23andMe is an intriguing company with a fascinating history. It has used genetic testing technology to identify genetic markers associated with specific diseases and conditions. Its customers mailed a test tube containing their saliva to the company, which then analyzed their DNA. For $99, they received a report detailing risks for more than 240 health conditions. The idea was so revolutionary that in 2008 Time magazine named it "invention of the year."
The Start Up
She became able to do something about it when she moved to California in 2006 to be with her boyfriend, Google co-founder Sergey Brin. She became convinced that Silicon Valley could help solve our health system's inability to really deal with diseases.
At a TED conference in 2006, she met Linda Avey, an acquaintance of Brin's and a longtime Biotech executive. The two hit it off and ended up pitching the idea of a DNA profiling company to Google, which invested $3.9 million in the start up. Genentech and other Valley firms signed on.
They dubbed the company "23andMe" for the number of pairs of chromosomes in a human cell. Wojcicki believed the widespread availability of the spit test would improve the relationship between health providers and patients -- giving consumers control over their own destinies like never before.
Wojcicki also thought that collecting genetic information from so many people would enable scientists to decipher DNA patterns and thus create cures for countless diseases.
A Fairy Tale Ends
Brin and Wojcicki were married in May 2007 and have a son and daughter. They've been viewed as the Silicon Valley's "golden couple."
Friends nicknamed them "the twins," because they seemed in sync about everything from the future of technology to their unconventional wedding -- a secret ceremony where the bride is said to have worn a white swimming suit and the groom a black one. They swam to a sandbar to exchange their vows.
Their fairy tale ended this year when the news leaked of Brin's affair with a colleague who was working on the Google Glass project with him. Here are Brin's lover, Wojcicki, and Brin -- all sporting the fancy eyewear:
Shortly after the company was set up, Brin volunteered as an alpha tester for the spit test. Wojcicki was shocked to discover he carried the LRRK2 gene associated with Parkinson's disease. She tested Brin's mother and found that she had it, too.
Wojcicki and Brin have contributed more than $150 million to the Michael J. Fox Foundation. Together, 23andMe and the Foundation identified more than 12,000 people with LRRK2 gene -- people who are willing to answer survey after survey about everything, from how much they sleep to environmental hazards near their home. Scientists hope this data may lead to a breakthrough.
Wojcicki heard about another gene she believes may protect against Parkinson's disease and moved to patent it. The company faced widespread criticism when the news came out in May 2012 that the patent had been granted.
Problems with FDA
In 2010, the FDA notified several genetic testing companies, including 23andMe, that their genetic tests are regarded as medical devices and therefore require FDA approval to market them. (FDA approval was not required for genetic-testing companies that work through doctors and genetic counselors.)
23andMe applied for approval and began meeting with the FDA. Last August, the company began running a compelling national commercial in which attractive young people explained that for $99 you could learn "hundreds of things about your health," including whether you "might have an increased risk of heart disease, arthritis, gallstones...." It was the centerpiece of the company's campaign to sign up one million consumers. The commercial's headline was "change what you can, manage what you can't."
On November 22, after not hearing from 23andMe for six months, the FDA ordered the company to stop marketing its Saliva Collection Kit and Personal Genome Service. The company worked out an agreement with the FDA to continue selling the tests, but only providing raw genetic data and ancestry information, not health reports.
Since then, stung by a slowdown in new customer sign-ups, 23andMe has been talking regularly to the FDA, eager to craft a submission that would secure government approval.
Last month, after seven months in the FDA penalty box, 23andMe took the first step toward getting back in the game of providing health reports. It submitted an application for a health report that would provide its customers an assessment of their risk of Bloom syndrome, a rare inherited disorder associated with short stature and various cancers that often cause patients to die in their mid-20s. The FDA agreed to accept the submission, starting a process for a 90-day review period, during which the FDA could come back asking more questions and adding further requirements.
23andMe has a long and winding road ahead of it. Its initial submission was for one report on a rare disease, far less than the 200+ assessments it provided before the warning letter. This first application is likely to take many months... if it gets approved at all.
Approval could also carry restrictions, especially concerning diagnostics about diseases like Alzheimer's or breast cancer that might upset or confuse people. It's possible the FDA might require such tests to go through a doctor or genetic counselor first. That would be a blow to Wojcicki's vision of providing consumers direct control of their genetic information and thus their own healthcare.
Needless to say, the FDA's action has evoked heated comments pro and con. One of the more balanced pieces I saw was a commentary published in New England Journal of Medicine. Here's the concluding paragraph: