DNA testing industry wrestles with California law

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DNA testing industry wrestles with California law

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.

By Ravn

Special to The Times

July 14, 2008

http://www.latimes.com/features/health/la-he-closer14-2008jul14,0,3598814.story

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 , 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, " 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.)

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,

Seq, 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 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

s 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 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. 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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