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Predicting New Regulatory Requirements? There's a Game We Wouldn't Want to Play

Over at 23andMe's corporate blog The Spittoon, founders Linda Avey and Anne Wojcicki address the recent delays customers have experienced in getting results. What's more interesting than the slowdown is the reason for it: while consumer genomics companies are not yet regulated, 23andMe has opted to move its sample processing operation to a high-complexity, CLIA-certified lab. "Though CLIA certification and oversight are appropriate for specific health and disease-related testing, we are complying with these guidelines to be consistent with other types of laboratory testing," Wojcicki writes in the post.

At his Genetic Future blog, Daniel MacArthur wonders why 23andMe switched, when CLIA certification isn't required. "I don't know enough about the regulatory environment in the US to guess at whether this move is simply in order to stay ahead of the shifting demands of regulatory agencies," he writes, "or whether it heralds a move towards a more clinical focus (something the company has explicitly steered away from so far)."


The Scan

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Limited Journal Editor Diversity

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How Much of a Threat?

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