On Friday, December 15, 1997 the US Food and Drug Administration's Blood Products Committee unanimously approved expanded use of the Amplicor HIV-1 Monitor test for use as an aid in the management of patients on antiretroviral treatment for HIV disease, according to Roche Diagnostic Systems.
The Amplicor HIV-1 Monitor is currently the only commercially available test designed to measure plasma HIV-1 load. It has already been approved for use in prognostic assessment of HIV-positive patients. The Amplicor HIV-1 Monitor compares baseline HIV-1 RNA levels with subsequent levels over time, according to a company press release.
Friday's FDA committee approval follows submission of an application by the company in June of this year, at which time the company requested expanded use of the HIV-1 RNA assay to include therapeutic monitoring.
The company next plans to submit additional data to the FDA in early 1998 regarding a new Ultrasensitive Method for the Amplicor HIV-1 Monitor test. The Ultrasensitive test is designed to quantitate HIV-1 RNA levels lower than 400 copies per milliliter of plasma, which is the current assay's limit of sensitivity.
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