Replies to post #18932 on Radient Pharmaceuticals Corporation fka RXPC

[jimtash]

23andme was shut down because they failed to register their test kit as a medical device. On top of having pressure by other interests seeking to sell similar tests on the market.

Onko Sure/DR 70 is or was registered as a medical device by the FDA. So Gartner can indeed sell the kits because they're already classified by the FDA.

23andMe has previously submitted applications to the FDA in an attempt to get their devices approved, but the FDA said those failed to address issues that have come up before between it and the company. There's also the spectre of vested interests looming over this case, however: The biggest U.S. health insurer in operation raised a stink about 23andMe's tests back in 2012. 23andMe has identified a massive, lucrative market opportunity and there's good reason for insurers and others to want a say in how the money shakes out

http://techcrunch.com/2013/11/25/23andme-fda-block/

[Gold Seeker]

GenWay sold the test as a cancer screen, not just lab use. They had a website called "youtestyou.com"

They were selling it off label and I never saw any letter from the FDA shutting them down. What did happen was obvious though... They never sold many tests at all.