Last month, the US Food and Drug Administration (FDA) sent letters to five commercial providers of direct-to-consumer genetic tests, stating that the companies' devices must receive regulatory approval before they can be marketed. The move, which stops short of requiring the tests to be pulled from the market, may eventually increase consumer trust, but it could curtail current research.

“If [the companies'] ability to acquire genetic information slows down, their research may be slowed,” says Geoff Ginsburg, director of the Center for Genomic Medicine at the Duke Institute for Genome Sciences & Policy in Durham, North Carolina. “The FDA process could put some sand in the gears.”

For example, Mountain View, California-based 23andMe, known for its consumer-driven research programs, is currently gathering volunteer user survey data about migraine headaches for an association study to pinpoint genetic variations associated with the condition. If a drawn-out regulatory battle ensues, this research could be put on hold.

But Elissa Levin, director of genomic services at Navigenics, a Foster City, California-based company also cited by the FDA, says the ruling should not affect Navigenics's ongoing investigations. The company is currently partnering with academic centers including the Scripps and Mayo Institutes to explore whether personal genomic testing can be used as a primary research discovery tool. “We don't see any reason why there should be any impact our existing relationships,” Levin says. “These are all [Institutional Review Board] approved studies and these are all research collaborations.”

Research at deCODE genetics should similarly be minimally affected, according to Kári Stefánsson, the company's chairman and president of research. Since deCODE was first founded in 1996, the Icelandic company—also on the FDA's watch list—has maintained an active research program, including a genetic and medical database of more than half the adult population of Iceland. But the company does not use results from their consumer genetic test for research purposes, notes Stefánsson. “We've been doing research in this field for a long time, and we will continue to do so,” he says.

The two other companies to receive letters are Knome and Illumina, based in Cambridge, Massachusetts and San Diego, California, respectively. Knome provides whole-genome sequencing to individuals, including researchers, and Illumina sells a human DNA array used by both 23andMe and deCODE genetics. Academics pursuing research with such platforms should not be affected by the FDA decision, predicts Ginsburg.

Although FDA regulation of direct-to-consumer genetic tests may seem like a barrier now, the added oversight could prove a boon to the industry in the long run, many scientists believe. “The recent activity by the FDA is a welcome step for all concerned,” says Jim Evans, a medical geneticist at the University of North Carolina at Chapel Hill and editor-in-chief of the journal Genetics in Medicine. “[Research] will thrive only in an arena in which tests and the claims made for them can be trusted.”

Stefánsson agrees. “It's going to increase the credibility of the field,” he says. “In the end, I think this is good news for those who want to do this testing and believe in the quality of what they're doing.”