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Advisory Panel Endorses OraSure In-Home HIV Test

This article was originally published in The Tan Sheet

Executive Summary

An FDA advisory committee endorses OraSure’s OraQuick in-home HIV test in a unanimous vote. If approved, OraQuick would be the first OTC test for HIV that untrained users can perform entirely in the home.

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In Brief

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OraSure Plans To File Over-The-Counter HIV Test Application By Year End

OraSure Technologies says it expects this year to complete a pre-market application for its OraQuick Advance Rapid HIV-1 and -2 over-the-counter saliva test. The product would be the first HIV diagnostic intended for use at home and providing results directly to the user.

CDRH Focusing On New PMA Pathway, Clinical Trials Program In 2014/2015 Priorities

CDRH Director Jeffrey Shuren discussed the device center’s two-year strategic priorities with “The Gray Sheet.” The center plans to rebalance pre-market and post-market data collection, when appropriate, and improve the processes for starting up clinical trials in the U.S.

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