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ROCHE RENEWS ITS COMMITMENT TO THE MULTICENTER AIDS COHORT STUDY

Posted: 08-Jul-02

Provides Latest AMPLICOR PCR Assays for the study of HIV, HCV and HBV

Roche Molecular Diagnostics (Roche) announced today that Roche is supporting the expanded Multicenter AIDS Cohort Study (MACS) through March 2004 by providing a significant number of AMPLICOR® PCR (polymerase chain reaction) based assays for detection and quantification of HIV, HCV and HBV. MACS is the largest observational study in the United States of HIV/AIDS in homosexual and bisexual men. It is expected that the use of Roche’s PCR tests will further enhance MACS’ knowledge and understanding of HIV and the AIDS epidemic.

"We gratefully acknowledge Roche’s support of our expanded cohort, which seeks to boost the size of our overall study group by 60 percent and increase the number of minority participants," said John Phair, M.D., Professor of Medicine Emeritus, Northwestern University Medical School and Chairman of the MACS study.

"We have collaborated with MACS since we marketed our first PCR HIV test starting in 1996," commented Heiner Dreismann, Ph.D., Head of Roche Molecular Diagnostics. "As we continue to bring new PCR-based tests and related technologies to the forefront, we believe it is critical to make these products available to important research initiatives like MACS so that they have the most advanced molecular diagnostics methods for their studies," he added.

The AMPLICOR HIV-1 MONITORÒ UltraSensitive Test is the only HIV-1 viral load assay approved for marketing by the U.S. Food and Drug Administration (FDA) to quantify the amount of HIV-1 virus in a person’s blood (viral load) down to 50 copies per milliliter. The test provides physicians with a sensitive measure of HIV viral suppression in patients taking antiretroviral HIV medications.

In addition to receiving AMPLICOR HIV-1 MONITOR UltraSensitive Tests, MACS will also be provided with the AMPLICOR® HCV Test, v 2.0, the first qualitative PCR Hepatitis C test approved by the FDA which can directly measure the presence of Hepatitis C virus in patients who have evidence of liver disease and antibody evidence of HCV infection, and who are suspected to be actively infected with HCV. Roche is also making its AMPLICOR HBV MONITOR® Test (for quantification of Hepatitis B virus, currently for Research Use Only in the U.S.) available to the study’s four sites (UCLA, University of Pittsburgh, Johns Hopkins and Howard Brown Health Center/Northwestern University).

"With the changing face of the HIV population, it’s important that we study patients’ potential co-infection with Hepatitis C or Hepatitis B virus. There is an increasing concern among healthcare providers about hepatic diseases in the HIV/AIDS community because of increased morbidity and mortality as well as limitations of HAART use," commented Dr. Phair.

Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-oriented healthcare groups in the fields of pharmaceuticals, diagnostics and vitamins. Roche’s products and services address prevention, diagnosis and treatment of diseases, thus enhancing well being and quality of life. 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. Roche Molecular Diagnostics, a business area of Roche Diagnostics, has made the polymerase chain reaction (PCR) the leading nucleic acid amplification technology (NAT) in the world. PCR technology allows minute amounts of genetic material to be amplified into billions of copies in just a few hours, thereby facilitating detection of the DNA or RNA of pathogenic organisms even before antibodies to these organisms are formed. Visit us on the web at www.roche-diagnostics.com.

The Multicenter AIDS Cohort Study (MACS), established in 1983 and funded by the National Institute of Allergy and Infectious Diseases and the National Cancer Institute, is a comprehensive observational study designed to answer a broad spectrum of questions related to the natural history of HIV infection and, after the introduction of highly active antiretroviral therapy (HAART) in late 1995, questions related to treated HIV infection. MACS is currently being expanded to increase the group’s overall size and number of minority participants.

For more information please contact:

Paula Evangelista
Roche Molecular Diagnostics
Tel: +1 925 730 8374

Dr. Phair
Multicenter AIDS Cohort Study
Tel: +1 312 695 5090