FDA committee approves viral-load test
FDA committee approves viral-load test
The Blood Products Advisory Committee of the U.S. Food and Drug Administration recommended in December that the agency approve the Amplicor HIV-1 Monitor Test for managing HIV disease. Currently, the test is indicated for measuring HIV RNA levels and comparing them with subsequent tests.
The test, manufactured by Roche Molecular Systems Inc. in Branchburg, NJ, is the only FDA-approved commercial test for measuring viral load in the blood. If approved by the FDA, the test would expand its use to monitoring how well antiretroviral drugs act on the virus. AIDS experts say approval also would increase the chances for the test to be covered by insurance companies.
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