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But should the FDA be more vigilant? Most genetic tests–including those given by doctors–are subject to the FDA’s medical-device regulations. There are three classes of medical devices, each requiring an increasing degree of regulatory control. Depending on the nature of the test and what reagents are used to produce the results, the consumer genetic tests may or may not require premarket approval, though they must include a disclaimer stating that they have not been cleared by the FDA. The agency’s discussions with Pathway and its rivals may result in more such cautionary language being displayed prominently on packaging and consumer leaflets.

Some genetics experts believe consumers need even more comprehensive information about the limitations of genetic testing. They point out that scientists have not yet decoded the genetic causes of most diseases and many uncertainties surround genetic testing.Take BRCA1 and BRCA2, for example. While mutations in these genes have been linked to breast cancer, less than 10 percent of women who develop the disease actually test positive for the genes. For other diseases, such as Alzheimer’s, very few genes have been linked to the illnesses, and it’s unclear how important those genes are in the diseases. So genetic tests might create unwarranted fear in some patients, says Hope Northrup, director of the Division of Medical Genetics in the Department of Pediatrics at the University of Texas Medical School at Houston.

Edward McCabe, codirector of the Center for Society and Genetics at the University of California at Los Angeles, believes consumers who buy genetic tests–either online or on store shelves–should be instructed on exactly what each result can accurately predict and what it can’t. The FDA should have the authority to vet the tests, as well as the information that comes with them, he says. “Otherwise inappropriate health-care decisions could be made.”

The FDA and Congress are unlikely to outlaw the marketing of genetic tests to consumers altogether, most experts believe. But Vorhaus predicts they will put pressure on the U.S. Federal Trade Commission to monitor the messages that these companies are giving to consumers.

In any case, the fact that these agencies are paying attention to genetic testing could be enough to change how Pathway, Walgreens, and other companies communicate the value of their products to consumers. “Shine a bright light on the industry,” Vorhaus says, “and you’ll get the industry to monitor itself.”

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Credit: Pathway Genomics

Tagged: Biomedicine, genetic testing, FDA, Pathway Genomics, Walgreens

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