Abbott Laboratories's RealTime Hepatitis B Viral Load Test Receives CE Marking in Europe
The Abbott RealTime HBV test, developed for use on the Abbott m2000(TM) automated instrument system, is designed for the quantitation (precise measurement) of HBV in human plasma or serum from patients known to be infected with the virus. It is intended for use in conjunction with clinical presentation and other laboratory markers as an indicator of disease prognosis and as an aid in assessing a patient's response to antiviral treatment. With the addition of the HBV test, the m2000 offers the broadest menu of molecular tests available on a single instrument platform. The m2000 menu includes real-time PCR tests for HIV-1, hepatitis C, chlamydia, and a combination test for chlamydia and gonorrhea.
Quantitative measurements of HBV levels in plasma or serum have been shown to be an essential parameter in the prognosis and management of patients with HBV. An initial measurement of HBV viral load can guide a decision to begin antiviral therapy, while monitoring HBV DNA levels during therapy can influence its duration and also signal the development of drug resistance.
In addition, the higher the baseline viral level the more likely a patient is to develop hepatocellular carcinoma, a primary cancer of the liver.
"The Abbott RealTime HBV assay is the only test currently available that targets an essential, highly conserved segment of the HBV genome, which makes it a very reliable test for detecting and measuring all known HBV genotypes," said John Robinson, Ph.D., senior director, research and development, Abbott Molecular. "It gives physicians one of the most precise tests available to guide treatment decisions and builds upon Abbott's 30-year legacy in hepatitis testing."
HBV genomes have been classified into eight genotypes (A-H). Detecting HBV genotypes is important in terms of both monitoring the disease and guiding treatment decisions. For example, genotype C, which is prevalent in Asia, is considered to be associated with more severe liver disease and development of hepatocellular carcinoma. In contrast, genotype B (also prevalent in the Asia region) has a better prognosis, is rarely associated with hepatocellular carcinoma and seems to have a better response to certain antiviral therapies compared with genotype C.
The Abbott RealTime HBV assay has been developed for use on the Abbott m2000 system, an automated instrument for DNA and RNA testing in molecular laboratories. The m2000 system is based on real-time polymerase chain reaction (PCR) technology and is designed to efficiently detect and measure life-threatening viruses and bacteria in patient serum or plasma samples in less than five hours, compared to other testing methods that may take up to two days. The RealTime HBV test is not intended as a screening test for HBV or as a diagnostic test for confirming the presence of HBV infection.
Abbott currently markets the m2000 system and a menu of tests in countries throughout the world as part of a strategic alliance with Celera. In Europe, the instrument's menu includes assays for HIV-1 viral load, HCV viral load, chlamydia, and a combination test for chlamydia and gonorrhea.
"We're very pleased that the menu for the m2000 system is expanding in Europe with the registration of the RealTime assay for monitoring hepatitis B viral load," said Kathy Ordonez, president, Celera. "The five tests now approved for sale in Europe on the m2000 system reinforce the system's breadth of menu as a competitive advantage."
About Hepatitis B
According to the World Health Organization, hepatitis B is a serious global public health problem, but preventable with safe and effective vaccines that have been available since 1982. Of the two billion people who have been infected with the hepatitis B virus, more than 350 million have chronic (lifelong) infections. These chronically infected persons are at high risk of death from cirrhosis of the liver and liver cancer, diseases that kill about one million people each year. Although the vaccine will not cure chronic hepatitis, it is 95 percent effective in preventing chronic infections from developing. The prevalence of HBV infection and the method of transmission vary greatly around the world. In countries with a high prevalence of chronic HBV infection, the most common route of infection is from mother to child at birth or from child to child during early childhood. In areas of low prevalence, the infection is usually acquired during adulthood through intravenous drug use or high-risk sexual activity.
About Applera Corporation and Celera
Applera Corporation consists of two operating groups: Celera and the Applied Biosystems groups. Celera is primarily a molecular diagnostics business that is using proprietary genomics and proteomics discovery platforms to identify and validate novel diagnostic markers, and is developing diagnostic products based on these markers as well as other known markers. Celera maintains a strategic alliance with Abbott for the development and commercialization of molecular, or nucleic acid-based, diagnostic products, and is also developing new diagnostic products outside of this alliance. Through its genomics and proteomics research efforts, Celera is also discovering and validating therapeutic targets, and has established and is seeking strategic partnerships to develop therapeutic products based on these discovered targets.
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 and develop new pharmaceuticals. Applied Biosystems' products also serve the needs of some markets outside of life science research, which is referred to as "applied markets," such as the fields of: human identity testing (forensic and paternity testing); biosecurity, which refers to products needed in response to the threat of biological terrorism and other malicious, accidental, and natural biological dangers; and quality and safety testing, for example in food and the environment. Applied Biosystems is headquartered in Foster City, Calif., and reported sales of over $1.9 billion during fiscal 2006. 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 is available at http://www.celera.com.
Applera Corporation's Forward-Looking Statements
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 and HCV assays 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.
About Abbott's Molecular Diagnostics Business
Abbott Molecular, a division of Abbott based in Des Plaines, Ill., is an emerging leader in molecular diagnostics -- the analysis of DNA, RNA and proteins at the molecular level. Abbott Molecular's instruments and tests provide physicians with critical information based on the early detection of pathogens and subtle, but key changes in patients' genes and chromosomes. They help physicians diagnose disease and infections earlier, select appropriate therapies and monitor disease progression. In addition to the m2000 and the RealTime tests for infectious diseases, Abbott Molecular's portfolio of products includes innovative genomic tests for chromosome changes associated with congenital disorders and cancer, including the PathVysion® HER-2 DNA Probe Kit, a test used to help select women with breast cancer who could benefit from Herceptin® therapy, and UroVysion(TM), which detects genetic changes in bladder cells for aiding in the diagnosis and monitoring of bladder cancer in patients with hematuria (blood in the urine) and for monitoring of bladder cancer recurrence.
About Abbott
Abbott 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 65,000 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.
Source: Abbott; Celera