Personal-Genomics Companies Get California License

After sending cease-and-desist letters to a number of companies offering personal-genomics services directly to consumers, the state of California appears to have made peace with at least two of them–Navigenics and 23andMe. Both received licenses this week allowing them to continue to do business in California.

The letters, sent in June by the California Department of Public Health, outlined two main state regulations: laboratories performing tests must be clinically licensed, and a physician’s order is required for all clinical tests. (For more on the state’s action, see “Genetic Testing for Consumers Scrutinized.”)

According to an article published Tuesday in the New York Times,

The companies had argued that they were not offering medical testing but rather personal genetic information services, and that consumers had a right to information from their own DNA. The companies also said they did not need a license because the actual testing of the DNA samples was being done by outside laboratories that did have licenses.

But the two companies do their own interpretation of the raw genetic data. Now, after reviewing the procedures used by the companies, the state is satisfied that the companies’ interpretation is based on the scientific literature, Ms. Billingsley [a senior official in the California public health department] said.

Ms. Billingsley said the companies also satisfied the requirement for a doctor to be involved. Navigenics already was paying a physician to review customer orders and now it appears that 23andMe might be doing something similar.

It’s not yet clear what this latest development portends for future regulatory debates, especially at the federal level; few federal regulations for these types of tests exist. As their popularity grows, scientists, regulators, and entrepreneurs will need to grapple with the central question of how to define this new breed of medical information, which falls short of being a diagnostic tool and, unlike risk factors such as cholesterol level and blood pressure, is deeply personal and ultimately immutable.

For more on regulation of direct-to-consumer genetic testing, check out the review “Personal Genomics: Access Denied?” in the September issue of Technology Review.