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Personal Gene-Testing Companies Need U.S. Clearance, FDA Says

Gene-test kits that promise to tell consumers their risk of Alzheimer’s disease, breast cancer and numerous illnesses must be approved by regulators whether the tests are sold online or in stores, a U.S. official said.

The Food and Drug Administration has grappled with how to regulate a growing number of gene-testing companies in recent years, said Alberto Gutierrez, director of the FDA office that regulates diagnostic tests. The agency now believes developers of the tests are making health claims that must be cleared by the government if their products are to be sold directly to consumers, he said in an interview yesterday.

To date, no such test has been approved or rejected by the FDA, he said. This week’s demand for information from closely held Pathway Genomics of San Diego, which planned to sell its test at Walgreen Co. stores starting today, shows the agency is ready to be more muscular in exercising its authority, said Ira Loss, a senior health policy analyst at Washington Analysis LLC.

The FDA wants “to make sure the public is protected from tests that aren’t accurate or a lack of counseling,” Loss said in a telephone interview.

“You don’t have to think very long to see how people could possibly make poor decisions concerning their future because of a test that doesn’t properly explain things to them.”

Pathway had been marketing consumer gene-tests online before agreeing to sell the product at Deerfield, Illinois-based Walgreen, the largest U.S. drugstore chain. The retailer halted plans to start selling the home-use saliva collection kit after the FDA released a letter May 12 telling Pathway the product appears to be a medical device subject to agency review.

Pathway Comment

A spokesman for Pathway declined to comment after sending a statement that said the company respects Walgreen’s decision and is communicating with the FDA. “Pathway works very diligently to ensure that our business is compliant with all applicable regulations and guidelines,” the statement said.

Some gene tests offer guidance on the probability that would-be parents will pass certain genes linked to diseases on to their offspring. The American Society of Human Genetics said such tests may affect the choice of whether or whom a person marries, the decision to have children and whether to have an abortion.

Navigenics of Foster City, California, 23andMe of Mountain View, California, and DeCode Genetics Inc. of Reykjavik, Iceland, are among the companies that market genetic tests online. Navigenics was invited by the FDA to provide information about its service in May 2009, and believes it complies with all state and federal regulations, the company said in a statement.

Other Makers

23andMe, started in 2006 by Linda Avey and Anne Wojcicki, wife of Sergey Brin, co-founder of Google Inc., declined to comment. Google, the operator of the most popular Internet search engine, has invested at least $6.5 million since 2007 in the company, according to regulatory filings.

Pathway’s test kits offer to analyze customers’ genes for three purposes: to predict what each individual’s risk is for diseases ranging from Alzheimer’s to prostate cancer, to assess would-be parents’ probability of passing on health problems to offspring and to evaluate how the test-taker will respond to certain drugs.

Pathway’s test kit aim to provide information about how customers’ genes affect their risk for developing 26 health conditions and the likelihood of passing any of 37 inherited conditions to unborn children. It also describes how customer’s genes affect their propensity to respond to such drugs as Bristol-Myers Squibb Co.’s blood-thinner Plavix as well as cholesterol-lowering statins such as Pfizer Inc.’s Lipitor.

Fictitious Patient

A 95-page sample report contains some information about a fictitious patient’s risk of Alzheimer’s disease.

“There is no singular test that can definitively diagnose Alzheimer’s disease, but your genetics suggest that you may be vulnerable to having this disease at some point in your life.”

That kind of information won’t help people, said Joanne Boughman, executive vice president of the American Society of Human Genetics in Bethesda, Maryland.

“For a disease like AD, for which there is no intervention or treatment, that isn’t useful information,” Boughman said. “In fact I would consider it info that could be disturbing or distressing and therefore harmful.

“The genetics community has been seeking oversight for more than a decade,” Boughman said in a telephone interview yesterday.

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