Abbott and Celera Diagnostics Announce CE Marking for HCV Real-Time PCR Viral Load Test

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Abbott and Celera Diagnostics Announce CE Marking for HCV Real-Time PCR Viral Load TestFriday July 22, 2:00 am ET

- Highly Sensitive Molecular Test Provides Valuable Tool for Measuring HCV in Serum and Plasma, Helping Physicians to Effectively Manage Patient Therapy -

DELKENHEIM, Germany, July 22 /PRNewswire-FirstCall/ -- Abbott and Celera Diagnostics, a joint venture between the Applied Biosystems Group and Celera Genomics Group of Applera Corporation, today announced that Abbott has received CE Mark certification for a real-time PCR (polymerase chain reaction) test for monitoring hepatitis C (HCV) viral load in patients, allowing the test to be marketed in the European Union. This test is not available or approved for use in the United States.

Quantitative measurements of HCV levels in plasma or serum have been shown to be an essential parameter in the prognosis and management of HCV infected individuals. An initial measurement of HCV viral load can guide a decision to begin antiviral therapy, while monitoring HCV RNA levels during therapy can influence its duration. The Abbott RealTime HCV assay has been developed for use on the Abbott m2000 system, an automated instrument using real-time PCR technology provided by Applied Biosystems. "One of the key impediments of molecular testing we've addressed with the Abbott m2000 system is the complex and heavily manual procedures required, from the preparation of patient samples to the analysis of data," said , president, Abbott Molecular. "By taking automation to another level, we're helping molecular laboratories deliver patients' test results faster, easier and more accurately." The Abbott m2000 system purifies the nucleic acid (RNA) from the specimen and automatically combines this with the assay reagents. The system's software has been specifically designed to be user-friendly and data are automatically calculated to provide highly reliable patient results for HCV viral load testing. In real-time PCR, the amplified DNA sequences are detected throughout the PCR process, instead of at the end of the amplification process. The instrument and reagents allow laboratories to provide highly accurate test results more quickly, increase productivity and help reduce human error, resulting in consistent and reproducible results. "The Abbott RealTime HCV assay builds upon Abbott's 34 years of experience in hepatitis diagnostics and provides another level of confidence in testing for laboratories, physicians and patients," said , Ph.D., director of research and development, Abbott Molecular. "It is among the most sensitive viral load tests available today, with a broad dynamic range, capable of detecting HCV RNA in plasma down to as few as 12 IU (international units) of HCV RNA per milliliter. With a broad dynamic range that quantitates (precisely measures HCV levels) specimens as high as 100 million IU of RNA per milliliter, the need for sample dilutions and additional testing is virtually eliminated." "Given the reproducibility and precision of this test to quantitate HCV RNA levels across a broad dynamic range, physicians can be confident about assessing viral levels in their patients and determining the most appropriate course of therapy," said Carsten Tiemann, Ph.D., director, molecular diagnostics, Laboratory Dr. Krone & Partner, Germany. In June, Abbott and Celera Diagnostics announced CE Mark certification of the Abbott RealTime HIV-1 assay for the Abbott m2000 system. Additional tests are in development for the system, including methods for detecting hepatitis B, chlamydia and gonorrhea. "The CE certification of both our HIV-1 and HCV real-time assays represents an important step in our commitment to enhancing molecular testing through a growing portfolio of automated assays," said Kathy Ordonez, president, Celera Diagnostics. "Reliable and accurate quantitation of HIV-1 and HCV are an integral part of the disease management process. We believe that our exclusive partnership with Abbott in molecular diagnostics continues to deliver products that improve the capacity and sensitivity in clinical testing, enabling medical practitioners to make better choices in therapeutic selection that improve outcomes for patients." Hepatitis C is a bloodborne pathogen and a frequent cause of chronic viral hepatitis in the world. The World Health Organization estimates that more than 170 million people worldwide are infected with hepatitis C. Often called the "silent epidemic," many individuals infected with the virus have no signs or symptoms of the disease until chronic infection or chronic liver disease has developed. Additionally, there is no vaccine to prevent HCV. About Real-Time PCR Real-time PCR is a modification of standard PCR, which is often compared to the photocopying of nucleic acid (DNA or RNA). The process involves the alternate heating and cooling of a small sample containing a segment of nucleic acid molecules dozens of times over several hours. Throughout this process, copies of these DNA molecules are "amplified" or exponentially increased so that the nucleic acid can be more readily analyzed. The method is called "real-time PCR" because the amplified DNA can be detected during the PCR process, in real time, rather than at the end of the process. This ensures more accurate and precise quantification of nucleic acid. The real-time PCR reaction proceeds automatically with no user intervention, providing increased productivity and reduced opportunity for human error, resulting in consistent and reproducible results. About the Abbott/Celera Diagnostics Alliance In 2002, Abbott and Celera Diagnostics, a joint venture between the Applied Biosystems Group and the Celera Genomics Group of Applera Corporation, entered into 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 alliance develops and commercializes molecular diagnostic products to detect and manage infectious diseases and chronic conditions including autoimmune and cardiovascular diseases, central nervous system disorders and cancer. Celera Diagnostics' focus is primarily on assay development and genetic marker discovery and validation. Abbott's focus is on product development and sales and marketing, serving as the worldwide distributor for most products developed by the alliance. About Celera Diagnostics and Applera Corporation Celera Diagnostics, a 50/50 joint venture between Applied Biosystems and Celera Genomics, is focused on discovery, development, and commercialization of diagnostic products. 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 City, CA, and reported sales of $1.7 billion during fiscal 2004. The Celera Genomics Group is engaged principally in the discovery and development of targeted therapeutics for cancer, autoimmune and inflammatory diseases. Celera Genomics is leveraging its proteomic, bioinformatic, and genomic capabilities to identify and validate drug targets, and to discover and develop small molecule therapeutics. It is also seeking to advance therapeutic antibody and selected small molecule drug programs in collaboration with global technology and market leaders. Information about Applera Corporation, including reports and other information filed by the company with the Securities and Exchange Commission, is available at http://www.applera.com , or by telephoning 800.762.6923. Information about Celera Diagnostics is available at http://www.celeradiagnostics.com . About Abbott Abbott (NYSE: ABT - News) is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 60,000 people and markets its products in more than 130 countries. Abbott's news releases and other information are available at the company's web site at http://www.abbott.com. Applera Corporation's Forward-Looking Statement 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 that the Abbott RealTime HIV-1 assay or the m2000 system will be accepted by the market, including the risk that these products will not be competitive with products offered by other companies; 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.

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