PLEASANTON, CALIFORNIA, July 2, 2002 �
A two-year research surveillance program has commenced between the International Clinical Virology Centre (ICVC), Buckinghamshire, U.K. and Roche Molecular Diagnostics, entitled the SENTRY Study. The study will examine a diverse range of HIV-1 non-B viruses in the U.K. with patient specimens being collected and characterized using various genetic tools such as sequencing and viral load testing, including Roche�s AMPLICOR HIV-1 MONITOR� Test, version 1.5. Sponsored by Roche Diagnostics, the objective of the study is to ensure that the performance of this and future Roche assays, and other molecular assays, maintain their reliability over time by evaluating the scope and evolution of these diverse HIV-1 viruses.
As the HIV-1 virus is constantly mutating and evolving, it is important to continuously document these genetic variations in order to develop the next generation diagnostic tests that will still ensure results integrity despite these changes. Originally, molecular diagnostic tests were developed chiefly for the identification and monitoring of HIV-1 subtype B virus, the most common subtype of this virus found predominantly in Western Countries. Researchers, however, are now seeing a quantal shift in the virus where non-B viruses are actually dominant in certain populations, regardless of where a patient lives.
"We are in dire need of guarding against the effects of new non-B viruses and need to act now to preempt related problems. If we don�t do so, HIV/AIDS patients� clinical outcomes, such as treatment efficacy and viral load and resistance testing, will be greatly compromised," comments Professor Clive Loveday, M.D., Ph.D., Charity Director of the International Clinical Virology Centre, and project leader of the SENTRY Study. "Roche Diagnostics is truly demonstrating their commitment to support clinical research in the field of HIV through the funding of this project. Using the Roche test, we have the ability to monitor in �real time� these emerging HIV-1 viruses and ultimately help assure patients that in the future, they will get the most accurate test to quantitate their virus, no matter which subtype of the virus they have, " Dr. Loveday continues.
Six to eight hundred patient specimens obtained from the Royal Free Hospital in London and 40 other hospitals across the U.K. will be analyzed over the course of the next two years. According to Dr. Loveday, the U.K. has become a "melting pot" of HIV-1 viral subtypes and he is anticipating seeing very useful results from this patient population. Dr. Loveday will characterize the population that the Sentry Study is investigating during a presentation at the upcoming XIV International AIDS Conference in Barcelona this July.
"With the globalization of the HIV epidemic, we�re hopeful that the information obtained from this important scientific collaboration will result in our providing physicians, clinical laboratories and patients alike with the most advanced PCR tests that will perform well across all HIV-1 viral subtypes," says Heiner Dreismann, Ph.D., Head of Roche Molecular Diagnostics.
About the AMPLICOR HIV-1 MONITOR� Test, version 1.5
The AMPLICOR HIV-1 MONITOR Test, version 1.5, manufactured by Roche Diagnostics, provides sensitive measurements for the detection of the AIDS virus circulating in an infected person�s blood ("viral load"). Equally as important, the test has the enhanced ability to quantitate HIV-1 Group M subtypes A-G of the virus. This includes HIV-1 non-B viruses.
Roche�s AMPLICOR� products are based on the Company�s PCR (polymerase chain reaction) technology. In June 1996 and March 1999, respectively, Roche received FDA approval for the AMPLICOR HIV-1 MONITOR� Test (measuring viral loads at levels as low as 400 HIV-1 RNA copies/mL) and the AMPLICOR HIV-1 MONITOR � UltraSensitive Method (measuring viral loads down to 50 HIV-1 RNA copies/mL).
About Roche and the Roche Diagnostics Division
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 world-wide. 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. Roche Diagnostics� website is located at
