23andMe acknowledged publicly today that as many as 96 customers received the wrong DNA tests after a mix-up involving its testing lab, which extracts and processes DNA from saliva samples that customers send in.
News of the mishap started to leak after 23andMe admitted the mistake last week in a note to its customers on a password-protected Web site. According to one blog, Genetic Future, the problems seem to have been detected first by the customers, who thought their results were too strange to believe.
A spokesman for 23andMe wouldn’t provide details on what happened or say whether any customers used the bad information to make medical decisions. 23andMe does tell customers on its Web site that it can’t diagnose diseases or predict whether customers will get diseases because it doesn’t sequence the entire genome — also, genes by themselves can’t cause a disease
This switch will no doubt add to the negative attention the personal genomics industry has received lately from the government and the media. Along with two of its competitors — Pathway Genomics and Navigenics — 23andMe is being investigated by the House Committee on Energy and Commerce, which asked the companies to send information on their testing services by last Friday.
That investigation started last month after the FDA questioned Pathway Genomics’ plans to sell its saliva collection kit, which the FDA says is a medical device, through Walgreen’s. Walgreens subsequently backed out of the deal.
We do need to get this industry right. It may sell the equivalent of toys now — check NPR’s funny story today about a family that had two DNA tests run on its mysteriously mixed-breed dog, with surprisingly mixed results — but as Smart Planet pointed out this week, personal genetic tests won’t be toys much longer.
That’s because the price of sequencing a gene keeps dropping — within two years it should be as low as $30.
Here’s 23andMe’s latest explanation of what happened:
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.