The HIV/AIDS community in the U.S. now has access to a newly approved HIV test which will provide a more accurate picture of their disease. Approved by the U.S. Food and Drug Administration (FDA) on July 26, 2002, the AMPLICOR HIV-1 MONITORÒ Test, version 1.5, a product from Roche Diagnostics, is considered to be a highly sensitive measurement of the amount of HIV 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. 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. The ability of a test to detect a broader range of these genetically diverse viruses is therefore crucial to HIV patient care on a global basis.

The new test measures HIV-1 RNA over the range of 50 – 750,000 copies per millilitre. It is the only FDA approved test which can measure HIV-1 RNA down to 50 copies/mL. Clinical practice has shown that lowering plasma HIV RNA to below 50 copies/mL¹ is associated with a more complete and durable viral suppression. With a limited number of treatment regimens available to HIV-1 patients, the accurate monitoring of viral load levels is essential to establish and monitor the effectiveness of therapeutic regimens, assess the potential onset of drug resistance, and identify treatment failure.

"Providing physicians, clinical laboratories and patients with the most advanced HIV diagnostic testing remains paramount to our mission of being a true innovative health information provider," states Heino von Prondzynski, Head of the Roche Diagnostics Division. "It’s not by chance that we are the world-wide market leader in the HIV testing arena," he continues. "Only by responding to the changing face of the AIDS epidemic with state-of-the-art diagnostics technology derived from intensive research efforts are we able to accomplish this, and, in doing so, we hope we’re continuing to make a difference in AIDS patients’ lives."

One such research initiative Roche started in 1998 is their Global Surveillance Program on HIV. Established to collect, identify and sequence divergent HIV isolates from around the world, the program has allowed Roche to stay abreast of subtype changes and use this information to produce new tools, such as the AMPLICOR HIV-1 MONITOR Test, version 1.5, to identify and measure new strains of the AIDS virus. More than 1000 HIV-positive samples have been sequenced to date with the collaboration of several clinical investigators around the world.

Professor Clive Loveday, M.D., Ph.D., Charity Director of the International Clinical Virology Centre, Buckinghamshire, in the U.K., has worked with Roche for a number of years in this regard. Having "field-tested" the developmental stage of the new assay on a population of patients that included a high prevalence of non-B viruses, he comments "We’ve seen a remarkable improvement in the diversity of non-B viruses we could quantify and provide ‘real-time performance’ through our work with this assay." An outgrowth of this research is his current work on the Sentry Study, a two-year surveillance program supported by Roche in which a diverse range of non-B viruses in Europe are being collected and characterized with the AMPLICOR HIV-1 MONITOR Test, version 1.5. The objective of this study will be to ensure that the performance of the Roche assay, and other molecular assays, are maintained over time.

AMPLICORÒ products are based on Roche’s PCR (polymerase chain reaction) technology. In June 1996 and March 1999, respectively, Roche received FDA approval for the AMPLICOR HIV-1 MONITORÒ Test (measuring viral loads at levels as low as 400 HIV-1 RNA copies/mL) and the AMPLICOR HIV-1 MONITORÒ UltraSensitive Method (measuring viral loads down to 50 HIV-1 RNA copies/mL).

During this same time period, Roche introduced the AMPLICOR and COBAS AMPLICOR HIV-1 MONITOR^TM Test, version 1.5, in Europe and other countries outside of the U.S. The COBAS AMPLICOR™ Analyser was the first commercially available system capable of automating critical steps (amplification and detection) of the PCR process. The system improves laboratory productivity and assures results integrity. Roche has filed with the FDA to make this product commercially available in the U.S.

The next generation PCR automated platform, the COBAS AmpliPrep TM System, which automates the entire sample preparation process with specimens then being transferred directly to the COBAS AMPLICOR analyser, is currently being used for research purposes outside of the U.S. This type of instrumentation will also increase the results integrity of HIV viral load testing.

Roche also produces AMPLICORÒ PCR tests for the Hepatitis C and Hepatitis B viruses, tests which are also important to the healthcare community because of the increasing rate of patients infected with these two hepatic viruses.

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