Something ’s not quite ripe about 23andMe ’s DNA psychoanalysis kits , and the Food and Drug Administration is on it . The agencyordered 23andMe to block selling the kitsuntil the Google - backed ship’s company can prove that they really work . Sounds sensible .
The authorities did n’t moderate its wordsin a November 22 letter to 23andMe . “ FDA is interested about the public wellness consequences of inaccurate results from the PGS gimmick , ” the letter of the alphabet reads . “ The independent aim of compliance with FDA ’s regulatory requirements is to ensure that the trial work . ” The FDA went on to suggest that false positive degree or false negatives on the test could moderate to startling consequences — like women getting unnecessary mastectomy . People take these tests seriously !
https://gizmodo.com/looking-into-my-genome-reveals-risks-i-ll-never-unsee-5524729
mental rejection about 23andMe ’s Saliva Collection Kit and Personal Genome Service is not a raw affair . In 2012 , UnitedHealth Grouppublished a theme expressing concernabout the accuracy and affordability of 23andMe ’s kits . The report also outlined what a money-spinner the trial could be and forecast that genetic tests could soon be a $ 25 billion one-year market in the United States alone . With so much money on the phone line , you ’d expect these DNA psychometric test to work , but you could also see why a ship’s company might want to rush to food market with a potentially mega - protifable product , even if it ’s not yet perfect .
Now the ball is in 23andMe ’s courtyard . Back in July , whensome concerns were first raisedabout the accuracy of the tests , the company ’s father Ann Wojcicki ( who happens to be Google founder Sergey Brin ’s wife ) bring out a command . “ 23andMe is working proactively with the FDA to insure the industriousness delivers high-pitched timbre information that consumers can trust , ” she said . But is n’t that what they should ’ve been doing since they launched six long yr ago ? [ FDAviaBloomberg ]
Update ( 2:18 p.m. ): A voice from 23andMeissued the following statement :
We have received the monition letter of the alphabet from the Food and Drug Administration . We recognize that we have not encounter 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 to the full engaging with them to address their concerns .
Image via Flickr /kyz
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