23andMe sets stage for stronger ties with pharma

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Anne Wojcicki co-founded 23andMe in 2006 with the big idea that informing patients about their genetics would empower them to take control of their health destinies rather than becoming slaves to the healthcare system. With more than 180,000 people who have had 23andMe analyze their genes, Wojcicki has turned the big idea into reality for many of those who have used its personal genomics service.

Less clear is whether the venture-backed company will be able to deliver returns for its investors, but Wojcicki and her team have shown that its research and biopharma ties could benefit patients and its bottom line. 

The Mountain View, CA, company has built an impressive data set of genetic information. This month FierceBiotech profiled Wojcicki, who is CEO of 23andMe, for its annual 10 Top Women in Biotech feature. During the interview, Wojcicki proudly noted that her company has built the world's largest Parkinson's disease community, with genetic records on more than 9,000 people with the neurodegenerative disease. This is one of several disease-focused communities at the company.

Big Pharma has taken a big interest in 23andMe's platform. The rich data could have profound impacts on the development of new treatments and diagnostics, and 23andMe has taken steps to partner with pharma researchers as one of the company's growing lines of business.

"We are doing more partnerships with pharma companies or biotech companies," Wojcicki said. "The role of 23andMe is to have an influence in and a partnership with the biopharma world. And I think, more and more, as the database grows we're able to effectively leverage this database and do partnerships with pharma companies that I think will ultimately really benefit our customers."

Roche's Genentech this year entrusted the personal genomics company with a project involving its blockbuster cancer drug Avastin. Last year, the FDA pulled its support for use of the drug for treating breast cancer for lack of evidence of safety and efficacy. Among other collaborations between the two companies, Genentech has tapped 23andMe to test the genes of women who have taken Avastin for breast cancer and to gather information on those women's experiences on the drug.

The study could find links between women's genetic profiles and certain outcomes of treatment on Avastin. Wojcicki, who spent 10 years as a biopharma and healthcare investor before founding 23andMe, says there have been collaborations with other biopharma companies but she was unable to disclose names.

Beyond supporting Genentech's research goals, 23andMe has raised its game in making discoveries with implications for patient treatment. Wojcicki revealed in May that the company was awarded a patent for its own discovery of a gene that could be protective to a risk factor for developing Parkinson's disease, giving biotech researchers a potential drug target. "If the follow up work we are now doing with the Scripps Research Institute and the Michael J. Fox Foundation looks promising and moves towards drug development," Wojcicki wrote on the company's blog, "the patent will be important for a biotech or pharmaceutical company to pursue drug development."

The news stirred enough of a kerfuffle among patients, some of whom questioned the ethics of profiting from the discovery, for Wojcicki to add an addendum to her May 28 blog post that announced the Parkinson's patent award.

"23andMe will not prevent others from accessing their genetic data or its interpretation specific to our patents," Wojcicki's June 1 addendum stated. "Other entities can present information about the genetic associations covered in our patents without licensing fees. As has always been the case, 23andMe customers can freely apply their raw genetic data to other interpretation tools whenever they wish."

Meantime, the company this year filed for FDA clearance of its personal genomics test, which patients can buy for about $300 and use to learn of their status for more than 200 disease-related and health traits. A company spokeswoman said Wednesday that the company had no updates on the regulatory front.

Wojcicki made clear in her blog post that she's running a business. Though that business has a mission of benefiting patients, the company is clearly seeking to protect a potentially lucrative discovery and is seeking ways to grow. The company has raised three rounds of VC money from Google Ventures, MPM Capital, New Enterprise Associates, Roche Venture Fund and Johnson & Johnson Development Corp. ($JNJ). And according to Wojcicki, 23andMe is not yet profitable but is moving toward putting itself in the black.

Still, 23andMe faces a challenge of balancing its growth as a biopharma partner and player in the research world with maintaining the trust of the people whose genetic profiles helped build the company's valuable data set.

"There was a lot of backlash when they got their Parkinson's … patent," Dan Vorhaus, an attorney specializing in personalized medicine and genetics, told FierceBiotech in an interview. "I think they've got some real potential in terms of the data set that they've been generating, but it's all dependent on having this large and growing and active user base that they can query."

Wojcicki is a true trailblazer in personal genomics, but there's work to be done to prove that her big idea of empowering patients through informing them about their genetics can be profitable. -- Ryan McBride (email | Twitter)