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Relevant fine print from FDA decision: i A prominent and conspicuous limiting statement that the test provides only a preliminary test res

Relevant fine print from FDA decision: i A prominent and conspicuous limiting statement that the test provides only a preliminary test result that needs to be confirmed using an independent pharmacogenetic test without such a limitation prior to making any medical decisions. Alternatively, appropriate design verification and validation activities, including the generation of robust analytical data demonstrating appropriate analytical accuracy and reliability of test results for each genetic variant included in the test report, must be performed that demonstrate that the test can be used to make well-informed clinical decisions. In other words, any test results (at least related to drug metabolism) require... confirmation with another test?

mertd 8y ago
They are just saying don't take medical action based on our results and hold us liable.
skwb 8y ago
Two things: 1. 23 and Me has a history of overhyping their science when it comes to medical claims. FDA back in 2013 threatened regulatory action due to their wafarin (blood thinner) metabolism claim. https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm376296.htm https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/... 2. FDA regulates marketing and claims that you can make for products including drugs/devices (but that whole regulatory framework is a story for another day). You need to have certain regulatory approval for formalized medical testing/reimbursement (remember that 23 and Me is targeting consumers, not traditional patients).