I have been following the DTCG and FDA closely and it appears, my theory and logic is correct!
23andSerge has decided to stop being silly and stop fighting "The Man" Instead they kiss the ring and FINALLY acknowledge what I have said over and over again. If you are testing for medical conditions, if you are doing medical tests, you must be regulated as such.
Despite this, Anne W and 23andSerge fought for years. "It's research" "It's for fun" "It's not medical"
Further, 23andSerge's move proves the "brilliant" Thomas Goetz dead wrong and me, the little "ol Sherpa, spot on correct.
23andSerge will be asking for FDA approval of their medical device known as the 23andMe test.
Why does a service like this need FDA oversight? Because it is a medical device. Simple enough. Also, oversight is needed for this service as they cannot be trusted to police themselves.
Further, with inaccurate information, the FDA will have a very close look at what 23andSerge is offering.
IMHO, this move by 23andSerge is exactly what is needed to prove to all the skeptics wrong. 23andMe is doing medical testing and needs to be regulated as such. END OF STORY.
The Sherpa Says: I hate to say I told you so. But, I did. Just like I warned the guys at Pathway not to launch DTC via a major retailer. They did 2 weeks later and then got shut down.
Hiç yorum yok:
Yorum Gönder