23andMe customers can now receive information about genetic risk for diseases including Parkinson’s and celiac.

FDA OKs Marketing of DTC Genetic Health-Risk Tests

23andMe customers can now receive

 information about genetic risk for diseases

 including Parkinson’s and celiac.

By Diana Kwon | April 7, 2017

FLICKR, NOSHA

The US Food and Drug Administration (FDA) has 

granted the personal genomics company 23andMe 

authorization to market direct-to-consumer (DTC) 

tests that provide information about a person’s 

genetic risk for 10 conditions, including late-onset 

Alzheimer’s disease, celiac disease, and hereditary 

thrombophilia. This 

authorization, announced yesterday (April 6), does 

not extend to diagnostic tests associated with 

potentially preventative action, such as those for 

BRCA genes.

The FDA emphasized that while results from these 

tests may help inform customers’ lifestyle choices or 

conversations with medical professionals, the results 

should not be considered a diagnosis or be used to 

inform treatment decisions. The agency also noted 

the risk for false-positive and false-negative findings.

“Consumers can now have direct access to certain 

genetic risk information,” Jeffrey Shuren, director of 

the FDA’s Center for Devices and Radiological Health, 

said in the statement. “But it is important that people

 understand that genetic risk is just one piece of the 

bigger puzzle, it does not mean they will or won’t 

ultimately develop a disease.”  

In 2013, the FDA blocked 23andMe from marketing 

its DTC health-prediction services. However, this ban 

was partially lifted in 2015, when the FDA allowed 

23andMe to market its test for Bloom syndrome, a 

rare genetic disease.

Some experts are not convinced that 23andMe’s 

tests will be beneficial. “I don’t think there’s very 

much consumers can do with [the information they 

get from these tests],” Stanford ethicist Hank Greely

 told Vox.

FDA marketing approval “might not be a bad thing,” 

Greely told Forbes. “I’m not enthusiastic. I’m not 

convinced this will improve Americans’ health or 

make consumers better off. But I’m not convinced 

that it won’t.”

Rudolph Tanzi of Harvard Medical School told STAT 

News that consumers will “for sure” require genetic 

counseling to review test results for Alzheimer’s risk.

Tags

genetics & genomics, genetic testing, FDA, direct-to-consumer and 23andMe