FDA clears way for sales of 23andMe genomic tests direct to consumers

Women In Health IT

FDA clears way for sales of 23andMe genomic tests direct to consumers

This approval is expected to open the floodgates for more direct-to-consumer tests for disease risks.

April 23, 2017

23andMe CEO and Co-Founder Anne Wojcicki recently experienced a reversal of fortune when the FDA changed an earlier decision that prevented her from marketing 23andMe’s Personal Genome Service Genetic Health Risk tests straight to consumers.

Wojcicki co-founded Mountain View, Calif.-based 23andMe with Linda Avey and Paul Cusenza in 2006. Both of Wojcicki’s co-founders later left the company.

In 2013, Fast Company named Wojcicki "The Most Daring CEO.”

The green light from the FDA is expected to open the floodgates for more direct-to-consumer tests for disease risks, and it could pave the way for other companies to enter the market.

Read about the Wojcicki and the FDA reversal here.

Twitter: @Bernie_HITN
Email the writer: bernie.monegain@himssmedia.com

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Clinical, Government & Policy, Population Health, Precision Medicine, Women In Health IT

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