Applied Biosystems, Brazilian National Ministry of Health Sign Agreement for Large-Scale, HIV-1 Genotyping Study.Business Editors & Health/Medical Writers FOSTER CITY, Calif.--(BW HealthWire)--May 2, 2001 Trial Will Assess Utility of Routine Genotyping in Drug-Resistance 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. ), an Applera Corporation business, announced today that it will provide its ViroSeq(TM) 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 6,000 tests that will be performed on samples from patients selected from the 120,000 HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. positive patients treated annually by Brazil's Health Ministry. Patients eligible for the study are those that 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 which do not know that they are infected. The majority of these patients receive treatment outside of the government health system through private medical care. Applied Biosystems will also lease 12 ABI PRISM(R) 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 W. 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 can 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 Nucleic acids The cellular molecules DNA and RNA that act as coded instructions for the production of proteins and are copied for transmission of inherited traits. (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, 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. Information about the company, including reports and other information filed by the company with the Securities and Exchange Commission, is available on the World Wide Web at www.applera.com or by telephoning 800/762-6923. Certain statements in this press release are forward-looking and subject to a variety of risks and uncertainties. These may be identified by the use of forward-looking words or phrases such as "believe," "expect," "intend," "anticipate," "should, "estimated," and "potential," among others. These forward-looking statements are based on Applera Corporation's current expectations. The Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995 provides a "safe harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. " for such forward-looking statements. In order to comply with the terms of the safe harbor, Applera Corporation notes that a variety of factors could cause actual results and experience to differ materially from the anticipated results or other expectations expressed in such forward-looking statements. The risks and uncertainties that may affect the operations, performance, development, and results of Applied Biosystems businesses include but are not limited to (1) sales dependent on customers' capital spending policies and government-sponsored research; (2) government regulatory approvals and (3) other factors that might be described from time to time in Applera Corporation's filings with the Securities and Exchange Commission. Note to Editors: Applera, Celera, Celera Genomics, and ViroSeq are trademarks, and ABI PRISM and Applied Biosystems are registered trademarks of Applera Corporation or its subsidiaries in the U.S. and certain other countries. |
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