23andMe Cleared to Provide Health Reports

23andMe Cleared to Provide Health Reports

The FDA allows the DNA testing service to once again include reports on select health conditions in its results.

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Purchasers of the 23andMe Health + Ancestry DNA test now have access to genetic health risk reports for conditions including late-onset Alzheimer’s disease, Parkinson’s disease, Celiac disease and seven others. The United States Food and Drug Administration (FDA) has authorized 23andMe to offer these 10 reports and smoothed the way for similar reports.

This is a big, if incremental, step forward for the company. Its DNA service initially provided ancestry information and genetic risk reports on about 250 conditions. In 2013, the FDA ordered 23andMe to stop providing health-related information to US customers because the company hadn’t proven its tests were “analytically or clinically validated.” After negotiations with the FDA, 23andMe began offering more-limited health-related reports in 2015.

The new reports calculate genetic risk based on the presence (or absence) of specific markers in a person’s DNA. To obtain FDA authorization for them, 23andMe “conducted extensive validation studies for accuracy and user comprehension that met FDA standards,” according to its announcement. The FDA considered evidence tying each condition with the relevant genetic markers and whether 23andMe tests consistently and accurately identify the markers in customers’ DNA.

The FDA also established a streamlined approval process for future genetic health risk reports from 23andMe or other companies. This process will help similar tests “enter the market as quickly as possible and in the least burdensome way,” according to an FDA statement. The new policy applies to genetic risk reports that are informational, not those used for medical diagnoses or to make health treatment decisions. Get a look at the new 23andMe reports.

Learn more about using DNA to understand your personal health in our roundup of tech tools, and discover what genetic genealogy can do in your research with our collection of articles about DNA testing.

A version of this article originally appeared in the September 2017 issue of Family Tree Magazine.

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