Having endured a 2013 FDA ban on selling the part of its $99 personal genome service that provided health-related results, 23andMe has come back strong with a new business strategy that involves more than a dozen partnerships with major biopharmaceutical companies.

While 23andMe continues to sell its DNA-laden saliva kits that provide raw genetic data without interpretation along with information on an individual’s ancestry, it no longer can provide health risks, drug response, inherited conditions and traits without explicit regulatory approvals.

Recently the company announced a deal with Genentech, in which 23andMe will se­quence genomes to help find more effective treatments for Parkinson’s disease.

It also announced a new database-driven collaboration with Pfizer looking at many disease areas, including a focus on gain­ing a better understanding of the genetic causes of lupus. That deal follows a partner­ship with Pfizer announced last summer to research potential genetic factors associated with inflammatory bowel disease. Since then, nearly 5,000 patients from 23andMe’s database have enrolled.

A third research agreement with Reset Therapeutics will study circadian clock genes and ultimately improve therapeutic development for diseases related to molecu­lar clocks. Disruption of normal circadian rhythms are associated with diseases of the central nervous system, immune system dysfunction, cancer and cardiovascular and metabolic disorders.

“Our business model really hasn’t changed, as we saw that our consumer busi­ness with the kits was one side—and the brand we are most associated with—and the growth of our database would attract both academic and industry partners,” said Andy Page, 23andMe president. “We always saw the need to expand our staff with a ded­icated regulatory team. We also grew at the executive level with a chief medical officer, a chief communications officer and a chief legal and regulatory officer, and expanded our research portal.”

The three deals are among 14 collabora­tions with biopharmaceutical companies and universities signed last year. They all rely on 23andMe’s most valuable asset: genetic information from its 850,000-customer da­tabase. It has grown steadily since the com­pany’s formation in 2006, when consumers purchased the DNA-infused saliva kits to receive their personal genetic analysis. Page said more than 80% of those custom­ers have consented to donate their data to R&D—a cohort that enables researchers to connect clinical data on how patients feel and how their diseases progress from their genomic side.

“In growing the database, we were able to engage corporate customers in research and we accelerated the pace of discovery in 2015, which validated our R&D model,” said Emily Drabant Conley, director of business development for 23andMe. “We built an infrastructure around the data that includes a research portal that provides access for researchers but also protects patient data privacy.”

For Pfizer, working with 23andMe pro­vides a wealth of data, as it is the first spon­sor able to access the estimated 650,000 people who have consented to participate in research. Under the deal, the companies will collaborate on a number of genome-wide association studies, surveys and clinical trial recruitment projects.

“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, Pfizer’s head of biotherapeutics R&D, said in a statement.

For Genentech, collaboration plans call for accessing the genomic data of 3,000 people from 23andMe’s Parkinson’s disease community and performing whole genome sequencing. From that research, Genentech expects to identify new drugs for Parkinson’s disease, along with evidence for existing therapies in its pipeline.

With plans to divulge some of its other industry partners, 23andMe also is striving to resolve its standoff with the FDA that began in November 2013, when the agency banned it from providing genomic health analysis in its reports—a limitation that has impeded the growth of its consumer kit business. One small recent step forward was the approval of a test limited to the detec­tion of a rare genetic disorder called Bloom syndrome. It is associated with short stature, sun sensitivity and higher cancer risk.

“What is really critical to the FDA is the underlying analytics of our overall platform,” said Page, adding that he cannot be more specific. “The FDA has become incredibly open as we move ahead.”

Ann Wojcicki, 23andMe co-founder and CEO, said in a statement last month that the company and the FDA have “quite an active dialogue, and I’d hope we’d have some resolution on that this year.”

Email comments to Ronald at ronald.rosenberg@centerwatch.com. Follow @RonRCW

This article was reprinted from Volume 19, Issue 04, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »