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You 2.0: Closing the Genetic Gap

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You 2.0: Closing the Genetic Gap
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It's happening again: A new technology and breakthrough discoveries are equipping entrepreneurs with the tools to rattle the status quo.
It occurred 10 years ago when the internet introduced radical new ways to communicate, be subversive, and sell things. Now it's the turn of gene-techs — the fledgling industry that's setting out to mine the DNA inside us.
Their goal: To help us determine who we are, and maybe to provide clues to everything from our ability to taste bitter foods to our proclivity for depression and our chances of having a heart attack.
In just the past year, dozens of genetic markers associated with traits have been coming out of labs at a furious pace as genetic knowledge, technology and computing power has hit a critical mass one decade after the race to sequence the human genome was raging.
The question is: As new, direct-to-consumer genetic testing sites begin delivering this fresh and sometimes incomplete DNA news to customers online, how will Big Medicine and government regulators react? And how will they shape what DNA testing sites look like?
Consumer reaction is crucial, too. But with testing companies charging $1,000 to $2,500 for genetic information that is sometimes incomplete, I suspect that most people who aren't both well-heeled and DNA-curious will wait until prices drop and physicians and regulators catch up.
"The recent explosion of genetic testing has blown the door off the old model of researchers testing one gene at a time and then taking it to the clinic," says W. Gregory Feero, senior adviser to the director of genomic medicine at the National Human Genome Research Institute in Bethesda, Maryland.
"We now have to move much faster to make this information relevant and useful," he continues, adding that more effective oversight is required because the results of genetic tests are being interpreted "all over the map."
Feero was the lead author of a commentary in March issue of the Journal of the American Medical Association about the current state of genetic testing. The article's evocative title: "The Genome Gets Personal — Almost."
The catch up has begun. In just the past month, the effect of these new sites has been felt in two arenas that have been caught off-guard by the advent of commercial genetic tests for healthy individuals: Big Medicine (researchers and health-care providers) and the government.
The new wave of online sites has been led by 23andMe.com in California and DeCode Genetics' DeCodeMe.com in Iceland; both opened for business late last year. For $1,000, either will take your spit in a mail-in container, isolate your DNA, and through a secure website will tell you about attributes ranging from restless-leg syndrome to lactose intolerance. A third major company, Navigenics, began offering its more medically oriented service for $2,500 last month.
Days after Navigenics opened for business, Congress overwhelmingly passed the Genetic Information Non-Discrimination Act, legislation that protects Americans from having insurers and employers use their genetic information against them. The legislation had languished for more than a decade.
My sources on Capitol Hill say that the arrival of direct-to-consumer testing was one of the deciding factors in pushing forward the vote. (President Bush is expected to sign the legislation in the next few days.)
Regulators are also stirring. Last week, an advisory committee at the Department of Health and Human Services called for tighter regulation of consumer genetic tests, warning that they were often marketed with little scientific evidence of their usefulness to individuals.
The panel called for the Food and Drug Administration to require tough evaluation standards to prove the usefulness and validity of these tests, and for a mandatory registry of all laboratory tests.
"There are plenty of tests out on the market now that have essentially had no scrutiny of any type," Marc Williams, a member of the panel and the director of the Clinical Genetics Institute at Intermountain Healthcare in Salt Lake City, told the Wall Street Journal.
Previous attempts by the F.D.A. and others to require more oversight have stalled. It's unlikely that much will be done in the waning days of the Bush administration, though Congress is considering two bills — one co-sponsored by Sen. Barack Obama, the Illinois Democrat running for president, and the other by Sen. Edward Kennedy (D-Massachusetts).
In recent weeks, New York State health officials have written to at least six online genetic testing companies, warning them that it is illegal in their state to offer DNA tests without a physician’s approval. Violations could lead to fines and jail time.
No one has been charged with any violation. California officials are also investigating consumer complaints about online testing companies violating a similar law there.
"We welcome responsible regulation," said David Agus, an oncologist at Cedars-Sinai Medical Center in Los Angeles and the cofounder of Navigenics. "There needs to be medical standards and a system for validating this information."
Feero agrees. "We have relatively little oversight for this information, which you're seeing for yourself with your heart attack results."
(He is referring to my conflicting results for heart attack risk from the three websites. One rated me as high risk, one as low risk, and the other as medium risk. "You should not be getting contradictory results like that," says Feero.)
Universities and medical groups are also taking steps to move into the new age of genomics, with initiatives to improve education for doctors and a flurry of articles and letters in medical and research journals.
Several major medical centers are developing their own tests vetted by scientists and physicians.
Baylor College of Medicine in Houston, for instance, is developing a custom gene-testing array focused on about 10,000 genetic markers associated with diseases. This is different from "off the shelf" arrays used by retail testing services that do not cover many genetic markers associated with disease.
In New Jersey, meanwhile, the nonprofit Coriell Institute for Medical Research is developing a service that will test for a slate of validated genetic markers, and provide free — yes, free — information and analysis for common diseases. The institute plans to sign up 10,000 people in the next two years, and eventually enlist 100,000 people.
The big medical testing companies are also finding a market for offering traditional physician-ordered tests for genetic markers. Quest Diagnostics, for instance, earns $1 billion a year from molecular diagnostic testing, which includes dozens of DNA tests.
DNA Direct has another model, combining some aspects of traditional medical testing with an online service and products ordered over the internet. DNA Direct offers a range of individual, doctor-approved tests that are ordered one at a time, usually when one's family history suggests a test is needed.
Over the next year or two, we are likely to see a mini-version of the dot-com shakeout occur in genetic testing. This is a moment when experimentation with business models will be as varied and edgy as the science itself, which also will continue to rapidly improve the quality of DNA testing and analysis.
But make no mistake: The long-anticipated age of personalized genomics has arrived — perhaps in fits and starts, but it's here. And it will change not only the practice of medicine and how we take care of ourselves, but also may change how we view our health and who we are.
Some of this material for this series is taken from Experimental Man: What One Man's Body Tells Us about His Destiny, Our Health, and Our Toxic World, by David Ewing Duncan, due out in Oct. 2008.

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