APPLIED BIOSYSTEMS/BRAZILIAN NMH SIGN PACT FOR GENOTYPING.Applied Biosystems Group (NYSE NYSE See: New York Stock Exchange : ABI Abi (ā`bī) [short for Abijah], in the Bible, King Hezekiah's mother. (Application Binary Interface) A specification for a specific hardware platform combined with the operating system. ), Foster City, Calif., an Applera Corporation business, has signed an agreement to provide its ViroSeq HIV-1 Genotyping Kits to the Brazilian National Ministry of Health for the country's first large- scale study to evaluate the clinical utility of routine genotyping. Genotyping is a sequencing-based testing method used to determine the genetic composition of an organism. Researchers will assess drug resistance in the HIV-1 virus genome. The one-year study, funded in part by the World Bank, will include 6000 tests on patient samples selected from the 120,000 HIV-positive patients treated annually by Brazil's Health Ministry. Patients eligible for the study have twice failed to respond to the Highly Active AntiRetroviral Therapy Noun 1. highly active antiretroviral therapy - a combination of protease inhibitors taken with reverse transcriptase inhibitors; used in treating AIDS and HIV drug cocktail, HAART (HAART HAART highly active antiretroviral therapy. HAART Highly active antiretroviral therapy, triple combination therapy AIDS The concurrent administration of 2 nucleoside reverse transcriptase inhibitors–eg, AZT and 3TC, and a protease ), a drug combination therapy regimen. Currently, 530,000 Brazilians are infected with HIV-1 or AIDS, four-fifths of whom are unaware of their infection. The majority of these patients receive private medical care and are outside the government health system. Applied Biosystems will also lease 12 ABI PRISM 3100 Genetic Analyzers to Health Ministry laboratories to perform the HIV-1 genotyping. "Applied Biosystems is very pleased to be working with the Brazilian Ministry of Health on a project of this importance and magnitude," said Michael Hunkapiller, Ph.D., president of Applied Biosystems. "We believe that genotyping may be a useful tool in identifying drug resistance in the HIV-1 genome. We look forward to participating in this research effort with the Brazilian health authorities to access this new technology in an effort to develop a tool that may improve the quality of life for patients suffering from AIDS." Applied Biosystems is currently conducting clinical trials in the U.S. to prepare the ViroSeq HIV-1 Genotyping System for a 510(k) submission to the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. that would seek market clearance of the system as an in vitro in vitro /in vi·tro/ (in ve´tro) [L.] within a glass; observable in a test tube; in an artificial environment. in vi·tro adj. In an artificial environment outside a living organism. diagnostic tool with a Class II Medical Device designation. The agreement with Brazil stipulates that if the FDA grants market clearance, the Health Ministry ca n then approve the sale of the ViroSeq system to private laboratories in Brazil. Currently, Argentina has approved the ViroSeq system for diagnostic purposes. About Applera Corporation Applera Corporation, formerly PE Corporation, comprises two operating groups. The Applied Biosystems Group develops and markets instrument-based systems, reagents, software, and contract services to the life science industry and research community. Customers use these tools to analyze nucleic acids (DNA DNA: see nucleic acid. DNA or deoxyribonucleic acid One of two types of nucleic acid (the other is RNA); a complex organic compound found in all living cells and many viruses. It is the chemical substance of genes. and RNA RNA: see nucleic acid. RNA in full ribonucleic acid One of the two main types of nucleic acid (the other being DNA), which functions in cellular protein synthesis in all living cells and replaces DNA as the carrier of genetic ), small molecules, and proteins to make scientific discoveries leading to the development of new pharmaceuticals, and to conduct standardized testing. Applied Biosystems is headquartered in Foster City, CA, and reported sales of $1.4 billion during fiscal 2000. The Celera Genomics Group (NYSE: CRA See Community Reinvestment Act. ), headquartered in Rockville, MD, intends to become the definitive source of genomic and related medical information. For more information, call 800.345.5224 or 650.638.5826. |
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