The letter, sent Friday, said that the company had failed to provide additional evidence showing their product was accurate. The service, accessed by nearly half a million people, tells them if they are at high or low risk of developing particular diseases.
"To date, 23andMe has failed to provide adequate information to support a determination that the PGS is substantially equivalent to a legally marketed predicate for any of the uses for which you are marketing it," the agency wrote in the letter.
23andMe is backed by Google founder Sergey Brin's wife Anne Wojcicki. While 23andMe has been in correspondence with the FDA for approval of its product, the agency has had reservations about the accuracy of the results provided.
Because the product is used in the "diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease," it is considered a medical device subject to FDA approval.
The letter states that the agency is particularly worried about diagnosis of diseases related to BRCA genetic mutations, like breast or ovarian cancer. A false diagnosis of this kind of disease could lead the patient to undertake extensive and invasive treatments, while a failure to diagnose could delay much needed treatment.
Assessment for drug responses, which the product also promises, may lead to patients "to self-manage their treatments through dose changes or even abandon certain therapies depending on the outcome of the assessment."
23andMe released a statement acknowledging the receipt of the FDA letter, without going into further detail.
"We recognize that we have 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."
23andMe now sells its service, which also offers ancestry information, for $99. It is aiming to grow to 1 million customers by early next year as demand for affordable and comprehensive genetic testing continues to grow.