In response to a question about the “best advice” she’d received during her career, Ms. Wojcicki discussed the FDA’s decision to issue a warning letter to the company in 2013. The agency asked the company to stop marketing and selling its Saliva Collection Kit and Personal Genome Service, since neither product had received FDA approval at that point.
“It was a rough time trying to figure out exactly what the path forward would be,” Ms. Wojcicki said. “I received some great advice from a regulatory team that in many ways has been applicable for life. She asked me if I wanted to sell the company quickly and get out, or stay in for the long haul and really fight for our mission.”
“I told her the latter,” she continued. “If so, she said just put your head down, do the work you need to do, and don’t give up. It will take years, but persistence will pay off. And persistence has paid off!”
In April 2017, the FDA approved a set of 23andMe’s home DNA tests, which consumers may use to assess their genetic risk for 10 diseases, including Parkinson’s, Alzheimer’s and rare blood diseases.
“I am obsessed with bringing the consumer voice to healthcare,” Ms. Wojcicki said. “As it stands, healthcare is a $3 trillion industry that is primarily a B2B business. I believe everything in healthcare can change if the consumer has a voice.”
To access Quartz‘s interview, click here.
More articles on data analytics & precision medicine:
Penn State launches big data project to drive population health, personalized medicine research
Researchers use predictive analytics, EHRs to forecast hypertension onset
Cincinnati Children’s Hospital Medical Center launches Maternal and Infant Data Hub
At the Becker's 11th Annual IT + Revenue Cycle Conference: The Future of AI & Digital Health, taking place September 14–17 in Chicago, healthcare executives and digital leaders from across the country will come together to explore how AI, interoperability, cybersecurity, and revenue cycle innovation are transforming care delivery, strengthening financial performance, and driving the next era of digital health. Apply for complimentary registration now.