Cautious Evolution Underway in DTC Genetic Testing

Andrew D. Smith
Published: Friday, Feb 12, 2016
Wendy K. Chung,

Wendy K. Chung, MD, PhD

Order online. Spit in a cup. Learn how your genes affect your risk for hundreds of diseases including cancer.

“Direct-to-consumer testing businesses are continuously walking on a fine line, trying to find where the boundaries are,” said Jennifer Wagner, JD, PhD, associate director of Bioethics Research at Geisinger Health System, based primarily in Pennsylvania. “The FDA has tried to regulate DTC genetic tests by interpreting them as ‘medical devices,’ which is a quite a stretch, legally... From a technical standpoint, it has not forbidden DTC testing, but from a practical standpoint, it has scared many companies away from that business model.”

Initial Advances

DTC genetic tests first hit the market more than a decade ago as technologies to analyze the human genome advanced. They remained a niche item, however, until November of 2007, when the publicly traded company deCODE Genetics and the Google-backed startup 23andMe began selling tests. Navigenics followed soon afterward. These high-profile companies attracted widespread media coverage that introduced the “spit kit” concept to the American public and brought a few more competitors into the market.
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