DNA testing industry wrestles with California law
A CLOSER LOOK: GENE TESTS
The state has ordered 13 gene testing companies to 'cease and desist' while leaving other such firms alone. What does this mean to consumers? Read on for answers.
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."
