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

Pleasanton, California

May 10, 2007

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. Centres 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.

About the Cobas AmpliPrep/Cobas TaqMan HIV Test

The new test is designed for use on an automated platform that combines the Cobas AmpliPrep instrument for automated sample preparation and the Cobas TaqMan analyser or smaller Cobas TaqMan 48 analyser for automated real-time PCR amplification and detection. Configuration options also include docked instruments for “sample in/results out” testing that eliminates manual intervention between steps. The combined instrument platform fully automates the sample preparation and real-time PCR amplification and detection process for improved workflow efficiency, hands-off processing, and test results integrity. Each Roche test includes AmpErase® enzymes designed to prevent cross-contamination of samples or labs.

The test is intended for use in conjunction with clinical presentation and other laboratory markers of disease progress for the clinical management of HIV-1 infected patients. It can be used to assess patient prognosis by measuring the baseline HIV-1 RNA level or to monitor the effects of antiretroviral therapy by measuring changes in EDTA plasma HIV-1 RNA levels during the course of antiretroviral treatment. The test is not intended for use as a screening test for the presence of HIV-1 in blood or blood products or as a diagnostic test to confirm the presence of HIV-1 infection.

About Roche Diagnostics Virology Test Portfolio

Roche Molecular Diagnostics (RMD), the global leader in molecular diagnostics, develops tests in a broad range of areas based on the company’s Nobel Prize-winning PCR technology. The company’s tests for HIV-1 and Hepatitis B & C provide actionable health information designed to help improve disease management through diagnosis of active infections, quantification of the amount of virus in the blood (viral load monitoring), and identification of drug resistance and disease recurrence. The Cobas AmpliPrep/Cobas TaqMan HIV-1, HCV, and HBV tests have been available in Europe since 2005. The HIV-1 test is the first on this automated platform approved for use in the US. The HCV test for this platform is currently under review by the US FDA. The agency is also currently reviewing the Roche Diagnostics Cobas TaqMan HBV Test, which is designed for use with High Pure sample preparation reagents and the Cobas TaqMan 48 analyser for automated amplification and detection of Hepatitis B virus in human blood.

About Roche and the Roche Diagnostics Division

Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world’s biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche is a world leader in diagnostics, the leading supplier of drugs for cancer and transplantation and a market leader in virology. In 2006 sales by the Pharmaceuticals Division totaled 33.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.7 billion Swiss francs. Roche employs approximately 75,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Roche’s Diagnostics Division offers a uniquely broad product portfolio and supplies a wide array of innovative testing products and services to researchers, physicians, patients, hospitals and laboratories world-wide. For further information about Roche, please visit our website


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For Further Information

Melinda Baker
Roche Molecular Diagnostics
+1 925.730.8379