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


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.

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Posts: 8

December 6, 2017

Both the government and the science industry are woefully unprepared for the potential and administrative uses of genetic information.  First, the fact is that the results can have limited predictive value, with no guarantee of actionable information, and a misconstrued perception of probabilistic risk can pall the image of an extremely valuable program. Secondly, to exacerbate the situation with little protection regarding discrimination can only confirm the inability of the current administration and the scientific community to protect the public.

It appears that the FDA will permit use and distribution of genetic predictive risk with good intent to change lifestyle choices. But it would behoove them to remember that as a non-scientist colleague, the public is rife for misinterpretations and mistrust.

Therefore, to initiate a sense of trust for the public, expansion and enforcement of GINA to include all forms of insurance. Remember that currently it does not cover disability, long term care  or life insurance.  GINA, the Genetic Information Nondiscrimination Act, H.R. 493 states:

“Allows a group health plan to request, but not require, a participant or beneficiary to undergo a genetic test for research purposes if certain requirements are met, including: (1) the plan clearly indicates that compliance is voluntary and that noncompliance will have no effect on enrollment status or premium or contribution amounts; (2) no genetic information collected or acquired is used for underwriting purposes; and (3) the plan notifies the Secretary of Health and Human Services that it is conducting activities pursuant to this exception and includes a description of the activities.”

Change is inevitable. Forethought  is necessary.



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