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.
Anne Wojcicki CEO 23andMe

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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