Direct-to-Consumer DNA Tests Face Scrutiny Amid Big Sales Push

The skies have been clearing for companies that traffic in direct-to-consumer (DTC) genetic tests lately. After years of stern regulation, the FDA finally approved a genetic health risk (GHR) assessment from industry leader 23andMe in the spring, freeing them to provide more than just ancestry information. And just a few weeks ago, the FDA announced that it was looking to streamline how it evaluates and approves such tests.

Despite the seemingly positive turn of events, the industry still faces plenty of critics. That was evidenced this week, when Senator Chuck Schumer (D-NY) held a press conference in which he called for increased scrutiny on the industry. He requested that the Federal Trade Commission evaluate the privacy policies of companies that sell DTC genetic and ancestry tests.

Schumer’s main point of concern was over how companies might use the extensive amount of genetic data that they gather from customers.

“What those companies can do with all that data—your most sensitive and deepest info, your genetics—is not clear, and in some cases, not fair and not right,” he said. He was careful, though, to point to the newness of the industry rather than any nefarious intent.

The Senator did not raise specific examples, but a recent Gizmodo exploration of test privacy policies found that consumers may sign away more than they know when shipping off their saliva.

AncestryDNA’s policy, for example, says that by submitting DNA to the company “you grant AncestryDNA and the Ancestry Group Companies a royalty-free, worldwide, sublicensable, transferable license to host, transfer, process, analyze, distribute, and communicate your Genetic Information for the purposes of providing you products and services.”

Representatives from most of the companies deny selling data to third party companies. Kate Black, corporate counsel for 23andMe, told NBC News that “customers are in control of their data—customers can choose to consent, or not to, at any time." At a recent Department of Health and Human Services symposium on digital privacy, Black explained how the company is piloting methods to make customers more aware of what they are consenting to, such as splitting validation forms into multiple pages rather than a single slab of text.

It is true that 23andMe does uses genetic data for drug development purposes. In recent years, the company launched its own therapeutics arm headed by former Genentech executive Richard Scheller to leverage the valuable trove of genetic data it has compiled. As the products grow increasingly popular, scrutiny of such activities may be inevitable.

Despite the DTC DNA testing companies have stepped up television advertising in advance of the busy holiday season. Schumer’s press conference Sunday was timed to precede Cyber Monday, during which many tests were available at discounted rates. The Senator could just as well have been speaking in reaction to Black Friday: Out of hundreds of millions of products available on Amazon, 23andMe’s combined health and ancestry test was among the 5 best-selling that day.