The Google (NASDAQ:GOOG)-backed home genetic testing company 23andMe may be having a second life thanks to government interest in the genetic data collected by a product the FDA said was in violation of marketing regulations.
A two-year $1.4 million grant from the National Institutes of Health will let the company build a Web-based database and “research engine for genetic discovery” from the vast amount of information it has collected from more than 400,000 customers.
In November, the FDA prohibited the company from marketing its $99 genetic testing device as a way to determine an individual's predisposition to serious illnesses like cancer -- a promise that put the company on the map. Now, 23andMe is capitalizing on its large database of genetic information amassed through the sales of that device, and it’s offering a new promise that the data can be used to further medical discoveries.
"23andMe is building a platform to connect researchers and consumers that will enable discoveries to happen faster," Anne Wojcicki, co-founder and CEO of 23andMe, said in a statement Tuesday. While genetic information from 23andMe customers cannot be shared with the general public, customers are asked to give consent to share their genome data with researchers who can access their database for medical research.
The company has already showed the value of its data set. Earlier this week, a paper published in the journal Nature Genetics described how 23andMe contributed data from 4,000 customers with Parkinson’s disease and 62,000 who did not have the illness, which helped identify new genetic risks associated with the degenerative disorder. In 2011, 23andMe contributed data to another study that discovered two other genetic associations with the disease.
"We want to be that last mile of communication and interpretation of genetic data," 23andMe President Andy Page told Fast Company. "As more and more people [interpret genetic data], and we establish more partnerships where we become that interface between institutions that are offering the tests [and individuals], we can build communities around certain disease states." For instance, if 23andMe collects information from thousands of heart disease patients, theoretically it could monetize the data when new treatments develop.
When 23andMe’s testing device launched, it was marketed as a way to see whether an individual was predisposed to serious medical conditions like cancer, heart disease and degenerative disorders. This language -- which included phrases like “the first step in prevention” and “carrier status” -- brought FDA scrutiny: The agency objected to the product being advertised as a “medical device,” a designation that required the FDA’s approval -- which 23andMe didn’t have. Since July 2009, the company has been in negotiations to seek FDA approval but it’s been a bumpy road, and 23andMe hit its most significant roadblock in November 2013 when the agency cited concern over the “public health consequences of inaccurate results” of the at-home DNA test and forced the company to stop marketing it as a diagnostic tool.
For now, users can still purchase the $99 at-home DNA kit, but they will not receive the health reports that formerly accompanied the purchase. Instead, buyers will get an ancestry report and uninterpreted raw genetic data.
“Unless you are really curious to find out that you are a descendant from Europe or Africa, most people already know where they are from, nothing new was learned from this aside from a lighter wallet,” a user identified as Danielle Comolli wrote in a review on Amazon published in February.
Though lauded in some corners for its innovative novelty, 23andMe had its share of skeptics from the outset. The company’s co-founder, Wojcicki, is the wife of Google's Sergey Brin – who revealed having a rare genetic mutation which gives him a 20 to 80 percent chance of developing Parkinson’s disease. The Google connection not only explains the company’s involvement with Parkinson’s research but also strongly suggests a mission to collect and share large data sets.
Naturally, there are privacy concerns at stake. While the company asks permission to share an individual’s genetic information for scientific research, the practice is not considered “research on human subjects,” which means consumers are not protected under the same laws that experimental subjects are in terms of privacy and welfare, Scientific American pointed out.
The same article argued that the FDA was missing the point about 23andMe’s “true function,” and that “consequently the agency has no clue about the real dangers they pose.” The problem was not that 23andMe was marketing a medical device, the article said, it was that that device “is a mechanism meant to be a front end for a massive information-gathering operation against an unwitting public.”
Indeed, Patrick Chung, a 23andMe board member and partner at the venture-capital firm NEA, admitted to Fast Company in a November article that 23andMe always had wider aspirations than selling a hundred-dollar saliva-testing kit.
"The long game here is not to make money selling kits, although the kits are essential to get the base level data," Chung said. "Once you have the data, [the company] does actually become the Google of personalized health care."
This leaves many of the 23andMe participants open to identification -- be it by hackers, corporate takeovers or nefarious individuals who can expose someone based on a snippet of genetic information, Scientific American reports. For instance, a study published in the journal Science in January showed how individual’s surnames could be recovered by cross-referencing a personal genome from genetic genealogy databases.
The company itself is vague on how it stores information. VentureBeat pointed out that while during the signup process you can have your saliva sample destroyed, that doesn’t prevent your genome from being stored in the company’s digital records. If the information is somehow leaked, insurers, employers and even potential mates could discriminate based on this genetic information.
For recent 23andMe customers, the concern lies more in the service they receive rather than the privacy implications involved.
Reviews vary from overall satisfaction in discovering a piece of family history to some calling it an “incest dating site” where participants can connect with distant relatives.
And for some, the FDA infractions aren’t a cause for concern.
“I've been more harmed by doctors not interpreting blood tests correctly in private practice than taking this simple and inexpensive spit test,” a user identified as Jean Young wrote in a review on Amazon. “I wish them the best, I think the founder has good intentions. Science takes time to evolve and they will be considered one of the first companies to bring genome testing to the mass market.”