Roche Receives FDA Clearance for Cobas Amplicor HIV-1 Monitor Test; PCR-Based Test Enhances Ability to Measure Viral Loads of HIV Patients

BASEL, Switzerland -- Roche today announced that it has received clearance from the Food and Drug Administration (FDA) for the Cobas Amplicor HIV-1 Monitor Test (version 1.5) an enhanced version of Roche's polymerase chain reaction (PCR) assay used to measure the amount of HIV-1 RNA (viral load) present in an infected person's blood.

The Cobas Amplicor HIV-1 Monitor Test (version 1.5) is an automated assay that amplifies and detects genetic material, allowing for accurate quantification of even small amounts of viral RNA in the blood. This new test can measure viral loads as low as 50 copies of HIV-1 RNA per millilitre (c/mL) of plasma. This level of sensitivity is critical for optimising treatment strategies, because maintaining an infected patient's viral load below 50 c/mL (undetectable) has been associated with a more complete and durable viral suppression. This assay is the automated version of the Amplicor HIV-1 Monitor Test (version 1.5) that received FDA approval last year.

The Cobas Amplicor HIV-1 Monitor Test (version 1.5) also has the enhanced ability to quantify HIV-1 Group M subtypes A-G. While HIV-1 subtype B continues to predominate in Western Countries, studies now confirm that the incidence of HIV-1 non-B subtypes is increasing all over the world. A test's ability to detect a broader range of these genetically diverse viruses will, therefore, be crucial to HIV patient care on a global basis.

"We are very pleased to receive FDA clearance for this newest generation of PCR HIV-1 viral load testing," said Heino von Prondzynski, head of Roche Diagnostics and a member of Roche's corporate executive committee. "The Cobas Amplicor HIV-1 Monitor Test (version 1.5) will allow laboratories to deliver quality HIV viral load results in a shorter time, thanks to cutting edge automation."

According to the World Health Organization, more than 42 million people worldwide were living with HIV at the end of 2002, an infection rate that is expected to increase. The demand for antiretroviral therapy and consequently, viral load testing, is expected to rise accordingly. Roche Diagnostics provides both manual and automated HIV-1 RNA reagent kits and testing systems to laboratories throughout the world.

Source: Roche Molecular Systems, Inc., U.S.