Date: Jul 30, 2014 Author: Mark Sullivan Source: Venture Beat (
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Late last year the FDA barred 23andMe from dispensing health information products to consumers based on analysis of their DNA.
But things have brightened up considerably in the nation's capital for the company. 23andMe cofounder and CEO Anne Wojcicki has done well for herself and her company there in 2014. Lawmakers and regulators like and respect her.
23andMe's latest Washing ton win comes in the form of a new grant from the National Institutes of Health (NIH).
The company will use the $1.4 million grant to access the whole human DNA sequence and discover rare variants associated with various types of diseases. Some of it will improve and expand the online survey tools 23andMe uses to gather health and ancestry information from users.
The money will also enable external researchers to access aggregate data from the 23andMe database. "23andMe is building a platform to connect researchers and consumers that will enable discoveries to happen faster," Wojcicki said in a statement yesterday. "This grant from the NIH recognizes the ability of 23andMe to create a unique, web-based platform that engages consumers and enables researchers from around the world to make genetic discoveries."
When and if 23andMe scientists make new connections between diseases and genetic variants (which could be used to predict disease), the company plans to publish its findings in peer-reviewed scientific journals.
Overall, the two-year project will yield a database containing genotypes for 40 million genetic variants and information on thousands of diseases and traits for more than 400,000 individuals. 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.
The NIH is not the FDA
What everybody wants to know is whether or not the Food and Drug Administration (FDA) will permit 23andMe to get back into the health genetics business.
But 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 helps medical device makers and others work with the FDA on compliance issues.
"People tend to lump the federal government altogether and act as though they share one brain, when quite the opposite is true," Thompson says in an email to VentureBeat. "It is a common everyday occurrence that one federal agency might invest in a new technology that another federal agency views with skepticism. So the NIH investment means nothing with regard to FDA."
But Thompson isn't suggesting that the FDA looks poorly on 23andMe -- quite the opposite.
"... You need to appreciate that frankly I think FDA loves the technology; I think that many people at FDA personally believe that this technology offers enormous public health potential benefit," Thompson says.
"If you read the FDA warning letter, the agency clearly invested a tremendous amount of time working with the company trying to guide them through the FDA process. That is extremely rare for FDA to invest that much time in one company."
Thompson says, and its been reported, that the agency sent 23andMe the warning letter only when the company had stopped talking to the agency.
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.
But the company has been talking regularly with the FDA this year. Wojcicki has done more face time at the agency. The two parties, it's believed, are coming to terms and have worked out a template for approving future 23andMe health products.
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. As of June 27, the company's 501(k) application had been received and OK'd for review by the FDA.
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.
