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| |  Amplicor HIV Monitor Test Recommended for Approval by FDA BRANCHBURG, N.J., March 22, 1996 -- Roche Molecular Systems, Inc. announced that the consensus of the Blood Products Advisory Committee of the U.S. Food and Drug Administration (FDA) today was to approve their AMPLICOR HIV-1 MONITOR(TM) test as an accurate and precise measure of RNA in the blood. The test reviewed by the committee is the first such quantitative test which monitors viral RNA levels in the blood of patients with confirmed HIV infection by using polymerase chain reaction (PCR) technology. The AMPLICOR HIV-1 MONITOR is intended for use in conjunction with other laboratory markers as an indicator of HIV disease prognosis and as an aid in monitoring the effects of antiretroviral therapy on viral levels in the blood. Use of the test in managing disease in patients will be based on more clinical experience to develop guidelines for physicians. Recent clinical studies suggest that the viral "load" (or quantity of HIV RNA in the blood) is predictive of the clinical progression of HIV disease. The higher the HIV RNA levels, the greater the risk of disease progression. [Rev. by Mascolini M. "J Int Assoc Physicians AIDS Care." 1996; Jan: 6-9.] The AMPLICOR HIV-1 MONITOR can detect viral loads as low as 400 HIV RNA copies/mL. In addition, the AMPLICOR HIV-1 MONITOR test is a method to identify individuals at highest risk of disease progression -- those with the highest HIV RNA levels -- and to understand whether maintaining low viral loads results in a clinical improvement. Test played role in FDA accelerated approval of protease inhibitors In the past, clinical tests of anti-HIV therapies have relied on indirect markers such as CD4 cell counts to evaluate the drug's effectiveness. More recently, researchers have proposed HIV RNA as an acceptable marker for the activity of antiretroviral therapy in reducing viral load. Clinical trials of the protease inhibitors (including Roche's INVIRASE(TM)) -- the first new class of HIV/AIDS therapeutics to be introduced since 1987 -- incorporated quantitative HIV RNA testing using PCR along with CD4 cell counts to evaluate efficacy. The FDA accelerated approval of protease inhibitors has in part been based on AMPLICOR HIV-1 MONITOR determinations of viral load obtained during these trials. Prior to the development of the AMPLICOR HIV-1 MONITOR test, there was no way to study the effects of very low viral loads, since other standardized tests were unable to detect levels lower than 10,000 copies per mL. Scott Hammer, MD, AIDS clinical trial investigator and Associate Professor at Deaconess Hospital and Harvard Medical School in Boston, stated, "Many of the newer antiretroviral therapies create a dramatic drop in viral load -- and it's important for us to monitor viral load with as much sensitivity as possible. Monitoring HIV viremia is vitally important now that new anti-HIV therapies are becoming available, and PCR has shown potential as a powerful prognostic tool. Consistent results make PCR technology accessible The AMPLICOR HIV-1 MONITOR test incorporates a number of unique elements that assist in rigorous quality control. These controls, and the standardization of test reagents, will allow laboratories throughout the country to perform the test and achieve comparable results when it is approved. Clinicians can feel more confident that the results are valid and reproducible. This, in turn, would make an extremely sophisticated test accessible and useful to a large number of patients. PCR is a new technology that allows the amplification and identification of specific DNA or RNA sequences, including the genetic sequences in HIV (HIV RNA). Using PCR, technicians in clinical laboratories can produce billions of DNA copies of the RNA from a single segment of the HIV genome. Quantitative tests, such as the AMPLICOR HIV-1 MONITOR test, allow determination of the amount of virus in the sample in comparison with a reference standard (each sample includes a known quantity of a synthetic RNA). Alternative PCR methods, such as "home brew assays," and other amplification methods that measure HIV require numerous steps and are time-consuming. Previous tests have also lacked consistent results, limiting their use on a large scale. The AMPLICOR HIV-1 MONITOR test kit is the first standardized system that includes all reagents needed for quantitative PCR, including sample preparation, application of the reverse transcription and PCR amplification process, and detection and quantitation of the HIV viral levels. Evaluation of the AMPLICOR HIV-1 MONITOR test results is possible in less than 6 hours by a single technician. Roche Molecular Systems, Inc.: Dedicated to Improving Disease Diagnosis Roche Molecular Systems, Inc., a subsidiary of Hoffmann-La Roche Inc., with worldwide headquarters in Branchburg, NJ, develops, manufactures and oversees the commercialization of PCR. Roche Diagnostic Systems is responsible for worldwide sales and distribution of the AMPLICOR(R) diagnostic products and for bringing polymerase chain reaction (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 and used in clinical laboratories worldwide. Components of the laboratory-ready kits are pre-packaged, standardized, and ready for use.
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