Science - August 12, 2014 4:36PM
23andMe, the DNA testing company, was told last year it couldn't market its kit as a health service. It has, however, partnered with drug maker Pfizer to study inflammatory bowel disease using its backlog of genetic information.
In July the National Institutes of Health awarded 23andMe a two-year $1.4 million grant to build a research engine for genetic discovery. The same month 23andMe contributed data from more than 66,000 customers to research that identified new locations of specific genes that are associated with Parkinson's.
"The long game here is not to make money selling kits, although the kits are essential to get the base level data. Once you have the data, [the company] does actually become the Google of personalized health care." Patrick Chung, 23andMe board member
23andMe has also partnered with biotech company Genentech to study metastatic breast cancer and drugmaker Janssen Pharmaceuticals to study rheumatoid arthritis.
"… we have suspended our health-related genetic tests to comply with the [FDA's] directive to discontinue new consumer access during our regulatory review process. We are continuing to provide you with both ancestry-related genetic tests and raw genetic data, without 23andMe's interpretation." 23andMe statement
23andMe announced Dec. 5 that it would stop selling its "health-related genetic tests." The company says, however, that it will continue to provide services to customers that purchased the service prior to Nov. 22, when the FDA sent the company a letter saying 23andMe was violating federal rules.
"The Food and Drug Administration is sending you this letter because you are marketing the 23andMe Saliva Collection Kit and Personal Genome Service without marketing clearance or approval in violation of the Federal Food, Drug, and Cosmetic Act." Alberto Gutierrez, Food and Drug Administration
In a Nov. 22 letter to the company, the FDA said it held 14 face-to-face meetings, video conferences and "hundreds of email exchanges" with 23andMe to try to resolve issues. The FDA says there are still outstanding issues to address regarding false positives and false negatives.