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FDA approves first viral-load test. Food and Drug Administration
Abstract:The Food and Drug Administration (FDA) approved the viral-load test, Roche Molecular Systems' (RMS) Amplicor HIV-1 monitor, to be put on the market in July. The test uses polymerase chain reaction (PCR) technology, which amplifies and identifies specific DNA or RNA sequences and measures the efficacy of all three of the recently approved protease inhibitors. The test, the first of its kind to be approved, will sell for between $150 and $200, depending on individual laboratory fees. Although the test is expensive now, many are hopeful that more tests will receive FDA approval, thus driving down the price. Roche created an access program that will offer two free HIV RNA baseline tests to all HIV-positive patients in the United States during a 60-day period starting June 17.
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