DNA Analysis, Direct To You
Staff Writer
It had big-money marketing written all over it. Every detail in the Soho gallery space was futuristically sleek and designed to impress the New Yorkers who, the company hoped, would be sold on shelling out $2,499 to get their DNA tested for 18 disease predispositions — but only after they enjoyed fresh pomegranate juice or a “Navitini,” a cocktail created for the occasion. Munching on healthy hors d’hoevres, several dozen people milled among the computer monitors showing Navigenics videos of happy customers. The glam marketing reflected the more than $26 million put into Navigenics by its private equity investors even before it launched in mid-April with 10 days of parties and panel discussions in the Soho space. Half-page ads in The New York Times promoted the events, and former Vice President Al Gore, whose son-in-law is a lead investor, spoke the first night. Navigenics is the latest player in a whole new world — DNA analysis being sold directly to consumers. Calling itself “a personalized genetic health services company,” Navigenics is a Redwood, Calif.-based company founded by Los Angeles-based prostate oncologist Dr. David Agus and geneticist Dietrich Stephan. There are at least two dozen companies in the country now offering genetic testing of one disease or another, like breast cancer or Alzheimer’s, directly to consumers. Navigenics joins 23andMe.com and DecodeMe.com in analyzing genetic material for predispositions for a panel of different diseases and disorders, from obesity and osteoarthritis to heart attack, lupus and multiple sclerosis. The companies charge between $999 and $2,499 for their services, which are not covered by insurance. Customers buy the product online and send in their saliva in special test tubes. The DNA is extracted from the saliva. Navigenics analyzes the DNA for markers that indicate a predisposition to 18 different diseases and conditions. But, as with all of these direct-to-consumer DNA testing services, the results are not predictive. They show statistical correlations rather than indications that the customer will (or will not) get each specific disease. The resulting report says that customer A, for example, has a 20 percent increase in risk for developing prostate cancer, say, or a 65 percent decrease in risk for celiac disease. Little is known about most of these genetic markers, about the interplay of other genes and about environmental factors in triggering the diseases, experts say. “The model is quite different than anything out there before,” said Michael Watson, executive director of the American College of Medical Genetics. His organization, which has some 1,600 members, recently issued a statement that essentially objects to direct-to-consumer genetic testing. Genetic counselors and other experts in the field — including the New York State Department of Health — object to the way these companies are doing business. “Genetic testing is getting easier and easier” in terms of the technology, said Watson. “Unfortunately, the clinical interpretation is, if anything, getting harder and harder. The more complex the genetics of a condition, the more difficult the clinical interpretation. We know the patient’s history and family history. That’s quite different from this model that we’re seeing now.” The extensive advertising being done by the direct-to-consumer DNA testing companies “is premature,” said Dr. Harry Ostrer, director of the human genetics program in the pediatrics department of New York University Medical Center. These companies “are all doing the same thing, using DNA arrays and applying them to clinical testing. The biggest problem I have with it is that the observations aren’t medically validated yet. It’s incomplete knowledge. “People are disappointed, asking what do they do with this information. If they’re told that they have a 20 percent increase in risk for colon cancer, from 5 to 6 percent, what does that mean?” Ostrer said. New York’s Department of Health recently sent a desist letter to 26 companies doing direct-to-consumer marketing, including Navigenics. The state requires that a lab have a New York State permit if it wants to accept samples from state residents, that the patient be billed directly, and that a doctor order the test. Health Department spokesperson Beth Goldberg said, “We have concerns about laboratories like these. Patients, when they get the results, may seek unnecessary treatment. We’re concerned about how patients may react when they receive information that they may not have anticipated, and it places an undue burden on physicians when patients present them with this information.” Navigenics’ Agus said that his company is working with New York State to get its lab certified, and that “we have New York State-licensed physicians on staff — that’s how you work through this” requirement that the testing be ordered by a doctor. He said that he does not see that as a conflict of interest. “Patients are empowered and have their own ability to do things, whether it be a body scan or heart scan,” said Agus. “If a patient wants to have a laboratory test, they are certainly entitled to that.” In any case, the other 49 states and Washington, D.C., allow their residents to become Navigenics customers, he noted. “Certainly we’re working with New York State and don’t envision there being a problem.” Navigenics encourages people to bring their DNA analyses to their personal physicians for discussion. All of the findings are “actionable,” said Agus in an interview while he was in Soho. For example, his own testing revealed an 80 percent chance of developing heart disease in his lifetime. He had borderline-high cholesterol as it was, so he went on a cholesterol-lowering drug. But, says Ostrer, “everyone knows that diet and exercise are important. Beyond that, for most things, “there’s no proof that a $1,000 array will alter your behavior over a sustained period of time.” Genetic counselors say that the results of these genetic analyses are presented in a vacuum, without the context and expertise provided by a personal relationship with a genetic counselor. (Navigenics and DecodeMe offer telephone genetic counseling). Seeing an internist — without consulting a genetic counselor — can be problematic because the internists often don’t have the expertise to know how to follow up on the results of genetic testing, they said. “[Internists] don’t necessarily appreciate what the implications are, and when you have genetic testing you need to have an understanding of what the potential benefits and drawbacks are before you do it,” said Elsa Reich, a genetics counselor in the department of pediatrics at NYU Medical Center. “You need to understand what the choices are, and a lot of physicians don’t take the time to explain that.” Reich had one patient who was positive for the BRCA gene say that her sister’s doctor had said that the sister did not need to be tested for the gene, because she had already had breast cancer. “That is totally incorrect,” Reich said. Many people get breast cancer who do not have the BRCA mutation, so having had cancer is not itself indicative. And having the genetic mutation, or not, has implications for other family members. “These are things a patient needs to understand, and it’s not clear to me that they get it from their physician or from sending in a kit themselves,” she said. Complicated questions and ethical dilemmas may present themselves as a result of genetic testing. What does sharing — or withholding — information about an inherited disease or marker mean for siblings, parents and children? NYU’s Reich, the genetics counselor, also said that despite the slick Web sites the direct-to-consumer DNA testing companies have, saying that something is easy to understand is “a very relative thing. It’s very easy for people not to understand, irrespective of how supposedly simple it is,” she said. “There’s been a lot of paternalism in our field.” According to Navigenics’ Agus,“This is a whole new field, where we’re making it available to you. Consumers have to push for this change.” “This marketing to consumers is here, it’s a done deal, and there’s very little oversight” of it, said Reich. “We should be taking this very seriously. “Probably I do have a conflict of interest too, but not when it comes to the testing itself. I don’t have a vested interest in someone doing testing. I have a vested interest in someone understanding whether or not they should have genetic testing and understanding what the consequences may be.” This new market of direct-to-consumer genetic testing seems to have limitless potential. Being a privately held company, Navigenics officials will not say how many people have ordered its product safer, or if sales are meeting projections. Right now, experts say, the market is constrained only by the product’s high price. As the market expands, “the utility will go up and the price will come down,” said Agus. “But it’s a new market. You don’t know how things are going to grow.”

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11/11/2009 - 11:13

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