ROCHE AMPLICOR QUANTITATIVE HIV TEST APPROVAL FOR PATIENT MONITORING RECOMMENDED BY FDA ADVISORY PANEL; PMA SUPPLEMENT BASED ON AIDS DRUG STUDY
This article was originally published in The Gray Sheet
Executive Summary
Roche Molecular Systems' Amplicor HIV-1 Monitor test kit should be approved as an aid in managing patients receiving anti-viral therapy for HIV infection, FDA's Blood Products Advisory Committee unanimously concluded at a Dec. 12 meeting in Rockville, Maryland.