FDA orders sales of company’s genetic tests halted


The Food & Drug Administration, citing concerns about the expanding scope of genetic tests and their marketing, has told the genomic testing company 23andMe it must stop marketing its in-home saliva collection kit and related genomic analysis service to consumers.

In a letter sent Friday to 23andMe, Alberto Gutierrez, director of the FDA’s office of in vitro diagnostics and radiological health, asserted that 23andMe’s spit test is a medical device that is used in the diagnosis of diseases or other conditions, or in curing, treating, mitigating or preventing disease.

But despite having applied in 2012 for FDA clearance of its test, the firm has failed to satisfy repeated FDA requests for data to support its submission, Gutierrez wrote in a letter sent Friday to 23andMe.


“We still do not have any assurance that the firm has analytically or clinically validated the [Personal Genome Service] for its intended uses, which have expanded from the uses that the firm identified in its submissions” to the FDA, Gutierrez wrote.

23andMe offers genomic analysis for some 254 health-related conditions and has said it aims to reach a million customers eager to learn about everything from ancestry to genetic variations that would blunt the effectiveness of certain drugs. In recent months, it has stepped up its marketing of genomic analysis services, launching an advertising campaign on television.

The FDA has expressed particular concern over the company’s marketing of services to detect the BRCA gene mutation, which confers a greatly heightened risk for ovarian and breast cancers, as well as tests of gene variants that affect the metabolism of certain drugs, such as the blood-thinner warfarin and the anti-platelet drug clopidogrel. False positives or false negatives on tests of such conditions could have consequences for the health of customers, the FDA has said.

The FDA’s concerns echo those of genetic counselors, who have warned for years that unleashing commercial genomic tests on unwary consumers can lead to unwarranted anxiety as well as complacency, and poor health choices as a result.

“It’s a situation of not knowing what you don’t know,” says Rebecca Nagy, current president of National Society of Genetic Counselors. “You’re mixing together information on things that could be life-altering with things that could be fun to talk about around the dinner table. Consumers are just not aware of some the limitations” of these tests, “as well as some of the risks,” said Nagy.

Nagy said that genetic findings that suggest a propensity to certain complex diseases, such as heart disease and diabetes, can be the most fraught with possibilities for misunderstanding and incomplete answers.


“They’re really testing the tip of the iceberg: If you get a normal result on one of these tests, it doesn’t mean your risk is normal,” said Nagy. “In the clinic, we find people come with their test results and say they don’t need to worry” about conditions such as heart disease, when a family history or a look at other risk factors would suggest otherwise, said Nagy. “They may get a false sense of reassurance about a test result when, in fact, they need to take specific steps to lower their risk,” she added.

In a statement issued Monday, the Mountain View, Calif.-based company suggested it would comply with the FDA’s demand for more information.

“We recognize that we have not met the FDA’s expectations regarding timeline and communication regarding our submission,” the 23andMe statement said. Our relationship with the FDA is extremely important to us, and we are committed to fully engaging with them to address their concerns.”