Celera Diagnostics Gains Additional FDA Clearance For ViroSeq™ HIV-1 Genotyping System
Distributed by Abbott Laboratories, System Is Now Available
Alameda, CA and Abbott Park, IL - June 25, 2003
Celera Diagnostics, a joint venture between the Applied Biosystems Group (NYSE:ABI) and Celera Genomics Group (NYSE:CRA) of Applera Corporation, and Abbott Laboratories (NYSE:ABT) today announced that the U.S. Food and Drug Administration granted an additional marketing clearance for the ViroSeq™ HIV-1 Genotyping System, a molecular diagnostic test designed to detect mutations in the HIV-1 virus that are associated with drug resistance. This latest 510(k) clearance covers the use of the ViroSeq™ System with the ABI PRISM® 3700 DNA Analyzer, a fully automated instrument commonly used in the largest, high-throughput clinical testing laboratories.
Physicians use the ViroSeq™ System as an aid in monitoring and treating HIV infection. It was first cleared for marketing as an in vitro diagnostic in December 2002 for use with the ABI PRISM® 377 DNA Sequencer and was cleared in January 2003 for the ABI PRISM® 3100 Genetic Analyzer.
“Now, the ViroSeq™ System is available across a range of instrument platforms, making it readily accessible to smaller laboratories, mid-size reference laboratories and hospitals, and the largest clinical reference laboratories,” said Gene Cartwright, Ph.D., Divisional Vice President, Molecular Diagnostics for Abbott Laboratories.
Clinical studies required for the FDA clearance were conducted at Laboratory Corporation of America (NYSE:LH) and Quest Diagnostics Incorporated (NYSE: DGX), the nation’s two largest clinical laboratories. “By participating as clinical sites in this study, these companies demonstrated their commitment to HIV genotyping testing and the benefits it provides in assisting physicians to make treatment decisions,” said Kathy Ordoñez, President of Celera Diagnostics.
The ViroSeq™ System is manufactured by Celera Diagnostics and distributed exclusively by Abbott Laboratories through a previously announced strategic alliance. In June 2002, Abbott Laboratories and Celera Diagnostics announced a long-term strategic alliance to develop, manufacture and market a broad range of in vitro molecular diagnostic products for disease detection, disease progression monitoring and therapy selection.
The ViroSeq™ System consists of an Applied Biosystems automated DNA sequencing instrument and Celera Diagnostics’ reagents that are used to identify key strains of the HIV-1 virus. The system targets specific regions of the viral genome associated with drug-resistant mutations. Genotyping is a sequencing-based testing method routinely used by laboratories and clinicians to determine the genetic composition of the HIV virus. Applied Biosystems sequencing instruments are currently used for a majority of the more than 150,000 HIV genotyping tests performed in the United States each year.
About Abbott Laboratories
Abbott Laboratories has been a leader in HIV/AIDS research since the early years of the epidemic. In 1985, the company developed the first licensed test to detect HIV antibodies in the blood, and remains the leader in HIV diagnostics. Abbott retroviral and hepatitis tests are used to screen more than half of the world's donated blood supply.
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals, nutritionals, and medical products, including devices and diagnostics. The company employs approximately 70,000 people and markets its products in more than 130 countries. For more information on Abbott, please visit the company's Web site at www.abbott.com.
About Celera Diagnostics and Applera Corporation
Celera Diagnostics is a 50/50 joint venture between two Applera Corporation businesses, Applied Biosystems and Celera Genomics. Headquartered in Alameda, CA, Celera Diagnostics focuses on discovering novel genetic markers for disease and configuring these into new diagnostic tests to predict, characterize, monitor and select therapy for cardiovascular disease, auto-immunity, central nervous system disorders, and cancer. 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 and RNA), small molecules, and proteins to make scientific discoveries, develop new pharmaceuticals, and conduct standardized testing. Applied Biosystems is headquartered in Foster City, CA, and reported sales of $1.6 billion during fiscal 2002. The Celera Genomics Group, located in Rockville, MD, an d South San Francisco, CA, is engaged principally in integrating advanced technologies to discover and develop new therapeutics. Celera intends to leverage its proteomics, bioinformatics, and genomics capabilities to identify and validate drug targets, and to discover and develop novel therapeutic candidates. Its Celera Discovery System™ online platform, marketed exclusively through the Applied Biosystems Knowledge Business, is an integrated source of information based on the human genome and other biological and medical sources. Information about Applera Corporation, including reports and other information filed by the company with the Securities and Exchange Commission, is available at www.applera.com, or by telephoning 800.762.6923.
For Abbott: Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. Abbott cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Economic, competitive, governmental, technological and other factors that may affect Abbott's operations are discussed in Exhibit 99.1 of our Form 10-Q for the period ended September 30, 2002 and are incorporated by reference. Abbott undertakes no obligation to release publicly any revisions to forward-looking statements as the result of subsequent events or developments.
For Celera Diagnostics: Certain statements in this press release are forward-looking. These may be identified by the use of forward-looking words or phrases such as "believe," "expect," "plan," and "should," among others. These forward-looking statements are based on Applera Corporation’s current expectations. The Private Securities Litigation Reform Act of 1995 provides a "safe harbor" for such forward-looking statements. In order to comply with the terms of the safe harbor, Applera 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. These factors include but are not limited to (1) unproven ability of Celera Diagnostics and Abbott to successfully manage and operate the alliance; (2) uncertainty in obtaining intellectual property protection for inventions made by the alliance, and uncertainty in obtaining any necessary third party intellectual property licenses; (3) u nproven ability of the alliance to discover, develop, and commercialize diagnostic products; (4) unproven use of genomics information to develop diagnostic products; (5) uncertainty as to whether the alliance will be able to obtain any required regulatory approval of its diagnostic products; (6) uncertainty of market acceptance of the alliance’s products; (7) possibility of delays in making Celera Diagnostics’ manufacturing facility fully operational and unproven ability to scale up manufacturing as product sales increase; (8) availability and pricing of certain raw materials and equipment; and (9) other factors that might be described from time to time in Applera’s filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Applera does not undertake any duty to update this information, including any forward-looking statements, unless required by law.
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