The Food and Drug Administration (FDA) has told the Google-backed DNA analysis company 23andMe to stop selling its DNA test kits.
23andMe was asked to halt the sale of the kits, its main product, since they are being sold without "marketing clearance or approval," which violates the Federal Food, Drug and Cosmetic Act (FD&C Act).
The Saliva Collection Kit and Personal Genome Service (PGS) from the company lets users known whether they carry a disease, are at risk of an illness and would respond to a drug.
Most of the uses of the product fall into the medical device category and require approval from the FDA, per the agency's letter to California-based 23andMe's co-founder and CEO Ann Wojcicki.
Wojcicki started 23andMe six years ago to aid people in assessing their risk of cancer, heart ailments and other medical conditions.
"FDA is concerned about the public health consequences of inaccurate results from the PGS device," the agency wrote in the letter. "The main purpose of compliance with FDA's regulatory requirements is to ensure that the tests work."
In the letter, the FDA outlined the work it has done with 23andMe since 2009. However, this has been futile. The FDA even noted that it had given the Google-backed company feedback on study protocols, as well as discussed regulatory ways and given statistical advice.
"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," wrote the FDA.
FDA asserts that it has not heard from 23andMe since May this year. Moreover, during this period, the company has gone ahead and initiated new marketing campaigns that include TV spots and are indicative that 23andMe is looking to expand the product's use without acquiring the necessary marketing clearance from FDA.
In 2010, FDA has ruled that services that claim to assess a customer's risk of disease are required to be cleared by regulators if the company is directly selling the products to consumers. Usually, most of the FDA-cleared genetic tests are for a single ailment, whereas 23andMe's kit would be the first to test multiple diseases.
"We recognize that we have not met the FDA's expectations regarding timeline and communication regarding our submission," said Catherine Afarian, a spokeswoman for 23andMe, in an emailed statement. "Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns."
"We stand behind the data that we return to customers - but we recognize that the FDA needs to be convinced of the quality of our data as well," said Wojcicki, who is the estranged wife of Google co-founder Sergey Brin, in a blog post.