Are Genetic Tests Useful Part 4

Feero was the lead author of a commentary in the 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."

You 2.0 Series Comparison Shopping for Your Future Part 1: Personal genetic tests are proliferating; some are even online. Do they really tell you anything? I'm Doomed. Or Not. Part 2: Commercial genetic tests tell me I have high, medium, and low risk of heart attack. What gives? Recreational DNA and Genetic Voyeurism Part 3: Are there really genes for sprinting and bitter taste? A comparison of genetic traits from new online DNA testing sites.

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 saliva in a mail-in container, isolate your DNA, and, through a secure website, will tell you about attributes ranging from restless legs 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 Nondiscrimination 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 Senator Barack Obama, the Illinois Democrat running for president, and the other by Senator Edward Kennedy, a Democrat from 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.