The Food and Drug Administration, or FDA, issued a stern warning to 23andMe, Inc., asking the company to stop selling its DNA test kits, because the company has not yet received its regulatory clearance.
The FDA, in its warning letter dated Nov. 22 and released on Monday, accused the Mountain View, Calif.-based company of selling a product that has not yet proved to be reliable and thus could mislead people about their health conditions. 23andMe, co-founded by CEO Anne Wojcicki, the recently-separated wife of Google co-founder, Sergey Brin, is currently selling a $99 genetic-testing kit that claims to detect more than 240 genetic health conditions and traits to help people understand and prepare against genetic health risks such as breast cancer and heart disease.
“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,” the FDA said in its warning letter.
The agency also warned that most of the company’s claims made on the latter's website regarding the uses of the testing kit have not yet been proved, and slammed the DNA kit-maker for flouting rules and missing deadlines for regulatory clearances.
“Months after you submitted your 510(k)s and more than 5 years after you began marketing, you still had not completed some of the studies and had not even started other studies necessary to support a marketing submission for the PGS(Personal Genome Service),” the FDA’s letter said, adding that the regulator had given detailed and specific feedback and instructions to the company during its interactions, which included “more than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications."
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The FDA letter also accused the firm of marketing the testing kit without taking into consideration the regulator's concerns about the product.
“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.”
23andMe, which derives its name from the 23 chromosome pairs in the human body, in a statement released on Monday, said: "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."
The firm, which has reportedly sold more than 450,000 kits so far, has raised more than $100 million from backers including Google, Google Ventures, MPM Capital and Brin himself.