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OraSure pushes HIV test

This article was originally published in The Tan Sheet

Executive Summary

OraSure Technologies continues to seek FDA approval of its OraQuick HIV OTC over-the-counter test based on feedback from a closed-door FDA advisory panel session, the firm says Nov. 18. During a Nov. 17 meeting of FDA's Blood Products Advisory Committee to discuss over-the-counter, home-use HIV test kits, the panel met privately with OraSure to review the results of ongoing clinical studies for its OTC test, and discuss what additional clinical data FDA needs for approval. The firm already markets the OraQuick Advance rapid HIV-12 antibody test, among others

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