A leading personal genomics company, 23andMe, says some of its customers received the wrong test results recently because samples were incorrectly processed. Up to 96 customers were affected by the mix-up. According to the blog Genetic Future, which reported on the mix-up Monday, some customers were upset about the test results before learning that they were given the wrong information. One woman suspected her baby might have been switched in the hospital at birth.
The company, based in Mountain View, Calif., has since notified all of the customers affected and posted an announcement on its website that is accessible to customers who have accounts with the company.
This statement was released to the Los Angeles Times on Tuesday:
"We recently determined that a number of new 23andMe customer samples were incorrectly processed by our contracted lab. We want to clarify what happened with the sample errors, how it happened and what we're doing to prevent it from happening again. Providing each and every one of our customers with accurate data is 23andMe's number one priority, and we fully realize the gravity of this incident.
Up to 96 customers may have received and viewed data that was not their own. Upon learning of the mix-ups, we immediately identified all customers potentially affected, notified them of the problem and removed the data from their accounts. The lab is now concurrently conducting an investigation and re-processing the samples of the affected customers and their accurate results will be posted early next week. We expect the investigation will be complete over the next several days and we will provide further details when we have them.
We are currently putting additional procedures in place that will add an extra layer of safeguards to help assure that similar incidents do not occur in the future. We are deliberating on a process that would include removing manual steps at the lab, completely automating the sample analyses, and implementing further checks of the data before it gets loaded into customer accounts. Please be assured that our testing laboratory's processes comply with strict professional, regulatory, and corporate quality assurance standards for ensuring that all laboratory test results are accurate. The laboratory will adopt corrective action as warranted based on the findings of the investigation.
The science behind 23andMe's personal genetics service remains proven and sound. We recognize that this is a very serious issue and your trust is of the utmost importance. We hope that this helps clarify what has happened and what we are doing to prevent these problems in the future. Please contact me at firstname.lastname@example.org if you have any further questions. We appreciate your comments and feedback."
Although lab mistakes are certainly not uncommon, the experience is a reminder that the field of personal gene testing is new and untested. Genetics experts are not sold on the value of personal gene testing, although medicine is moving swiftly toward a personalized approach and gene testing will, someday, be routine. Labs need to redouble their efforts to minimize potentially devastating mistakes.
[Updated at 1:29 p.m.: This statement was released by 23andMe:
We recently determined that a number of new 23andMe customer samples were incorrectly processed by our contracted lab. We want to clarify what happened with the sample errors, how it happened and what we’re doing to prevent it from happening again. Providing each and every one of our customers with accurate data is 23andMe’s number one priority, and we fully realize the gravity of this incident.
After a full investigation from our contracted laboratory and independent confirmation by 23andMe, we have found that the processing mistake was caused by human error and the incorrect placement of a single 96-well plate used in processing samples.
We are uploading the correct data to impacted customers today, after again independently verifying the new results.
Both our contracted laboratory and 23andMe are adding new procedures to prevent this from happening again. Our contracted laboratory has adjusted the mounting process for these 96-well plates and this new adjustment physically prevents any incorrect manual placement of the plates used at this step of processing. As an additional safeguard, 23andMe will collect data regarding sex for all new customers prior to laboratory processing so an additional quality check can be conducted prior to uploading data.
We are committed to continually improving the quality of our processes. We hope this clarifies what has happened and how we intend to prevent this from happening in the future.]
-- Shari RoanPhoto: A scanning probe microscopic image of human chromosomes. Credit: Reuters