On November 25th, Joel Hruska authored an article in ExtremeTech entitled FDA suspicious of 23andMe genome-testing kit, demands evaluation, reporting that as of November 22 the FDA has brought 23andMe activities to a halt. 23andMe is now prohibited from selling any of its DNA analysis kits until it receives FDA authorization for the device.

The FDA took action to block 23andMe after years of allowing the product to be sold because, according to a letter, 23andMe has increased the number of claims it makes for its product regarding the total number of genetic factors it can analyze and the conditions it detects — but it has failed to submit proof of the efficacy of its detection methods or the error rate.

The article indicates that in 2011, 23andMe claimed to test carrier status for 24 conditions, 20 drug responses, 113 disease risks, and 51 specific traits. Today, 23andMe claims to test carrier status on 53 conditions, 25 drug responses, 122 disease risks, and 60 specific traits. That’s an increase of 25%.

Apparently, the FDA letter gives 23andMe 15 days to either fix these problems or submit a timetable for fixing them. If the letter is accurate, and the company has failed to submit data demonstrating that it actually tests for what it tests for, that’s genuinely problematic. It’s critically important that such tests be accurate.

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Updated: August 16, 2017