Originally published June 7.
By Turna Ray
This article has been updated from a previous version to include customer comments, as well as comments from 23andMe about how the company is managing the problem.
23andMe informed its customers last week that the contracted laboratory where saliva samples are analyzed “incorrectly processed” many of them.
“Up to 96 customers may have received and viewed data that was not their own,” 23andMe said in a posting to its community. “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.”
23andMe customers' samples are analyzed by the Laboratory Corporation of America. The company informed customers on June 4, that “the lab is now concurrently conducting an investigation and re-processing the samples of the affected customers.”
Corrected DNA results of affected customers will be posted this week, after "independently verifying the new results," according to the Google-backed direct-to-consumer genomics firm. Meanwhile, LabCorp is expected to complete its investigation in the next few days.
23andMe said it is considering implementing various safeguards to ensure this type of error does not happen again, including removing manual steps at the lab, completely automating the sample analyses, and implementing further data checks before uploading it to customer accounts. “The laboratory will adopt corrective action as warranted based on the findings of the investigation,” 23andMe told customers.
Additionally, 23andMe said it will collect data regarding sex for all new customers prior to laboratory processing as an additional quality check ahead of uploading data.
In response to this announcement, several customers criticized 23andMe's response on the community website. A number of customers affected by the mix-up said the company took more than a day to respond to their queries, although others said the company responded promptly.
Some affected customers realized something was amiss because they received results for the wrong sex or race, but for others it was less obvious.
One customer, after being tipped off by other comments on the site that her report may be inaccurate, reported a wait of more than 20 hours before receiving a response to "frantic" e-mails to customer service. The company informed the customer that the results were not up to certain standards and would be re-analyzed, but allegedly never mentioned that there were actual errors or mistakes made in the laboratory's analysis.
Other customers were satisfied with the firm's response, however. Nora Probasco, who was among those who received incorrect results from the company, told Pharmacogenomics Reporter via e-mail that she received notification from the company within 24 hours.
"I definitely hope nothing like this happens again," she said. "However, I also want it recognized that this company took responsibility early to resolve it."
Another customer, CeCe Moore, told PGx Reporter that the response from 23andMe
"was immediate and satisfying," and noted that the experience serves as an "important step toward self-regulation."
Neither Moore nor Probasco are employed by 23andMe.
Probasco is a member of the International Society of Genetic Genealogists, a voluntary consortium of genetic genealogists, who use DTC genomics tests to "determine their validity for research and develop responsible ways to use them," she said. the ISOGG also maintains a mailing list to keep its members informed about goings on in the DTC genomics community, and "act as an informal watchdog to self-regulate this industry."
Moore is also a member of ISOGG and participated in the beta testing for both 23andme's Relative Finder and Family Tree DNA's Family Finder autosomal testing products.
23andMe told its customers this week that the batch of mismatched records loaded on June 1 was due to "human error" and the "incorrect placement of a single 96-well plate used in processing samples.
"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," 23andMe added.
The error occurs in the wake of a several high-profile setbacks for the DTC genomics industry, which had operated essentially free of formal regulation from the US Food and Drug Administration until Pathway Genomics announced its plans to sell saliva collection kits at Walgreens and CVS stores last month. Following that announcement, the FDA sent a warning letter to Pathway and the US Congress opened up an investigation into the marketing practices of three DTC genomics firms, including 23andMe (PGx Reporter 05/26/10).