[ExI] FDA Clears 23andMe For Health and Carrier Status Testing
dsa at unsa.edu.ar
Wed Oct 21 21:41:12 UTC 2015
Some might draw the similarities between Theranos’ current FDA struggle and
23andMe. The blood test startup valued at more than $9 billion and backed
by the likes of Henry Kissingerrecently came under fire
questions about the accuracy of its test results and the revelation that
its proprietary ‘Edison’ machine currently processed only one of its 240
tests. The startup pulled back under regulatory pressure.
However, GV’s <https://www.gv.com/> Bill Maris doesn’t think that
comparison works. “Theranos is a bit different because you have people
questioning the basis of is it accurate,” he told TechCrunch in a sit-down
interview at the Wall Street Journal Live conference in Laguna Beach,
California. “23andMe’s problem wasn’t accuracy, thankfully. It was the FDA
reasonably saying ‘you’re leading people to make conclusions about their
health. Let’s come up with regulatory information to make sure that you are
providing people with accurate information that’s properly referenced.”
23andMe has reportedly worked extensively with the FDA behing the scenes to
gain approval, including sending head of the company Anne Wojcicki to D.C.
for meetings and hiring a policy director to handle FDA regulatory matters.
Diego.Saravia at gmail.com
NO FUNCIONA->dsa at unsa.edu.ar
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