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

By Andrew Couts November 25, 2013

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.

Recommended Videos

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.

Topics

Emerging Tech

Former Digital Trends Contributor

Features Editor for Digital Trends, Andrew Couts covers a wide swath of consumer technology topics, with particular focus on…

Outdoors

Juiced Bikes offers 20% off on all e-bikes amid signs of bankruptcy

Juiced Bikes Scrambler ebike

A “20% off sitewide” banner on top of a company’s website should normally be cause for glee among customers. Except if you’re a fan of that company’s products and its executives remain silent amid mounting signs that said company might be on the brink of bankruptcy.That’s what’s happening with Juiced Bikes, the San Diego-based maker of e-bikes.According to numerous customer reports, Juiced Bikes has completely stopped responding to customer inquiries for some time, while its website is out of stock on all products. There are also numerous testimonies of layoffs at the company.Even more worrying signs are also piling up: The company’s assets, including its existing inventory of products, is appearing as listed for sale on an auction website used by companies that go out of business.In addition, a court case has been filed in New York against parent company Juiced Inc. and Juiced Bike founder Tora Harris, according to Trellis, a state trial court legal research platform.Founded in 2009 by Harris, a U.S. high-jump Olympian, Juiced Bikes was one of the early pioneers of the direct-to-consumer e-bike brands in the U.S. market.The company’s e-bikes developed a loyal fandom through the years. Last year, Digital Trends named the Juiced Bikes Scorpion X2 as the best moped-style e-bike for 2023, citing its versatility, rich feature set, and performance.The company has so far stayed silent amid all the reports. But should its bankruptcy be confirmed, it could legitimately be attributed to the post-pandemic whiplash experienced by the e-bike industry over the past few years. The Covid-19 pandemic had led to a huge spike in demand for e-bikes just as supply chains became heavily constrained. This led to a ramp-up of e-bike production to match the high demand. But when consumer demand dropped after the pandemic, e-bike makers were left with large stock surpluses.The good news is that the downturn phase might soon be over just as the industry is experiencing a wave of mergers and acquisitions, according to a report by Houlihan Lokey.This may mean that even if Juiced Bikes is indeed going under, the brand and its products might find a buyer and show up again on streets and trails.

Cars

Volkswagen plans 8 new affordable EVs by 2027, report says

volkswagen affordable evs 2027 id 2all

Back in the early 1970s, when soaring oil prices stifled consumer demand for gas-powered vehicles, Volkswagen took a bet on a battery system that would power its first-ever electric concept vehicle, the Elektro Bus.
Now that the German automaker is facing a huge slump in sales in Europe and China, it’s again turning to affordable electric vehicles to save the day.Volkswagen brand chief Thomas Schaefer told German media that the company plans to bring eight new affordable EVs to market by 2027."We have to produce our vehicles profitably and put them on the road at affordable prices," he is quoted as saying.
One of the models will be the ID.2all hatchback, the development of which is currently being expedited to 36 months from its previous 50-month schedule. Last year, VW unveiled the ID.2all concept, promising to give it a price tag of under 25,000 euros ($27,000) for its planned release in 2025.VW CEO Larry Blume has also hinted at a sub-$22,000 EV to be released after 2025.It’s unclear which models would reach U.S. shores. Last year, VW America said it planned to release an under-$35,000 EV in the U.S. by 2027.The price of batteries is one of the main hurdles to reduced EV’s production costs and lower sale prices. VW is developing its own unified battery cell in several European plants, as well as one plant in Ontario, Canada.But in order for would-be U.S. buyers to obtain the Inflation Reduction Act's $7,500 tax credit on the purchase of an EV, the vehicle and its components, including the battery, must be produced at least in part domestically.VW already has a plant in Chattanooga, Tennesse, and is planning a new plant in South Carolina. But it’s unclear whether its new unified battery cells would be built or assembled there.

Cars

Nissan launches charging network, gives Ariya access to Tesla SuperChargers

nissan charging ariya superchargers at station

Nissan just launched a charging network that gives owners of its EVs access to 90,000 charging stations on the Electrify America, Shell Recharge, ChargePoint and EVgo networks, all via the MyNissan app.It doesn’t stop there: Later this year, Nissan Ariya vehicles will be getting a North American Charging Standard (NACS) adapter, also known as the Tesla plug. And in 2025, Nissan will be offering electric vehicles (EVs) with a NACS port, giving access to Tesla’s SuperCharger network in the U.S. and Canada.Starting in November, Nissan EV drivers can use their MyNissan app to find charging stations, see charger availability in real time, and pay for charging with a payment method set up in the app.The Nissan Leaf, however, won’t have access to the functionality since the EV’s charging connector is not compatible. Leaf owners can still find charging stations through the NissanConnectEV and Services app.Meanwhile, the Nissan Ariya, and most EVs sold in the U.S., have a Combined Charging System Combo 1 (CCS1) port, which allows access to the Tesla SuperCharger network via an adapter.Nissan is joining the ever-growing list of automakers to adopt NACS. With adapters, EVs made by General Motors, Ford, Rivian, Honda and Volvo can already access the SuperCharger network. Kia, Hyundai, Toyota, BMW, Volkswagen, and Jaguar have also signed agreements to allow access in 2025.
Nissan has not revealed whether the adapter for the Ariya will be free or come at a cost. Some companies, such as Ford, Rivian and Kia, have provided adapters for free.
With its new Nissan Energy Charge Network and access to NACS, Nissan is pretty much covering all the bases for its EV drivers in need of charging up. ChargePoint has the largest EV charging network in the U.S., with over 38,500 stations and 70,000 charging ports at the end of July. Tesla's charging network is the second largest, though not all of its charging stations are part of the SuperCharger network.