FDA Advisory Committee Approves Expanded Use of RNA HIV-1 Test

Important note: Information in this article was accurate in 1997. The state of the art may have changed since the publication date.

FDA Advisory Committee Approves Expanded Use of RNA HIV-1 Test

Reuters Health Information Services (12/15/97)

Abstract: Roche Diagnostics Systems' Amplicor HIV-1 Monitor Test, which will be used to monitor antiretroviral treatment for HIV, has been approved by the Food and Drug Administration's Blood Products Committee. The test is currently the only one commercially available to help measure plasma HIV-1 load; it does this by comparing baseline HIV-1 RNA levels over time. Roche also has plans to submit its Ultrasensitive Method for the Amplicor HIV-1 test to the FDA early next year. The Ultrasensitive test will measure HIV-1 RNA levels that fall below 400 copies per milliliter of plasma.

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