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Consumer genomics company snafu

Due to errors in the lab, as many as 96 customers of consumer genomics company 23andMe “may have received and viewed data that was not their own”, the company informed customers in an announcement on its website (password protected) last Friday.

The announcement says that as soon as the company became aware of the problem, “we immediately identified all customers potentially affected, notified them of the problem and removed the data from their accounts”.

“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,” the statement goes on to say. “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.”

Some of the comments posted to the announcement – a few of which were written by customers affected by the mistake — praise the company’s transparency, while others suggest the company failed to respond to the situation in a timely fashion.

Daniel MacArthur at the blog Genetic Future, who first reported the mix-up this morning, points out that while mistakes can happen anywhere, the industry needs to be particularly careful to maintain its integrity and “avoid any appearance of being amateurish”.

In this case, the damage was relatively minor and quickly rectified, says Sharon Terry, president and CEO of the Genetic Alliance, a non-profit genetics advocacy group based in Washington DC. But she believes the area of genetic testing overall requires “multiple levels of oversight and assurance”, pointing to a recent case in which a genetic test for breast cancer made by a company called Mammaprint had over-reported patients’ metastasis risk by 15% for about 6 months.

In addition to other measures, “there have to be transparent registries, like the Genetic Testing Registry at NIH, and I believe it and other mechanisms should be mandatory to reduce the chaos in the system”, she writes in an email to Nature.

MacArthur also notes that it’s not just regulators who need to be vigilant for errors, but customers themselves, who should be engaging with the information such companies provide rather than passively receiving it. As he points out in his post, “…it is noteworthy that in this case the sample problems seem to have been detected by customers rather than the company”.


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