Personal-Genomics Companies Get California License
Navigenics and 23andMe can now sell to state residents.
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,
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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.
