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Hill scrutinizes genetic testing firms

This article was originally published in The Gray Sheet

Executive Summary

House Energy and Commerce Committee is investigating three firms that market personalized genetic testing directly to consumers following a high-profile announcement and reversal by Pathway Genomics earlier this month on plans to start selling its test collection kits at Walgreens retail outlets. Bipartisan leaders of the committee sent letters May 19 to 1Pathway, 223andMe and 3Navigenics, each of which sell genetic test sampling kits and testing services via the Internet, requesting documentation in support of the accuracy of the testing services, of sufficient staff training, of appropriate procedures for providing results to patients and handling DNA samples, and of compliance with FDA regulations. Walgreens delayed plans to carry Pathway's sampling kits after FDA made a public case that the firm was bucking agency regulations by offering the kits and services without approval (4"The Gray Sheet" May 17, 2010)

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