(Bloomberg) — DNA4Life offers a $249 test to help customers understand whether their genes put them at risk of having bad reactions to more than 100 common medicines. Interleukin Genetics sells a $169 test that “may help you lose more weight by properly matching diet and exercise plans” to genetic profiles. And DNA-CardioCheck has suggested its test, at $450, is a “reliable method to determine whether or not you might be at risk for developing blood clots which might result in cardiovascular disease.”
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All three companies got letters from the Food and Drug Administration in early November suggesting they didn’t have the proper clearance to sell medical tests to consumers. It’s the latest sign that regulators are concerned about how companies market DNA tests for health insights, sometimes bypassing doctors entirely.
There’s good reason for that worry: For most people, the genetic analysis available today doesn’t provide much meaningful health information at all.
DNA tests can reliably establish family ties, like paternity tests, or reveal a person’s ethnic heritage. They can also tell whether people are at risk for certain rare diseases like cystic fibrosis that are directly linked to genetic mutations, or for passing the risk on to their children.
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But when it comes to information relevant to people’s health, especially about common conditions like heart disease or diabetes, the value of genetics becomes much murkier.
“Right now, almost all of this is premature and not terribly useful to individuals,” said George Annas, a Boston University bioethics professor and co-author of Genomic Messages, a book about how genetics is changing medicine. “It’s complicated, and these testing companies are trying to make it appear that it’s much more simplistic so they can sell you a product.”
Companies see a gold mine in turning genetic data into information people can use to stay healthy or battle illness. A few years ago, Booz Allen Hamilton estimated that there were nearly 3,000 tests available; market researcher Technavio says the industry is growing by close to 10 percent a year. Many of these tests are available only through health care providers.