The answers to these questions vary by company, and some of the questions are being debated as to exactly what they mean.

All three of the biggest providers—23andme, Navigenics, and DeCodeMe—conduct their tests in labs that have been federally certified, for instance, but only one, Navigenics, offers counseling. Navigenics says it also uses doctors to process orders.

The question of what is meant by a "validated" test is also open to debate. The tests are all "valid" in that they usually provide accurate information about one's genetic makeup—that is, whether one has a particular base (adenine, cytosine, guanine, or thymine) at a particular spot in their genetic code.

But most of the tests have not yet been through rigorous testing with human trials to confirm their accuracy and validity as predictors of risk factors for disease.

California's move comes several weeks after its health department said it was investigating consumer complaints against online-testing sites. Karen Nickel, chief of laboratory field services for the California Department of Health, recently told Forbes: "The tests have not been validated for clinical utility and accuracy, and they are scaring a lot of people to death."

New York State has also written to several online genetic-testing firms warning them they are not in compliance with similar laws in that state. The companies have suspended operations there as they hold discussions with authorities.

The federal Department of Health and Human Services plans to hold hearings in Washington next month to investigate online genetic testing. The hearings could lead to federal regulations.

As society sorts through the promise of this technology, doctors, hospitals, and other powerful economic and political stakeholders are likely to join the debate. Public-health bureaucracies also will continue to weigh in if they feel that these tests are a danger to the public.

Eventually, the stakeholders will come together, as they should, to forge a new mandate. What exactly this new DNA regime will look like will depend on all parties working together to insure what I believe should be three criteria for genome-wide genetic testing:

• Individuals have freedom of access to their personal genetic data.


• A system of trials and approvals be implemented that insure the validity of genetic tests and risk factors.


• Doctors and other experts have a vital role in the analysis of disease-oriented information and should use it as part of an overall diagnosis for a patient's health.

Balance is the key here, as in so many debates about markets. Overregulation can squelch innovation; under-regulation may lead to commercial abuse, consumer confusion, and distrust of these tests.