The Walgreen pharmacy chain has halted plans to start selling home gene tests until after US Food and Drug Administration (FDA) officials complete their investigation into whether the kits made by Pathway Genomics require regulatory approval.

In a letter dated 10 May, James Woods, deputy director of patient safety and product quality for the FDA’s medical device division, wrote to Pathway CEO James Plante that the company’s saliva collection kit “appears to meet the definition of a device.”

“FDA believes we have regulatory authority over these laboratory-developed tests, but we recognize we have not always used this authority,” Erica Jefferson, an agency spokeswoman, told WebMD.

The agency, it seems, is finally starting to act.

Last year, I attended a workshop on gene test kits at the US National Academies in Washington, DC, where Courtney Harper, the FDA’s acting director of chemistry and toxicology devices, told me that the agency hasn’t regulated genetic tests largely because of “historical reasons.” In the past, clinicians tended to walk down the hallway and order laboratory tests from their resident diagnostic scientists. With the growth of the internet and direct-to-consumer advertising, “the playing field today is not the same as when these practices started,” Harper said.

But industry advocates have defended their kits as purely recreational. “In and of itself, this is not a diagnostic tool,” Elissa Levin, director of genetic counseling at Navigenics, a Foster City, California-based company, said at the workshop. “It’s a comprehensive way to get information,” This sentiment was echoed by David Becker, chief scientific officer of San Diego-based Pathway Genomics: “We don’t feel that we’re practicing medicine.”

Whether the FDA’s letter to Pathway executives this week means that agency will act any time soon remains to be seen. In the meantime, start-ups in genetic testing may be left to their own devices.