MOUNTAIN VIEW, CA: 23andMe is working with AOR WCG after the Food and Drug Administration ordered it to stop sales of its genetic testing kits, which had not received proper clearance and approval.
In a warning letter, FDA regulators said the company is breaching federal law by stating that its products identify health risks for more than 250 diseases and conditions. Such claims are only permitted by FDA-cleared medical tests, according to the federal agency.
WCG is the PR AOR for 23andMe. The agency declined to comment on its specific duties for the genetics company in this case. 23andMe would not comment on its internal or external communications strategy in reaction to the FDA's caution.
“We recognize that we have not met the FDA's expectations regarding timeline and communication regarding our submission,” said 23andMe spokesperson Kendra Cassillo, in a statement emailed to PRWeek. “Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns.”
Regulators are concerned that false results from the saliva-based test kit, which 23andMe claims is a “first step in prevention” against diabetes, heart disease, and breast cancer, could cause patients to receive inadequate or inappropriate medical care.
In July and September 2012, 23andMe submitted FDA applications for two types of medical device reviews. The company failed to address “the issues described during previous interactions,” which included more than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications, according to the FDA's letter.