With the U.S. Food and Drug Administration challenging the ethics of 23andMe’s consumer DNA tests, the company announced it will temporarily suspend analysis of health data for new customers. Does that mean the Google (GOOG)-backed startup is likely to change its business model? Probably not. A few things to consider:
23andMe will continue to give customers their raw health data. The mechanics of the actual DNA test haven’t changed. You pay $99, register your kit, spit in a test tube, and mail it off (except in Maryland or New York, which only allow such testing in state-approved laboratories). 23andMe will then send your DNA to its lab partner, which adheres to the same FDA-approved quality standards as any lab that processes physician-ordered tests. Customers will still get a report on what their DNA reveals about their ancestral origins, including what percentage of their DNA comes from Neanderthal stock. They’ll still get raw results, but they won’t learn what health traits are associated with their genes, nor will they be told what diseases they may be more prone to.
The move applies to anyone who bought the test after Nov. 22. That’s when the FDA issued its warning letter to 23andMe Chairwoman Anne Wojcicki, telling her the company must stop marketing the personal genome service. Anyone who ordered the test before that date will get the full slate of results. Those who ordered after that won’t be able to see their health analysis until the FDA matter is resolved.
The FDA is taking issue with the impact of the test, not the test itself. As Alberto Gutierrez, the FDA director who issued the warning, told me: “We don’t have an issue with people getting their own DNA data. We just have concerns with how it’s being interpreted.” Specifically, Gutierrez has pointed to the risk that such tests may stoke misguided fears or inspire users to take drastic actions such as unnecessary surgical procedures after getting the results. A number of critics have taken issue with this stance, saying consumers should have the power to make those decisions for themselves. They point to home pregnancy tests and HIV-testing kits as examples of other over-the-counter medical kits now available without a doctor’s authorization.
How long customers will have to wait to get their health reports is yet to be determined. The company has until Dec. 13 to make a formal response to the FDA warning letter. The FDA then has 90 days to make its response. If the two sides get locked in a legal battle over this issue, the ban could drag on for months.
23andMe is sticking to its business model. Wojcicki and her team believe in the power that personal genomic information can bring both the individual and the health-care industry when that data are pooled for research. That’s why they dropped its price from $999 to $99 and have tried to increase mass-market acceptance of its service through a national ad campaign this fall and an online course with Udacity. It’s why they brought in former Gilt Groupe exec Andy Page as president, who sees the potential for 23andMe to morph into a wider lifestyle and wellness brand. It’s why corporations and insurers are also intrigued by the potential of personal genomics. And that escalating popularity is why the FDA is also stepping up its scrutiny: “Now they’re moving on to people who may not be able to understand these results.”
The FDA’s prudence is unlikely to halt the long-term trend of consumers wanting more data on their health. In an era where an iPhone can perform a hospital-standard EKG and a plastic wristband can track sleep patterns, learning the basics of your genetic profile doesn’t sound so scary to a lot of people (especially those who believe such data could lead to a cure). The FDA is right to make sure that companies like 23andMe are conservative in their analyses, and that consumers are forced to understand what they’re getting. (That’s why the company makes people read some background material to “unlock” certain results.) One such screen is for the BRCA1 and BRCA2 genes, for example. While carriers of those genes may have a genetic predisposition to breast cancer, the test is only a partial screen, and such genes are a factor in only 5 percent to 10 percent of all breast cancer. The next step? See your doctor.
Doctors rule. While many of these devices, tests, and other services may help you stay healthy and deal with ailments in an early, treatable stage, they’re no substitute for medical care. Consumers don’t order up double mastectomies: Health-care professionals do. That’s the way it should be. Seeing a commercial for a cool drug doesn’t mean you can go buy it. Doctors, nurses, counselors, and others are trained to distinguish what we want from what we actually need. Whether they always do is open to debate, but a more informed consumer could be a powerful ally in that process.