The Food and Drug Administration (FDA) has ordered personalized DNA kit manufacturer 23andMe to stop selling their product due to inadequate scientific backup.
The FDA released a letter to the company demanding they bring sales of their Personal Genome Service (PGS) to a halt, the Associated Press news release reported. The kit claims to identify genetic health risks associated with 250 diseases and conditions.
"Months after you submitted your 510(k)s and more than [five] years after you began marketing, you still had not completed some of the studies and had not even started other studies necessary to support a marketing submission for the PGS. It is now eleven months later, and you have yet to provide FDA with any new information about these tests," the FDA stated in their letter to the company.
The Google-backed 23andMe company found its way around government regulations for years by claiming they were simply providing genetic information to customers, and were not considered to be a medical service. That argument is no longer sound since the company added disease-specific tests to its test kit.
"Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns," Kendra Cassillo, A spokeswoman for 23andMe said in a statement, the Associated Press reported.
The FDA expressed concern that the saliva-based kit could provide women with a false-positive for a high risk of breast or ovarian cancer. This information could cause women to undergo unnecessary preventative surgery or invasive screening processes, Reuters reported. A false negative could also prevent women from seeking important screening tests for the conditions.
The FDA said 23andMe submitted applications for "several of these indications for use" in the summer of 2012.
"However," the FDA said, Reuters reported. "To date your company has failed to address the issues described during previous interactions with the Agency" or provided additional information requested. As a result, the FDA said the applications 'are considered withdrawn.'"
