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Direct Access Diagnostics

This article was originally published in The Gray Sheet

Executive Summary

J&J subsidiary's Confide home HIV testing system should be approved by FDA immediately in order to encourage more people to seek testing, a Washington, D.C.-based conservative think-tank, Coalitions for America, urged at a Dec. 13 press briefing. Calling FDA's inaction on the company's seven-year-old premarket approval application for the device "unconscionable," Coalitions Chairman Paul Wayrich said "the government's own data indicate that the number of Americans who would get testing if the home option were available more than triples." Joined by the Institute for Justice, the Coalitions for America said continued delays in getting the home-use HIV kits to market may result in "a legislative remedy," which "is now very possible given the new political realities in Washington"
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