posted at 18:50
Author: Mark Sullivan
Thu, 31 Jul 2014 01:34:15 +0000
23andMe gets a $1.4M NIH grant, still awaits FDA approval
Late last year the FDA barred 23andMe from dispensing health information products to consumers based on analysis of their DNA. Novel associations, especially with the rare genetic variants found by 23andMe, will be of great value for disease prediction, drug development, and biological understanding, 23andMe believes. What everybody wants to know is whether or not the Food and Drug Administration will permit 23andMe to get back into the health genetics business. Epstein Becker Green attorney Brad Thompson warns that the NIH's decision to make the grant says nothing about 23andMe's progress with the FDA. Thompson isn't suggesting that the FDA looks poorly on 23andMe - quite the opposite. 23andMe's Afarian told VentureBeat that the communication breakdown was more the result of her company not knowing exactly how and when to communicate with the FDA. 23andMe is tightlipped on the timing of the FDA's approval of its first health product since the warning letter last year, a predictor for a rare but serious inherited condition called Bloom syndrome. In the meantime, 23andMe spokeswoman Catherine Afarian says, even though consumers can no longer get personal health DNA analysis information back from 23andMe, they continue to provide health information to the company via the online surveys.

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