In a setback for genetic testing company 23andMe, the Food and Drug Administration (FDA) has ordered the company to stop marketing its personal genome service (PGS) to consumers because it failed to respond adequately to FDA’s questions about the product. In a Nov. 22 warning letter sent to CEO Anne Wojcicki, FDA said the company must immediately discontinue marketing the PGS until it receives FDA marketing authorization for the service, which the FDA considers a class III device. 23andMe, based in Mountain View, Calif., in 2012 submitted 510(k) premarket submissions to FDA seeking approval to sell the service. But in the Nov. 22 letter, FDA says to date, the company has failed to address the issues described during previous interactions with the agency to provide additional information requested. The 23andMe Web site says its personal genome service provides health reports on 254 diseases and conditions, including categories for health risks, carrier status, and drug response. According to Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health, the FDA has been diligently working to help 23andMe comply with regulatory requirements regarding safety and effectiveness and obtain marketing authorization for the PGS. Gutierrez says that in 14 face-to-face […]
In a setback for genetic testing company 23andMe, the Food and Drug Administration (FDA) has ordered the company to stop marketing its personal genome service (PGS) to consumers because it failed to respond adequately to FDA’s questions about the product.
In a Nov. 22 warning letter sent to CEO Anne Wojcicki, FDA said the company must immediately discontinue marketing the PGS until it receives FDA marketing authorization for the service, which the FDA considers a class III device.
23andMe, based in Mountain View, Calif., in 2012 submitted 510(k) premarket submissions to FDA seeking approval to sell the service. But in the Nov. 22 letter, FDA says to date, the company has failed to address the issues described during previous interactions with the agency to provide additional information requested.
The 23andMe Web site says its personal genome service provides health reports on 254 diseases and conditions, including categories for health risks, carrier status, and drug response.
According to Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health, the FDA has been diligently working to help 23andMe comply with regulatory requirements regarding safety and effectiveness and obtain marketing authorization for the PGS.
Gutierrez says that in 14 face-to-face and teleconference meetings, hundreds of e-mail exchanges, and dozens of written communications, FDA has provided the company with specific feedback on study protocols and clinical and analytical validation requirements, discussed potential classifications and regulatory pathways, provided statistical advice, and discussed potential risk mitigation strategies.
“However, even after these many interactions with 23andMe, we still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses, which have expanded from the uses that the firm identified in its submissions,” writes Gutierrez.
In a statement posted on the 23andMe blog, the company acknowledges that it has “not met the FDA’s expectations regarding timeline and communication regarding our submission. Our relationship with the FDA is extremely important to us, and we are committed to fully engaging with them to address their concerns.”
Takeaway: Genetic testing company 23andMe must halt marketing its personal genome service after failing to receive necessary FDA approval.
