Skip to main content

FDA tells Google-backed DNA test startup 23andMe to halt sales

A 23andMe kit
23andMe

The company that offers customers the ability to uncover genetic health risks for only $100 has been asked to stop selling its main DNA testing kit by the Food and Drug Administration due to is failure to obtain “marketing clearance or approval” from federal regulators.

23andMe, a Google-backed genetics analysis company co-founded by Anne Wojcicki, ex-wife of Google co-founder Sergey Brin, sells a “DNA Spit Kit” that’s used to provide users with detailed reports on more than 250 “health conditions and traits,” including risks of Parkinson’s, heart disease, Alzheimer’s, cancer, and hundreds more. 23andMe also claims that its DNA Spit Kit can also help users know how they will respond to particular drug treatments.

In a letter sent to the company last week, however, the FDA says 23andMe must halt sales of this product, which is also known as a “Saliva Collection Kit and Personal Genome Service,” or PGS, without full approval from the agency.

“FDA is concerned about the public health consequences of inaccurate results from the PGS device,” wrote the agency. “The main purpose of compliance with FDA’s regulatory requirements is to ensure that the tests work.”

23andMe has met extensively with the FDA – “including more than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications,” according to the agency – and submitted to some FDA reviews of its devices. But it has thus far “failed to address” a number of issues regarding the sale and marketing of its DNA test kits and genetics analysis services.

In response to the FDA’s order to halt sales, 23andMe says it plans to work with the agency to ensure all its demands are met.

“We recognize that we have not met the FDA’s expectations regarding timeline and communication regarding our submission,” a 23andMe spokesperson told Digital Trends in an email statement. “Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns.”

At the time of this writing, the $100 DNA Spit Kit is still for sale on the company’s website.

Editors' Recommendations

Andrew Couts
Former Digital Trends Contributor
Features Editor for Digital Trends, Andrew Couts covers a wide swath of consumer technology topics, with particular focus on…
This AI cloned my voice using just three minutes of audio
acapela group voice cloning ad

There's a scene in Mission Impossible 3 that you might recall. In it, our hero Ethan Hunt (Tom Cruise) tackles the movie's villain, holds him at gunpoint, and forces him to read a bizarre series of sentences aloud.

"The pleasure of Busby's company is what I most enjoy," he reluctantly reads. "He put a tack on Miss Yancy's chair, and she called him a horrible boy. At the end of the month, he was flinging two kittens across the width of the room ..."

Read more
Digital Trends’ Top Tech of CES 2023 Awards
Best of CES 2023 Awards Our Top Tech from the Show Feature

Let there be no doubt: CES isn’t just alive in 2023; it’s thriving. Take one glance at the taxi gridlock outside the Las Vegas Convention Center and it’s evident that two quiet COVID years didn’t kill the world’s desire for an overcrowded in-person tech extravaganza -- they just built up a ravenous demand.

From VR to AI, eVTOLs and QD-OLED, the acronyms were flying and fresh technologies populated every corner of the show floor, and even the parking lot. So naturally, we poked, prodded, and tried on everything we could. They weren’t all revolutionary. But they didn’t have to be. We’ve watched enough waves of “game-changing” technologies that never quite arrive to know that sometimes it’s the little tweaks that really count.

Read more
Digital Trends’ Tech For Change CES 2023 Awards
Digital Trends CES 2023 Tech For Change Award Winners Feature

CES is more than just a neon-drenched show-and-tell session for the world’s biggest tech manufacturers. More and more, it’s also a place where companies showcase innovations that could truly make the world a better place — and at CES 2023, this type of tech was on full display. We saw everything from accessibility-minded PS5 controllers to pedal-powered smart desks. But of all the amazing innovations on display this year, these three impressed us the most:

Samsung's Relumino Mode
Across the globe, roughly 300 million people suffer from moderate to severe vision loss, and generally speaking, most TVs don’t take that into account. So in an effort to make television more accessible and enjoyable for those millions of people suffering from impaired vision, Samsung is adding a new picture mode to many of its new TVs.
[CES 2023] Relumino Mode: Innovation for every need | Samsung
Relumino Mode, as it’s called, works by adding a bunch of different visual filters to the picture simultaneously. Outlines of people and objects on screen are highlighted, the contrast and brightness of the overall picture are cranked up, and extra sharpness is applied to everything. The resulting video would likely look strange to people with normal vision, but for folks with low vision, it should look clearer and closer to "normal" than it otherwise would.
Excitingly, since Relumino Mode is ultimately just a clever software trick, this technology could theoretically be pushed out via a software update and installed on millions of existing Samsung TVs -- not just new and recently purchased ones.

Read more