No Silicon Valley company better embodies the promise and the pitfalls of working in health care than DNA testing firm 23andMe. Launched in 2006 to a flurry of media coverage, the Mountain View, California-based company seemed to have every strategic advantage: millions in startup cash, celebrity endorsements, and a chief executive married to one of the co-founders of Google.
23andMe CEO Anne Wojcicki laid out a bold plan to make genetic testing affordable to the general public, while simultaneously building a massive archive of DNA results for use in medical research. More than 700,000 people have used the company’s test kit, a small plastic tube that customers fill with spit and return to the company for processing.
But last November, the Food and Drug Administration ordered the company to stop marketing its personalized health reports, which purported to tell customers if they were genetically predisposed to more than 250 diseases and medical conditions. Now, 23andMe is working to win FDA clearance for its health tests one at a time, a process that will take years.
Wojcicki spoke to The Associated Press about operating under FDA oversight and the future of her company:
COST OF AN FDA WARNING
One of 23andMe’s highest priorities is to amass a database of 1 million customers’ genetic profiles for use in medical research. With that goal in mind, 23andMe ramped up promotion and dropped the price of its saliva-based test kit to $99 from $299 in 2012. But last year’s FDA warning letter put a damper on that effort. Wojcicki says 23andMe sales have fallen 50 percent since November.
23andMe continues to sell genetic ancestral information and raw, unprocessed DNA data.
RISING TO THE CHALLENGE OF REGULATION
In the aftermath of the FDA letter, 23andMe has brought in four new executives with backgrounds in the health sector.
“This has actually been a really good experience for 23andMe because it’s taking us up a level,” Wojcicki says. “And if we can define this and if the FDA can set out the structure and the path forward, then they are going to enable an incredible amount of innovation.”
SHYING AWAY FROM HEALTH CARE?
In recent months, several leading technology executives have bemoaned the difficulties of navigating government health regulations. Wojcicki says Silicon Valley’s reluctance to back health care ventures is a real issue.
“When I go to some of the big health care entrepreneur conferences you see that there is definitely apprehension about the regulatory landscape in health and how aggressive you can actually be. The fact that there’s potentially always something lurking makes startups nervous.
Filed Under: Industry regulations + certifications