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Few Years Later

The US Food and Drug Administration has given 23andMe authorization to market its direct-to-consumer health risk tests, as GenomeWeb has reported. The company will now offer 10 health risk tests, including ones for Parkinson's disease, late-onset Alzheimer's disease, and celiac disease, it adds.

"It's a watershed moment for us and the FDA," Kathy Hibbs, chief legal and regulatory officer at 23andMe tells Nature News. "We are all really tired and really happy."

In 2013, the agency ordered 23andMe to stop selling its genetic health risk tests, saying it was "concerned about the public health consequences of inaccurate results." The firm complied and limited its offerings to ancestry, trait, and other non-medical tests. In 2015, it received clearance from the agency to offer a Bloom syndrome carrier test directly to consumers and, later in the year, began to offer a wider range of carrier tests.

To garner this most recent authorization, GenomeWeb notes that 23andMe had to show that there were studies linking the genes they analyzed to disease risk, demonstrate that their test could detect variants linked to the conditions, and show that 90 percent of customers understood their test results. It adds that this authorization does not include diagnostic genetic testing, such as for BRCA1 or BRCA2 variants, that could guide treatment decisions.

Though, 23andMe now can offer DTC testing that will tell people whether they are at higher genetic risk of developing disease, FDA says consumers shouldn't take their results to mean they definitely will or will not develop a certain disease. As the Verge adds, there are also likely unknown genetic factors as well as environmental and other influences at play.

The agency says the tests "should not be used for diagnosis or to inform treatment decisions," but may "help make decisions about lifestyle choices or … inform discussions with a healthcare professional," as Technology Review points out.