Basel, 11 April 2003

Roche receives FDA clearance for Cobas Amplicor HIV-1 Monitor Test
PCR-based test enhances ability to measure viral loads of HIV Patients

Roche today announced that it has received clearance from the U.S. 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 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.

Roche in HIV
Roche is at the forefront of efforts to combat HIV infection and AIDS, committed since 1986 to groundbreaking research and development of innovative new drugs and diagnostic technology. Saquinavir was the first Protease Inhibitor (PI) and was first introduced by Roche in 1995 in the US. Fuzeon is the first fusion inhibitor, representing the first new class of anti-HIV treatments in seven years. Unlike all currently approved anti-HIV drugs, Fuzeon blocks the virus from entering the human immune cell.

About Roche
Headquartered in Basel, Switzerland, Roche is an innovation driven global healthcare leader focused on pharmaceuticals and diagnostics. Roche is worldwide number one in diagnostics and oncology and has a leading position in virology and transplantation. With products and services that address the prevention, diagnosis and treatment of diseases, the company contributes broadly to the enhancement of people’s health and quality of life. Roche employs some 62,000 people in more than 150 countries around the world. The company has business alliances and R&D relationships with numerous partners, including majority ownership interests in Genentech and Chugai, which are both members of the Roche Group. Roche's Diagnostics Division, the world leader in in-vitro diagnostics with a uniquely broad product portfolio, supplies a wide array of innovative testing products and services to researchers, physicians, patients, hospitals and laboratories worldwide.