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Top FDA Officials Warn About Non-Vetted Pharmacogenetic Tests After Latest 23andMe Approval

Executive Summary

A day after 23andMe gained US FDA go-ahead for a DTC genetic test service to inform patients about their ability to metabolize medications, the agency issued a safety communication, paired with a joint statement from device- and drug-center heads, warning consumers against trusting genetic tests that have not been vetted by FDA.

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