Crack down on gene tests

Thirteen genetic testing businesses in California have been ordered by health authorities to immediately cease and desist from offering genetic tests to residents until they have a clinical laboratory license from the state Department of Public Health.

As the Mercury News reports:

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 health department's statement also said that until a state laboratory license has been obtained, "any advertising for genetic services, whether it be in written word or by Internet, must clearly state that this testing is prohibited for California residents."...

According to Forbes, California is the second large state to begin cracking down on these internet companies, as New York has sent out similar warning letters:

The state won't identify which companies were mailed letters until it confirms those firms have received them. But high-profile gene testing companies that operate in California include 23andMe, founded by the wife of a top Google billionaire, and Navigenics, based in Redwood Shores...

One controversy is that... 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.

There are extensive scientific, medical, ethical and privacy issues surrounding private company gene testing. Many consumers don't realize how virgin this field is and how tenuous it is to make any conclusions about one's health risks from these personal gene screening tests. More worrisome, is how this genetic information could be misused before the science is better understood. Marcy Darnowsky, associate executive director of the Center for Genetics and Society based in Oakland, wrote today in the Cutting Edge that these companies promise to give you information about your risks for certain conditions, and even tell you what foods are optimal for your genetic profile. But, while, they may be heavily marketed by celebrities and hip venues, she cautioned:

Medical experts, bioethicists and science reporters - including some who typically greet DNA claims with unquestioning enthusiasm - have raised serious concerns about whether direct-to-consumer gene tests are ready for prime time.

First of all, they point out, we know little about the accuracy of these tests because they're so inadequately regulated. And if the tests are technically accurate, it's often unclear what they mean. For non-disease traits such as athleticism, the evidence for genetic links is sketchy at best. Even when a correlation between a genetic variation and a disease is strong, in most cases having it doesn't mean you'll necessarily get the disease; its absence seldom means you're home free...

If direct-to-consumer gene tests catch on, their harms may not be limited to individuals' health or privacy. One social issue on the horizon is the fate of the genetic trove that's being amassed. Google and other investors in the consumer genetics sector presumably see gold in them thar genes, but the people who pay thousands of dollars for the privilege of surrendering their DNA samples will have no claim. Who will control this genetic treasure, and who will profit from it?

Another issue is more subtle and perhaps more troubling. Will gene tests reinforce exaggerated ideas about the role of DNA in who we are as individuals and societies?