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Highly sensitive and accurate Roche HIV-1 Test approved by FDA


Automated test enables faster results for doctors monitoring treatment response

Roche announced today that the U.S. Food & Drug Administration (FDA) has approved its new HIV-1 test for diagnostic use in the United States. The highly accurate Cobas AmpliPrep/Cobas TaqMan HIV-1 Test is the first fully automated HIV-1 diagnostic tool using real-time PCR technology in the US. It 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.

“This approval represents a significant milestone in the automation of our virology platform in the US market”, said Severin Schwan, CEO of Roche Diagnostics and a member of the Roche Group’s Executive Committee. “The new test system provides innovative options for combining a more sensitive HIV test with full automation that simplifies state-of-the-art molecular diagnostic testing.”

The 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 with over 5,000 participants with viral load monitoring had shown a significant association between a decrease in plasma viremia and improved clinical outcome.

According to the U.S. Centers for Disease Control and Prevention, each year in the US approximately 40,000 become infected with HIV. The agency estimates that at the end of 2003, approximately 1 million Americans were living with HIV/AIDS, and that approximately 300,000 more remained unaware of their HIV infections.


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