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."
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. 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.
The FDA didn’t tell the three companies to stop selling their tests. But the agency pointed out that it considers them medical devices that need regulatory clearance, and asked for justifications if the companies believe the clearance isn’t necessary. "The FDA actively regulates genetic tests sold directly to consumers to make sure they are safe and do what they claim to do," spokeswoman Jennifer Dooren said in an e-mail. "Without FDA oversight, the safety and efficacy of these tests have not been determined and could potentially lead to patient harm."
DNA4Life and DNA-CardioCheck didn’t respond to requests for comment. Mark Carbeau, chief executive of Interleukin Genetics, said the company’s main product, a test that predicts the risk of gum disease, is sold primarily through dentists. Other products "can be purchased by a consumer, though a medical professional needs to be involved,” Carbeau said. "We think, properly done, genetic tests offer real value to the health-care community, and we’re certainly supportive of the FDA’s efforts to protect the public and provide guidance.”
The FDA has cracked down on testing companies marketing straight to the public before. In late 2013, it ordered 23andMe to stop selling its personal genome analysis. This past February, the agency approved 23andMe’s test for a limited use, to detect whether people carry the gene for Bloom syndrome, a rare genetic disorder. The company has since added other approved uses to determine whether people carry mutations that could be passed down to their children.
One of the risks of making genetic tests available directly to consumers is that people may confuse diseases caused by complex risk factors with those caused by a single genetic abnormality. While a single gene mutation can cause cystic fibrosis, “for things like cardiovascular disease that’s just not true," said Michael Christman, CEO of the Coriell Institute, a Camden (N.J.) research center focused on genetic medicine.
Unlike with some rare hereditary conditions, many pieces of a person’s DNA may influence his or her risk for heart disease, cancer, or diabetes, and they’re not all well understood. And genetics are only one risk factor, along with environmental exposures and lifestyle, that helps determine whether someone will get a disease.
In an ideal world, genetic tests would go through physicians or other experts capable of interpreting results, Christman said. “People joke there’s the $1,000 genome followed by the $1 million interpretation,” he said. "The interpretation is complicated, and it needs to be done very well.
Christman said the greatest potential for genetic medicine right now is using DNA profiles to determine how people might react to different drugs or doses, a field called pharmacogenomics. More than 100 drugs have information on their labels about how people with certain genetic markers may respond differently.
The challenge ahead for the FDA is policing the evolving market for genetic testing. "They’re trying to figure out 'How do we help consumers and providers that don’t work in genetics all the time to distinguish what tests are useful and what aren’t?' " said Joy Larsen Haidle, president of the National Society of Genetic Counselors. "What got some of the labs into trouble before with the FDA was you could send a sample of saliva to a couple of different labs and you would get very different results to the same question."