23andMe inks Pfizer deal, eyes 2015 resolution of FDA dispute

23andMe CEO Anne Wojcicki

23andMe is on a roll. Days after unveiling a $60 million deal with Genentech, the personal genomics pioneer struck a new database-driven collaboration with Pfizer ($PFE). There is even talk of a possible resolution with the FDA in 2015.

Uncertainty will continue to cloud the regulatory outlook for the foreseeable future, but fortunately for 23andMe these concerns are doing little--if anything--to deter big-name drug developers from partnering. Pfizer gave an early validation of 23andMe's approach to R&D when it partnered on a 10,000-person inflammatory bowel disease study. The drugmaker has now returned to 23andMe for support with genomewide association studies, surveys and clinical trial recruitment.

"The expanding collaboration with 23andMe provides access to a wealth of data. The better we understand the genetic heterogeneity of complex diseases, the faster we may be able to accelerate the pace of development for potential new treatments for the right patient subpopulation," Jose-Carlos Gutierrez-Ramos, head of biotherapeutics R&D at Pfizer, said in a statement. 23andMe will apply its database of 650,000 people who have consented to participate in research to the task.

Like the Genentech deal, 23andMe's collaboration with Pfizer includes a component focused on a specific disease. 23andMe and Pfizer plan to build a 5,000-person lupus community. By genotyping these people and integrating medical records, Pfizer hopes to better understand the genetic causes of lupus. The focus on disease communities sidesteps some questions about the use of 23andMe data in R&D. 23andMe CEO Anne Wojcicki reiterated this week that participation in R&D is voluntary.

The willingness of 23andMe customers to participate in R&D--an opt-in decision--has enabled the company to ink 14 collaborations, including the Genentech and Pfizer deals. Now, the big task is to turn on the data accumulation faucet by resolving the standoff with the FDA. Wojcicki is optimistic. "[We have] quite an active dialogue [with FDA], and I'd hope we'd have some resolution on that this year," Wojcicki told Bloomberg.

- read the press release
- here's Wojcicki's blog post
- check out Bloomberg's article
- and VentureBeat's coverage

Editor's note: This story was updated to clarify participation in 23andMe research is an opt-in choice. Customers can opt-out at any time.