In Brief: Roche Amplicor
This article was originally published in The Gray Sheet
Executive Summary
Roche Amplicor: Use of Roche Molecular Systems' quantitative HIV-1 RNA test "as an aid in management of patients on antiviral therapy for HIV disease" should be approved, FDA's Blood Products Advisory Committee determines at a Dec. 12 meeting in Rockville, Maryland. The Amplicor test kit was approved in June 1996 as a prognosis test only ("The Gray Sheet," June 10, 1996, p. 3)...