IS THERE a heart attack in your future? Or just the heartbreak of psoriasis or male pattern baldness? Companies offering genetic tests directly to consumers have proliferated. Send them your DNA, in a swab of your cheek or a bit of your spit, and they'll tell you what your genes tell them -- about your ancestry, characteristics, likelihood of developing a number of diseases and conditions.
Some test for mutations in particular genes that are linked to diseases, such as cystic fibrosis or breast cancer. Others take a big-picture approach, offering wide-scale scans of your genome.
On June 9, the state Department of Public Health sent letters to 13 testing companies operating in California telling them they were breaking California law and ordering them "to cease and desist performing genetic testing without licensure or physician order." Of the 13, five are in California, and the others are in other states or outside the country.
As of July 10, four have suspended business in California. But nine of the companies, believing they are in compliance with the law, are still up and running.
Now, as consumers are left wondering what the standoff means for them, policy experts wonder what it means for the industry long-term.
What exactly happened?
In its letter to the 13 direct-to-consumer genetic testing companies, the public health department told them they were violating two types of California laws: ones that require licensing of clinical laboratories located in California or that test biological specimens originating in California (such "specimens" include the cheek swabs or spit samples used in genetic tests); and ones that require any clinical laboratory tests offered directly to consumers to be ordered by a physician, unless the tests are specifically exempted by law. "Genetics tests are NOT exempt," the letters emphasized.
Why did the health department do this right now?
The action stemmed from "numerous" consumer complaints about the accuracy and cost of genetic testing services advertised online, says Lea Brooks, public information officer for the health department, adding that the department continues to receive complaints as well as inquiries from consumers.
Rick Weiss, a senior fellow at the Washington, D.C.-based Center for American Progress, a think tank that studies policy issues, sounded skeptical, saying: "One has to wonder whether these supposed complaints came from actual clients or from, say, some academic biochemist or a competing company not doing business in California."
Representatives of the three companies contacted for this story said they knew of no complaints about their own companies. And the letters from the health department did not discuss any prices consumers had complained about.
Who got letters, who didn't, and why?
Citing an "ongoing investigation," Brooks declined to explain how the department decided which companies would get letters and which wouldn't. The 13 receiving such letters included some big names -- 23andMe, deCODEme Genetics and Navigenics. Other heavy hitters, such as San Francisco-based DNA Direct, did not receive letters. (23andMe of Mountain View and Navigenics of Redwood Shores offer broad genome scans, while deCODEme, in Iceland, tests for specific diseases, as does DNA Direct.)
Ryan Phelan, chief executive and co-founder of DNA Direct, offers her own theory. "I believe the reason we did not receive a letter is because DNA Direct has always exceeded the guidelines provided by regulatory agencies," she says.
Some of the companies that did receive letters believe much the same thing about their businesses. "We are quite confused," says Mari Baker, president and chief executive of Navigenics.
How did the companies respond?
After the letters went out, four genetic testing companies who received them called it quits in California, placing disclaimers on their websites to prevent Californians from ordering. At least one company, SeqWright, decided to withdraw from the California market, even though it didn't receive a letter. But for others, including Navigenics and 23andMe, it's full steam ahead. Those two companies say they don't do lab testing themselves, but the labs they contract with are properly licensed. And physicians order all the tests, so they believe they're in compliance with state law.
Why does the state disagree?
Health department spokeswoman Brooks declined to discuss these issues because the investigation is ongoing. But company representatives, geneticists and policy experts suggested several possibilities.
