If that's the case, then Kathy Hudson, director of the Pew Genetic Testing Quality Initiative at the Genetics and Public Policy Center at Johns Hopkins University, agrees with the state. She believes clients should have a relationship with the doctor who orders the test -- the kind they have with their own doctor.
Hank Greely, director of the Center for Law and the Biosciences at Stanford University, believes the level of physician involvement at companies like Navigenics and 23andMe may be sufficient to comply with state law. And the fact is, of course, that tests for pregnancy, glucose and blood cholesterol are already exempt from the requirement to have a physician.
There is some disagreement on when gene tests should be considered "clinical laboratory tests." A gene test to establish your descendants can turn up fascinating -- or disturbing -- details such as having Genghis Khan for an ancestor. But the state doesn't consider genealogy (or paternity) tests to be medical tests, so they're not subject to the laws requiring licensed labs and doctors' orders.
Navigenics and 23andMe don't believe the gene scans they provide are medical tests either. "We see our service as informational, rather than diagnostic," says Linda Avey, co-founder of 23andMe. "Our service tells customers how their risk for certain conditions is affected by their genotype but cannot tell them that they have or will get those conditions."
Genetic tests that provide information about disease risk are indeed medical tests, counters Hudson. "To say otherwise is untruthful and threatens to undermine the promise and hope we have for the real public health benefits of genetics," she says. Adds Greely, "You can't sell people on the health benefits of your service and then say it isn't about medicine."
Does this mean Californians can't order genetic tests anymore?
No. Some companies didn't receive the letters at all, and some that did are still offering tests.
Can I order a test from a company in another state or country?
No matter where a company is located, if it offers tests to Californians it's supposed to comply with California law. Some companies outside the state are still offering tests to Californians.
Where do things go from here?
