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Monday, July 28, 2008

Should Genetic Tests Be Regulated?

Time magazine reports that although a federal advisory committee in April recommended increasing federal regulation of genetic testing and creating a mandatory online registry of all laboratory genetic tests performed, no action has been taken yet.  Sarah Lynch questions whether genetic tests should be regulated in this booming industry.  Lynch writes,

Genetic_testing6When the human genome was decoded and the achievement breathlessly announced in 2003, a new race was launched: Who would be the first to make this trove of genetic information practically useful — and profitable?

So far, at least 30 direct-to-consumer testing companies have answered the call, analyzing genetic information for curious consumers at anywhere from several hundred to several thousand dollars a pop. (One company charges $350,000 for whole-genome sequencing.) The services range from paternity and ancestry tests to risk assessments for specific diseases, such as breast cancer and Type 2 diabetes. Some tests look for single genes associated with disorders (baldness, in the case of HairDX); others, like 23andMe, one of the industry leaders, use a DNA chip to scan the entire genome in search of single nucleotide polymorphisms, or SNPs — genetic variants that help determine risk for disease or likely traits such as eye color.

Currently this booming direct-to-consumer industry operates with little federal oversight and few industry guidelines. But the popularity of the genetic tests has snared the attention of state and federal regulators. A report released by a federal advisory committee in April recommended increasing federal regulation of the tests and creating a mandatory online registry of all laboratory genetic tests performed, but no action has yet been taken.

Meanwhile, representatives of leading companies, including 23andMe, Navigenics, deCODE Genetics and DNA Direct, have stepped into the void, launching discussions this month in Washington to devise their own voluntary standards, which they expect will promote integrity among their competitors. The companies said they will collaborate with the Personalized Medicine Coalition (PMC), an educational nonprofit, to create the guidelines. They plan to present a draft of the new rules at a PMC conference in December, says Edward Abrahams, PMC's executive director.

The objective is to standardize methods for validating genetic tests and guaranteeing accuracy and quality, says Mari Baker, CEO of California-based Navigenics. For now, all clinical labs, including those that conduct genetic tests, are regulated by the Centers for Medicare and Medicaid Services, which, under the federal Clinical Laboratory Improvement Amendments (CLIA), governs lab-personnel qualifications, quality-control procedures and proficiency testing. But critics argue that the law needs to be updated to include standards for genetic-testing labs. CLIA requires independent evaluations of labs' test-performance proficiency, for example, but genetic-testing labs are exempt from this rule, according to the Genetics and Public Policy Center at Johns Hopkins University.

The industry consortium's voluntary guidelines will also address consumer privacy and transparency and encourage companies to be up-front about the limitations of genetic-risk information, says Baker, who is hoping to model the new guidelines on her company's official standards of practice. She envisions that companies' adherence to the rules will serve as a "Good Housekeeping seal of approval" to help consumers identify the "quality players" in the field.

"This information is new," Baker says. "People need to be able to compare and understand who's doing this the right way. Right now it's too hard to figure that out."

Indeed, even government regulators can hardly figure it out. In June, after receiving complaints from consumers, the California Department of Health sent cease-and-desist letters to 13 companies, including deCODE Genetics, 23andMe and Navigenics, asking them to stop doing business with California customers until they could prove they were complying with state laws. In California, only physicians may order lab tests, and all labs must obtain a state license and meet federal CLIA requirements. Last November, New York State's Department of Health mailed similar letters to 31 companies. (Navigenics and 23andMe have since submitted business plans to New York for approval.) "Our priority is to protect the health and safety of New Yorkers," says Jeffrey Hammond, a spokesman for the department. "Our concerns are about patient safety. These online tests raise the question: What will patients do with this information, and is the information accurate?"

Those questions fuel the debate over whether the information amounts to medical advice. Many doctors say it does. Most companies, including 23andMe, disagree; they say they are simply offering customers genetic information that already belongs to them. If so, how useful is that information? Again, many doctors say it's still far too early to gauge its benefit, because consumers are not capable of interpreting their genetic information or making any meaningful changes in lifestyle or health based on it. In January, Dr. Jeffrey Drazen, editor of the New England Journal of Medicine, co-authored a commentary questioning the tests' value as well as their clinical validity. "We don't think this is ready for common people to use it. Most of the time, it doesn't help you very much, because there isn't much you can do about it," Drazen says. "If they do your test and say you are at a low risk for heart disease, does that mean you should be on a program of sloth and gluttony?"

What's more, the tests don't always offer consistent results. Linda Avey, co-founder of 23andMe, says consumers have received conflicting results from different companies. That can happen for various reasons: not all tests read the same SNPs to calculate the same risk, and not all risks are calculated using the same metric (some results compute the risk of cancer over a lifetime, for example, while others may assess the risk within a 10-year window). "We want to come together as scientists and say, Here's how we should present the information to the consumer," says Avey, who hopes the proposed voluntary industry guidelines will promote consistency among results offered by all companies that read SNPs. "And that way, when they get results back from the different companies, it's more similar."

Kathy Hudson, director of the Genetics and Public Policy Center at Johns Hopkins University, says establishing industry standards is a step in the right direction but thinks the Federal Government should regulate the industry as well.

"I think that industry or professional standards are really important, and in the absence of clear, coherent state and Federal Government oversight, there is an even more important role that industry guidelines can play," Hudson says. "The [drawback] of industry or professional guidelines is that they are voluntary."

Meanwhile, the U.S. Food and Drug Administration (FDA) has declined to discuss what it may have in store for the genetic-testing industry except to say it's definitely on the regulators' radar. Currently the FDA has chosen not to oversee laboratory-developed tests like these, although it has discretion to do so.

"Of course we are watching this field with great interest," says Dr. Steven Gutman, director of the Office of In Vitro Diagnostics at the FDA.

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