Genetics company 23andMe has received a public warning letter from the Food and Drug Administration (FDA) for marketing its genetic testing kit without proper clearance and approval.

Regulators asked that 23andMe halt marketing and sales of its Personal Genome Service (PGS) until it receives the requisite regulatory approval. The company has 15 days to provide specific actions to address these issues. At the time of this report, kits were still for sale on the company’s website.

The Google-backed 23andMe claims to have a simple test that is “saving lives.” For just $99 and a sample of your DNA, the company will send its customers a report, replete with information about their health and ancestry. On its website, 23andMe says it will provide “health reports on 254 diseases and conditions.”

The FDA is contending that 23andMe’s method of collecting DNA — its Saliva Collection Kit and PGS — is a medical device under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The device has not obtained clearance, and is therefore misbranded under the law.

The agency says that 23andMe has not “analytically or clinically validated the PGS for its intended uses,” which have diversified and expanded in recent years.

Regulators are concerned that a false positive could result in unnecessary surgery, and false negatives could lead to patients being less aggressive about screening for various health risks. The agency is most concerned that 23andMe is testing various mutations of genes that indicate a woman might have a high risk of getting breast or ovarian cancer. The FDA believes a false positive on that test could cause a woman to undergo a needless mastectomy.

The FDA, a government agency that is responsible for food and patient safety, has “serious concerns” if the results of a 23andMe test are not “adequately understood by patients” or if it returns incorrect test results.

“Companies that receive warning letters have the opportunity to address the violations,” said an FDA spokesperson in an interview with VentureBeat. “If the violations are not addressed to the satisfaction of the FDA, further actions may be warranted, including seizure or civil money penalties.”

To bring clarity to health entrepreneurs, the agency recently released its final guidance on how it intends to regulate the new crop of mobile health applications. Regulators said they would keep a particularly close eye on apps that seek to replace a doctor’s visit or perform clinical tests.

The FDA claims it has repeatedly reached out to 23andMe, but the company has not yet “completed some of the studies and had not even started other studies” necessary to gain regulatory clearance.

“My gut tells me that the company isn’t challenging process but is instead challenging the very regulatory definition of what it is to be a device,” said Lauren Fifield, a health policy expert at Practice Fusion, who works closely with the FDA. “What remains to be seen is whether the company and tech industry can convince the government that safety can be increased, or at least balanced, by innovation rather than set at odds.”

This isn’t the first time that 23andMe has come under fire. Last month, we released our special report on privacy concerns with 23andMe, with consumers sharing their test results on Facebook. The company had recently begun advertising its service on social media sites as well as broadcast television networks.

23andMe’s goal, according to its marketing materials, is to grow to a million customers by the end of the year. The company is compiling the world’s largest “genetic data resource,” its chief executive, Anne Wojcicki, recently said to “address unanswered questions related to the contributions of genes, the environment, and your health.”

A company spokesperson would not respond to repeated requests for additional information. 23andMe referred me to the following statement:

We have received the warning letter from the Food and Drug Administration. 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.

This story is developing. We’ll update you as we learn more. 

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