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 hadnt 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 persons 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.