23andMe Responds to FDA, Halts Health Analysis of Genetic Results - For Now

Genetic test maker 23andMe issued a statement Thursday announcing its decision to stop offering its signature service while the company goes forward with the Food and Drug Administration's (FDA) review processes surrounding it.

The FDA issued a warning letter to 23andMe in November accusing the Google-backed company of failing to obtain the needed approval to market its Saliva Collection Kit and Personal Genome Service (PGS) as a medical device.

"Some of the uses for which PGS is intended are particularly concerning, such as assessments for BRCA-related genetic risk and drug responses ... because of the potential health consequences that could result from false positive or false negative assessments for high-risk indications such as these," officials wrote, citing potential fallout as including unnecessary chemotherapy and surgery, among other things.

In a blog post published four days later, 23andMe Chief Executive Anne Wojcicki defended the product, stating: "We have worked extensively with our lab partner to make sure that the results we return are accurate."

Wojcicki continued: "We stand behind the data that we return to customers - but we recognize that the FDA needs to be convinced of the quality of our data as well."

 Wojcicki took to the blog once again Dec. 5, announcing the company will no longer offer "access to health-related results," but instead provide "ancestry-related genetic information and their raw data," with the possibility of an analysis in the future, pending FDA authorization.

Meanwhile, Wojcicki said the company will continue with its ongoing research, including a current project on Parkinson's disease.

"I am highly disappointed that we have reached this point and will work hard to make sure consumers have direct access to health information in the near future," she wrote. "Our goal is to work cooperatively with the FDA to provide that opportunity."