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Kind of a Big 'Whoops'

Genetic Future's Daniel MacArthur discusses the 23andMe's recent "lab mix-up [that] resulted in as many as 96 customers receiving the wrong data." In his analysis of the 23andMe announcement (accessible only to registered users), MacArthur opines that likely a single 96-well plate was affected, which "resulted in incorrect results being sent to customers, with some alarming consequences" Namely, he says, "one mother posted on the 23andMe community about her distress upon discovering that her son's results were incompatible with the rest of the family." The blogger says that while mistakes happen in nearly every lab, 23andMe's sample switch does not bode well for DTC genetics services. "If the industry is to survive the massive scrutiny currently being pointed in its direction following the Pathway/Walgreens debacle it must avoid any appearance of being amateurish; this type of mistake adds even more fuel to the regulatory fire burning under the industry," MacArthur writes. In its announcement, 23andMe acknowledges the "gravity of this incident," and says that they 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." For example, the company is "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," the statement reads.

The Scan

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