By Bio-IT World Staff
November 25, 2013
| The Food and Drug Administration issued a warning letter
to 23andMe CEO Anne Wojcicki on Friday, saying the company was selling its spit kits and Personal Genome Service without marketing clearance or approval in violation of the Federal Food, Drug and Cosmetic Act (the FD&C Act).
The direct-to-consumer personalized genomics test is “intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease,” FDA contends, citing language on the 23andMe website heralding the service as the “first step in prevention”.
FDA specifically highlighted concerns about 23andMe’s assessment for BRCA-related genetic risk and drug responses. “For instance,” FDA wrote, “if the BRCA-related risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions, while a false negative could result in a failure to recognize an actual risk that may exist.”
These are not new criticisms. The BRCA concerns, in particular, have been raised by many including Ellen Matloff, Director of the Cancer Genetic Counseling Center at Yale Cancer Center, at the Consumer Genetics Conference in September
The FDA’s letter exudes frustration, pointing out issues that 23andMe had “failed to address… during previous interactions with the Agency,” saying further: “Since July of 2009, we have been diligently working to help you comply with regulatory requirements… 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.”
The letter states that FDA has not received any correspondence from 23andMe since May. That month, speaking at the Big Data in Biomedicine conference
at Stanford University, Wojcicki announced that the company had dropped the price of genotyping to $99 in hopes of getting one million customers by the end of the year and enable “really truly disruptive” research. In August, the company launched a television marketing campaign
“We have become aware that you have initiated new marketing campaigns, including television commercials that, together with an increasing list of indications, show that you plan to expand the PGS’s uses and consumer base without obtaining marketing authorization from FDA,” the FDA’s letter said.
The regulatory body’s directive is clear: “23andMe must immediately discontinue marketing the PGS until such time as it receives FDA marketing authorization for the device.”
At the time of writing, kits were still for sale on the 23andMe site.