Some customers who recently ordered our Personal Genome Service™ have had to wait more than the usual four to six weeks after spitting to get their genetic information. We know that it can be frustrating to wait when you are curious about what your genome holds, so we would like to apologize and offer an explanation for the delay.
Because 23andMe is creating an entirely new kind of business in delivering personal genetic information, the regulatory requirements we face are both complicated and uncertain. Because of the way these requirements are evolving, we recently changed the laboratory where our customers’ saliva samples are processed.
Our new contract laboratory is certified as a “high complexity” laboratory under the federal Clinical Laboratories Improvement Act of 1988 (CLIA). Though CLIA certification and oversight are appropriate for specific health and disease-related testing, we are complying with these guidelines to be consistent with other types of laboratory testing.
This switch does not affect in any way the nature or quality of the information we provide. We are still using the same technology as before. However, the transition from one lab to another has resulted in delays that are temporarily increasing the length of time it takes to process customer samples.
At no time have we experienced any problems with data quality. We are confident, after comparing genome scans from the previous and new laboratories, that they produce consistent information at greater than 99.9 percent accuracy. That means customers who had their samples processed before the switch will not be at a disadvantage now or in the future.
Again, we regret the inconvenience to our new customers. We expect to be able to resume our normal pace of operations within a few weeks. And in the long run, we believe this switch will benefit all of our customers. We’re excited to continue building the 23andMe community!