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.
"The state might not be aware of what we're doing," says Navigenics' Baker. (It might not know, for example, that a given company does no actual testing itself, instead sending its saliva or swab samples to a licensed clinical lab.) Alternatively, "there may be some new interpretation [of the laws] we're not aware of." Or the parties may have different ideas about who can order tests. The state might believe the client's personal doctor should do it, not a doctor hired by the company to authorize tests.
