Anne Wojcicki, CEO, 23andMeBio and Contact Info
Listen (5:39) What was your personal reaction to the FDA letter?
Listen (5:34) What is the appropriate level of regulation?
Listen (3:30) Results roulette?
Listen (1:06) What is the path forward with the FDA?
Listen (4:17) How do you go about deciding next steps?
Listen (3:48) Audience: What about international options?
Anne Wojcicki is a fighter. Seen by many in our industry as a leader in delivering genomics to the masses, she now has a more complicated job as CEO of 23andMe.
On November 22 of last year, the FDA sent a letter to Anne and her team in Mountain View telling them to stop marketing their popular genetic testing service. It's a day, Anne says, she'll remember well.
In one of the few interviews she has given since the letter, Anne shares her reaction to it.
"There was a lot of shock. And I think it took a while to settle in to really understand what the implications of the letter were," she says at the top of the interview.
Though some see her as standing strong for the right of the average person to see their genomic profile, yet others in the industry feel Anne and her company are undermining the potential of personalized medicine by delivering an inferior product. Today we ask Anne just what she thinks is the appropriate level of regulation and what is her response to those who say that the 23andMe test is merely genetic "results roulette."
Confirming that the company is working diligently to comply with the requests of the FDA, Anne says she leans on a team that has become used to a "whiplash culture." And while she admits that the company could do a better job of labeling the product, she nevertheless asserts that the "current regulatory process was not ready for us." She's of the opinion that the company can again offer the health related testing.
Today's show reveals a CEO who remains undeterred in her mission while acknowledging a more complex way forward.
"This is not the simple path. It's a fight. And I'm really honored to be part of that fight and driving a change. But I have more headaches than I used to," she says at the conclusion.
Podcast brought to you by: Myraqa Clinical Research: The CRO for Point of Care and PMA Diagnostics.