BRANCHBURG, NJ--Roche Diagnostic Systems Inc.'s Amplicor H.I.V.-1 monitor test for use in determining viral load in individuals infected with HIV has received FDA approval for marketing. The test uses polymerase chain reaction (PCR) technology to measure HIV genetic material in the blood.
In laboratory studies, the Amplicor test was able in some cases to detect as few as 400 copies of HIV DNA in a blood sample and could regularly detect 800 or more copies.
Two clinical trials of Amplicor were conducted in patients with advanced HIV infection who had received no antiviral treatment or treatment for less than 16 weeks. The results showed that high viral load before anti-HIV therapy, or large increases in viral load after treatment, correlated with increased risk of disease progression to full-blown AIDS.