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| |  Amplicor HIV-1 Monitor(tm) Test First to Receive FDA Marketing Clearance BRANCHBURG, N.J., June 3, 1996 -- The U.S. Food and Drug Administration (FDA) today approved for marketing Roche Molecular Systems' (RMS) AMPLICOR HIV-1 MONITOR(TM) Test, the first test to accurately and precisely measure quantities of HIV-1 RNA in the blood (viral "load"). Using polymerase chain reaction (PCR) technology, a process that allows the amplification and identification of specific DNA or RNA sequences, the AMPLICOR HIV-1 MONITOR(TM) Test is able to quantitate viral load levels accurately and reproducibly over a broad dynamic range. It is intended for use in conjunction with clinical presentation and other laboratory markers as an indicator of disease prognosis. Research suggests that viral load may be predictive of the clinical progression of HIV disease. The higher the HIV RNA levels, the greater the risk of disease progression, as shown in several ACTG (AIDS Clinical Trials Group) trials. The AMPLICOR HIV-1 MONITOR(TM) Test may identify individuals at highest risk of disease progression -- those with the highest HIV RNA levels. The Test has also been used as an aid in assessing viral response to antiretroviral treatment as measured by changes in plasma HIV RNA levels. The clinical significance of changes in HIV RNA measurements has not been fully established, although several large studies that will more fully determine the role of comparative HIV RNA measurements in patient management are now in progress. HIV RNA levels as measured by the AMPLICOR HIV-1 MONITOR(TM) Test were used as one of the surrogate markers in the accelerated approval process for the protease inhibitor drugs INVIRASE(TM), CRIXIVAN(R) and NORVIR(TM), and for the reverse transcriptase inhibitor drug EPIVIR(TM). Scott Hammer, MD, AIDS clinical trial investigator and Associate Professor of Medicine at Deaconess Hospital and Harvard Medical School in Boston notes, "Clinical research continues to support using viral load as a key indicator in assessing the progression of HIV disease. And, quantitation of plasma HIV RNA is a valuable tool in evaluating a patient's medical status before and during treatment. Hope fully, better understanding of the effectiveness of antiretroviral drugs and the impact of low viral loads on the progression of HIV infection will lead to new therapies and improved disease management." Roche Offers Free Baseline Testing The company also announced the launch of its AMPLICOR(R) ACCESS PROGRAM, which will offer two free HIV RNA baseline tests to all HIV- positive patients in the United States during the next 60 days, starting June 17. A dedicated toll-free hotline, 1-888-TEST PCR, has been established to provide information to patients and physicians wishing to obtain HIV RNA baseline testing by the AMPLICOR HIV-1 MONITOR(TM) assay free-of-charge. First Standardized Test Provides Consistent Results Quickly The AMPLICOR HIV-1 MONITOR(TM) Test quantitates viral loads at levels as low as 400 HIV RNA copies/mL, as compared to other tests which are unable to detect HIV RNA levels lower than 10,000 copies per mL. The test quantitates the amount of virus in a sample by comparison to a reference standard containing a known quantity of synthetic RNA that is added to each specimen. The test requires fewer steps and is less time-consuming than alternative methods. Evaluation of the test results is possible in less than six hours. As the first standardized system that includes all reagents needed for quantitative PCR, the AMPLICOR HIV-1 MONITOR(TM) Test provides reliable results quickly, permitting its use on a large scale by many laboratories. In the past, clinical assessment of anti-HIV therapies relied on indirect markers such as CD4 cell counts to evaluate the drug's antiviral effectiveness. More recently, researchers have proposed HIV RNA as an acceptable marker for evaluating the activity of antiretroviral therapy, such as protease inhibitors, in reducing viral load. Clinical trials of these medications, including Roche's INVIRASE(TM), incorporated quantitative HIV-1 RNA PCR testing, using the AMPLICOR HIV-1 MONITOR(TM) Test along with CD4 cell counts to evaluate antiretroviral efficacy. Roche Molecular Systems: Dedicated to Improving Disease Diagnosis Roche Molecular Systems, a subsidiary of Hoffmann-La Roche Inc., with worldwide headquarters in Branchburg, N.J., develops, manufactures and oversees the commercialization of PCR. Roche Diagnostic Systems is responsible for worldwide sales and distribution of AMPLICOR(R) diagnostic products and for bringing PCR into the clinical diagnostic laboratory. The AMPLICOR HIV-1 MONITOR(R) kit is part of a family of PCR-based test kits, marketed under the trade name AMPLICOR(R) and used in clinical laboratories worldwide. Components of the laboratory-ready kits are pre-packaged, standardized and ready for use.
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