|23andMe CEO Anne Wojcicki|
It was a triumphant Anne Wojcicki who took the stage at this year's TEDMED conference in Palm Springs, CA. She's had a great year--gaining the first FDA clearance for a direct-to-consumer genetic test earlier this year and recently relaunching a broad consumer test that includes more than 60 points of genetic information including disease carrier status, wellness and disease trait.
Her company, 23andMe, was forced by the FDA to pull its consumer genetic test from the market two years ago. Coincidentally, its green flag now for DTC genomic testing has come to fruition just as Theranos, another now rather infamous consumer Dx startup, has recently drawn FDA scrutiny for its own technology that uses tiny amounts of blood to market low-cost tests.
"If you don't take care of yourself, no one else will," was the organizing homily for Wojcicki's talk, which was perfectly calibrated for the proactive, curious and enthusiastic TEDMED audience. She attributes that saying, as well as her urgent interest in an informed healthcare consumer, to her mother, who experienced the death of her own brother at a young age due to poor medical care after he swallowed a bottle of aspirin.
Wojcicki cited a patient survey that showed that most don't know the answers to three core healthcare questions: Who is in charge? How much will it cost? Why am I getting treated?
She built the case for consumer genomic tests as a means of healthcare patient empowerment to have access to their own most basic information. Wojcicki argued that knowing genetic risks early in order to apply preventative care, prevent drug side effects, predict drug responses and implement precision medicine are all potential benefits of enabling consumer direct access to genomic tests.
As evidence, Wojcicki cited a recent 23andMe study that found that about 20% of patients in a BRCA breast cancer study didn't report themselves as Jewish, although a genetic test found that they did have some Ashkenazi Jewish ancestry. The relevant BRCA mutation is common in people with that background.
But despite the supportive, attentive TEDMED audience, Wojcicki steered clear of any of the thornier questions that DTC genomic testing brings up regarding inequities in healthcare access and privacy.
She did suggest that DTC consumer testing raises issues around the usefulness of the traditional one-to-one interaction between patient and doctor. She said that perhaps healthcare could benefit better by integrating consumer education via the Internet and videos, as well as crowdsourcing as potentially preferable for determining a correct diagnosis.
"Healthcare is not about an episodic visit to your doctor. It's about what you do every day," Wojcicki said in closing. "You are in charge of your own health; it is your right and ability to understand. If you don't, your life could depend on it. If you don't take care of yourself no one will."