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Akron Univ. School of Law

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Tuesday, July 15, 2008

DNA Testing Industry Wrestles with California Law

The Los Angeles Times reports that as a result of violating two types of California laws, the California State Department of Public Health ordered thirteen DNA testing companies operating in California to stop performing genetic testing.  Consumer complaints about the accuracy and cost of genetic testing services advertised online fueled action by the state.  Four of the thirteen companies have already been suspended.  Karen Ravn writes,

Dna2Is 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.

"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.

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?

The health department has legal options -- seeking injunctions, pursuing criminal prosecutions -- to stop companies from continuing to practice their businesses. It will not comment on its plans. Representatives of Navigenics and 23andMe say they would like to meet with state health officials to discuss the impasse and try to resolve it. "There could be friendly compromise, or it could end up in the courts," Weiss says.

Do we need new rules and regulations for this new industry?

Greely thinks so. "The current legislation was certainly not written with this industry in mind," he says. Hudson says the main goal of state or federal regulations should be to guarantee that tests are safe and accurate and that claims made about them are truthful. Ideally, federal laws would be written, says Dr. Robert Nussbaum, chief of the Division of Medical Genetics at UC San Francisco: "State by state would be a nightmare." There are no federal laws yet on the matter of direct-to-consumer gene testing.

Still, Weiss cautions that medical regulation has historically been up to the states, and he doubts they'll want to give up control entirely.

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