Direct-to-consumer genetic testing company 23andMe will stop sales of health-related tests following a warning letter from the Food and Drug Administration two weeks ago.
“23andMe has been giving consumers access to health information for six years and is committed to finding the right regulatory path for our customers,” CEO and founder Anne Wojcicki wrote in a statement on the company website Thursday. “I am highly disappointed that we have reached this point and will work hard to make sure consumers have direct access to health information in the near future. Our goal is to work cooperatively with the FDA to provide that opportunity.”
The goal of 23andMe is to provide consumers with direct access to their genetic information in an easy and affordable way. A test can be purchased online for $99, and provides reports on 254 different conditions and diseases.
However, the FDA expressed concerns that the company was selling its product as a diagnostic test for health risks. The agency said 23andMe must gain government authorization before continuing to market the product as a medical test.
The company will continue to provide ancestry information and raw data to consumers, but will put the sale of health-related results on hold.
Individuals who purchased genetic testing kits prior to when the FDA letter was sent on Nov. 22 will continue to have access to their full results. Those who purchased them on or after that date will only receive ancestry information and raw data, and will be eligible for a refund.
Wojcicki emphasized that the company stands by their data, noting that the samples are sent to CLIA certified labs — the same standards used for most health-related tests.
“The information 23andMe provides is incredibly accurate,” 23andMe spokeswoman Catherine Afarian told National Journal in early November. “If we tell you you’re a C-C there, you are. From there, the next step is interpretation — what does science know about it?”
This is where the results become less clear.
As National Journal previously reported, there is a significant amount of uncertainty regarding the interpretation side of these test results. The concern is that individuals may make important medical decisions based on results that are constantly changing and that even experts don’t completely understand.
The company will continue to move forward with the FDA’s regulatory review process, and hopes to resume offering health-related information shortly.
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