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FDA orders Google's DNA test startup, 23andMe, to stop all sales

23andMe receives a cease and desist order from the FDA forcing a halt of all sales due to lack of approval.

@CharlesJGantt
Published Mon, Nov 25 2013 6:21 PM CST   |   Updated Sat, Aug 8 2020 10:29 AM CDT

Today reports have surfaced that state that the FDA has ordered the Google backed startup 23andMe to immediately cease and desist all sales of its DNA testing kits. The ban on sales is the result of the company failing to obtain "marketing clearance or approval" from federal regulators to sell its product.

FDA orders Google's DNA test startup, 23andMe, to stop all sales | TweakTown.com

The company sells a "DNA Spit Kit" that is used to test a customers DNA and then reports on over 250 health conditions, traits and other genetic identifiers that one might have, or be susceptible to. In a statement, the FDA said that it "is concerned about the public health consequences of inaccurate results from the PGS device. The main purpose of compliance with FDA's regulatory requirements is to ensure that the tests work."

In response 23andMe had the following to say. "We recognize that we have not met the FDA's expectations regarding timeline and communication regarding our submission. Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns."

NEWS SOURCE:digitaltrends.com

A web developer by day, Charles comes to TweakTown after a short break from the Tech Journalism world. Formerly the Editor in Chief at TheBestCaseScenario, he now writes Maker and DIY content. Charles is a self proclaimed Maker of Things and is a major supporter of the Maker movement. In his free time, Charles likes to build just about anything, with past projects ranging from custom PC cooling control systems to 3D printers. Other expensive addictions include Photography, Astronomy and Home Automation.

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