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FDA Cites Long-Term Precedent In Blocking Retail Genetic Screening Plans

This article was originally published in The Gray Sheet

Executive Summary

A particularly public preemptive stance by FDA's in vitro diagnostics oversight office halted Pathway Genomics' plans last week to start selling genetic screening test sample collection kits out of Walgreens stores, but the office's director stresses the move does not signal any changes to its enforcement policy for laboratory-developed tests

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