23andMe Suspends Access To Health-Related Genetic Reports After FDA Complaint
DNA sequencing company 23andMe has decided to suspend new consumers' access to genetic tests following a complaint from the Food and Drug Administration questioning the accuracy of the service and its effects on self-diagnosis.
DNA testing company 23andMe has decided to suspend new consumers' access to health-related genetic reports following a complaint from the Food and Drug Administration questioning the accuracy of the service and its effects on self-diagnosis.
The service is now also halting testing on any kits purchased after November 22. In a blog post, 23andMe founder Anne Wojcicki explained the situation:
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.
We also want to make clear that we stand behind the data we have generated for customers. Our lab partner adheres to strict quality standards that are part of the Clinical Laboratory Improvement Amendments of 1988 — known as CLIA. These are the same standards used in the majority of other health and disease-related tests. We decided several years ago to comply with CLIA guidelines to be consistent with other types of laboratory testing and to assure customers about the quality of data.
Wojcicki claims that their tests are more than 99.9 percent accurate. In addition, customers who purchased a kit before the company received their warning on the 22nd will be entitled to a full refund. Those who did so prior will still be able to access all of their test results.
This is a stoppage of health testing analysis, not a complete lockdown on the service. According to The Verge, customers who bought a kit after the warning will still receive ancestry information and raw results, but no interpretation of those results.