about the accuracy [of the tests] and thought they cost too much," a spokeswoman for the department said.