US FDA approves Roche's new HIV diagnostic

Swiss drug major Roche says that the US Food and Drug Administration has approved its new HIV-1 test for diagnostic use. The highly-accurate Cobas AmpliPrep/Cobas TaqMan HIV-1 Test is the first fully-automated HIV-1 diagnostic using real-time polymerase chain reaction technology in the USA.

According to Roche, the product provides a broader range of viral load data than earlier generation tests, quantifying the amount of virus in the blood from very high to very low levels. With the test, labs can deliver highly accurate results faster - a decisive advantage for doctors monitoring how well a chosen therapy is working for the patient. Roche noted that its new test can be used to assess patient prognosis by measuring the baseline HIV-1 RNA level or to monitor the effects of antiretroviral therapy during the treatment course. One key goal of therapy is a viral load below the limits of detection of approved molecular diagnostic tests. Analysis of 18 trials including over 5,000 participants with viral load monitoring had shown a significant association between a decrease in plasma viremia and improved clinical outcome, the firm added.