Celera Diagnostics Announces New Regulatory Clearances for ViroSeq™ HIV-1 Genotyping System
Upgraded Software Now Available in the United States; CE Mark Certification Completed for Europe
ALAMEDA, CA - February 10, 2004
Celera Diagnostics, a joint venture between the Applied Biosystems Group (NYSE:ABI) and Celera Genomics Group (NYSE:CRA) of Applera Corporation, today announced that it has obtained special 510(k) clearance from the U.S. Food and Drug Administration for expanded claims related to its ViroSeq™ HIV-1 Genotyping System, a molecular diagnostic test designed to detect mutations associated with drug resistance in HIV-1, the virus that causes AIDS.
The ViroSeq™ System, marketed worldwide through an alliance with Abbott Laboratories, includes an updated software algorithm that analyzes information regarding known and newly identified mutations in HIV-1, nineteen anti-retroviral drugs, and reported drug resistance patterns. Four drugs have been added to the updated software algorithm: tenofovir (Viread®), emtricitabine (EmtrivaTM), fosamprenavir (LexivaTM), and atazanavir (ReyetazTM). 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, and the ABI PRISM® 3100 Genetic Analyzer.
“We’re pleased that the ViroSeq System now predicts resistance to four additional HIV therapies,” said Delbert A. Fisher, M.D., Vice President, Science and Innovation at Quest Diagnostics. “This advance is critical to our customers seeking an FDA-cleared test that detects resistance to the greatest variety of HIV treatments.”
“Since the introduction of anti-retroviral drugs and diagnostic procedures such as HIV genotyping, life expectancy and quality of life have improved for many HIV infected patients,” said Kathy Ordoñez, president of Celera Diagnostics. “These latest regulatory clearances for the ViroSeq System reflect our commitment to upgrade our products to keep pace with new innovations and the requirements of our laboratory customers and the physicians and patients they serve.”
Celera Diagnostics also obtained CE mark certification for the ViroSeq System on January 15, 2004. With this certification, the ViroSeq System meets the requirements of the European Union’s In Vitro Diagnostic Directive (IVDD) and may be sold in the 18 member states of the European Economic Area (EEA). The ViroSeqTM HIV-1 Genotyping System currently offered in the member states of the EEA does not include the upgraded software algorithm mentioned above. The company plans to pursue CE marking for the upgraded algorithm.
Physicians use the ViroSeq™ HIV-1 Genotyping System as an aid in monitoring and treating HIV infection. The ViroSeq System consists of an Applied Biosystems automated DNA sequencing instrument and Celera Diagnostics’ reagents that are used to identify key strains of HIV-1. The system targets specific regions of the viral genome associated with drug-resistant mutations. Clinicians and laboratories routinely use sequencing-based genotyping to determine the genetic composition of the HIV virus. Approximately 180,000 HIV genotyping tests are performed in the United States each year.
In 2002, Celera Diagnostics and Abbott Laboratories formed an alliance focused on developing and marketing a broad menu of next-generation molecular diagnostic products for unmet diagnostic needs. Abbott's emerging molecular diagnostics provides physicians with important information allowing for earlier diagnosis, selection of appropriate therapies and monitoring of disease progression. The business includes instruments and reagents used to conduct sophisticated analysis of patient DNA and RNA. Abbott Laboratories has been a leader in HIV/AIDS research since the early years of the epidemic. In 1985, Abbott developed the first licensed test to detect HIV antibodies in the blood, and remains a leader in HIV diagnostics.
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 Celera Genomics Group, located in Rockville, MD, and 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 by Applied Biosystems, is an integrated source of information based on the human genome and other biological and medical sources. The Applied Biosystems Group serves the life science industry and research community by developing and marketing instrument-based systems, consumables, software, and services. 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 $1.7 billion during fiscal 2003. 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.
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," "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) uncertainty as to whether Celera Diagnostics will be able to obtain any required regulatory approval of its diagnostic products, including CE Marking for its upgraded algorithm for the ViroSeq System; and (2) 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.
Copyright© 2004. Applera Corporation. All rights reserved. Applied Biosystems and ABI PRISM are registered trademarks and Applera, Celera, Celera Diagnostics, Celera Genomics, ViroSeq, and Celera Discovery System are trademarks of Applera Corporation or its subsidiaries in the US and/or certain other countries.
Viread is a registered trademark and Emtriva is a trademark of Gilead Sciences, Inc. Lexiva is a trademark of GlaxoSmithKline. Reyetaz is a trademark of Bristol-Myers Squibb.
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