Validating new trends in genetic testing

Dec. 19, 2015
There are some controversial testing trends happening in the genetic test market. As clinical laboratory professionals, should we be prepared to embrace these trends? Will some of these online easy, one drop, technologies affect our future? Is anyone out there questioning the science or looking for standards to validate these offerings?

The controversial direct-to-consumer genetics testing company 23andMe, which has had its misadventures with regulators since its founding in 2006, is addressing potential customers via a slick new television advertisement.

Soft, pleasant music plays throughout the minute-long ad. Images of people of different ages and races appear on screen (all of them with a genetic predisposition, apparently, to being slim and attractive, with good teeth). The copy is read by a cheery female voice: “This is a story. About you. The incredible you. It starts with your DNA, your twenty-three pairs of chromosomes, that make you unique—your traits, your tastes. This is a story about why you became who you are. 23andMe dot com is the first and only genetic service available directly to you that includes reports that meet FDA standards. You’ll get personalized, detailed reports that provide unique insights into your health, traits, and ancestry. Simply order your DNA kit from 23andMe dot com, provide your saliva sample at home, and mail it back. Then you’ll be notified when your online reports are ready. You’ll be able to explore your reports and use tools to compare your genetics with friends and family. See how your twenty-three pairs of chromosome help tell the story of one, incredible you. Order your DNA kit today at 23andMe dot com.”

In addition to the parade of appealing would-be customers, images include quick shots of reports on “caffeine consumption,” “lactose intolerance,” “eye color,” and “ancestry composition,” a shot of the saliva-collection device, and, finally, a few images of people viewing their “online reports” on laptops.

The ad copy is skillfully written; it pushes the right rhetorical buttons. It appeals to narcissism, telling viewers how incredible and special they are. The words you, your, and you’ll are spoken 22 times. It stresses how easy the whole process is, while alluding to the science of genetics that underlies the product as little as it possibly can. It conveys the message that what is being offered is much more than that “ancestry” stuff the viewer might see in other commercials—while at the same time suggesting that it includes that too, for viewers who want that. And, almost as an aside, it mentions “reports that meet FDA standards.”

That seems to suggest a blanket endorsement by the government agency but, in fact, glosses over the checkered history of 23andMe. It leaves out the fact that, in 2013, the U.S. Food and Drug Administration ordered the company to stop presenting its product to the public as way of assessing disease risk. The FDA underscored its displeasure by publicly releasing a letter criticizing the company for failing to respond to the agency’s concerns in a prompt manner. After that, 23andMe continued to sell a personal genome test, but without a health component.

Some fence-mending has occurred in the meantime, culminating in the FDA’s decision last February to approve the company’s test for a genetic variant linked to Bloom syndrome, a rare autosomal disorder. 23andMe has not been cleared to give information related to Alzheimer’s or breast cancer, or information that predicts drug response, as it did before the 2013 FDA ruling.

23andMe is characterizing its partial return to the FDA’s good graces as a victory and its resumption of selling its health-risk component as a triumphant relaunch. The feel-good ad is part of that. Direct-to-consumer genetic testing may in fact be a wave of the future, and 23andMe may be a major player.

But American consumers should not be misled by clever advertising that oversimplifies a complex situation—and should not make medical decisions based only on information they receive from 23andMe. And clinical lab professionals should watch the story closely: if consumers increasingly use services like this to predict and try to prevent health problems, that has implications for the industry and for public health.