Healthcare Industry News: Herceptin
News Release - January 8, 2007
Abbott m2000(TM) Molecular Diagnostic Instrument and Viral Load Tests for HIV-1 and HCV Approved in CanadaFirst HIV-1 Viral Load Assay Approved by Health Canada That Can Detect and Accurately Measure HIV-1 Group M Subtypes, Group O and Group N
MISSISSAUGA, Ontario, Jan. 8 (HSMN NewsFeed) -- Abbott (NYSE: ABT ) and Celera (NYSE: CRA ), an Applera Corporation business, announced today that Health Canada has approved the Abbott m2000(TM) automated molecular diagnostic instrument and the Abbott RealTime(TM) HIV-1 and hepatitis C virus (HCV) viral load tests for marketing in Canada.
The Abbott RealTime HIV-1 and HCV assays are intended for in vitro diagnostic use as an indicator of disease prognosis and an aid in the management of patients undergoing antiviral therapy. The assays are not intended to be used as screening tests for HIV-1 or HCV, or as diagnostic tests to confirm the presence of HIV-1 or HCV infection.
Both tests have been developed for use on the Abbott m2000 system, a fully automated instrument intended to improve DNA and RNA testing in molecular laboratories. The m2000 system is based on real-time polymerase chain reaction (PCR) technology and is designed to accurately 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.
Additional products in development for the Abbott m2000 system include assays for hepatitis B virus (HBV) and HCV genotyping.
About Viral Load Testing
The quantitative measurement of HIV and HCV levels in blood serum or plasma has greatly contributed to the understanding of the process by which viral infections lead to disease and has been shown to be an essential parameter in the prognosis and management of HIV and HCV infected individuals. Decisions regarding initiation or changes in antiviral therapy are guided by monitoring plasma HIV or HCV levels (viral load) and the patient's clinical condition. The goal of antiviral therapy is to reduce HIV or HCV in plasma to below detectable levels.
HIV-1 Viral Load
The Abbott RealTime HIV-1 assay is among the most sensitive viral load tests available today with a broad dynamic range, capable of measuring as few as 40 copies of HIV-1 RNA per milliliter of plasma and as high as 10 million copies of HIV-1 RNA per milliliter of plasma.
In addition, the Abbott test is the only HIV-1 viral load assay approved by Health Canada that can detect and accurately measure the three major groups of HIV-1 as well as non-B subtypes. HIV-1 can be divided into groups M (major), O (outlier) and N (new). The vast majority of isolates cluster in the M group. Distinct lineages within group M have also been identified, and these lineages are called strains or subtypes. These include subtype designations A, B, C, D, F, G, H, J and K. While HIV-1 subtype B continues to be the most common strain found in Canada, studies suggest that an increasing number of newly diagnosed patients may be infected with non-B subtype strains and various circulating recombinants, according to the Public Health Agency of Canada. The ability to detect and measure these subtypes in patients is an important factor in managing the disease and determining the most effective course of treatment.
HCV Viral Load
The Abbott RealTime HCV assay is also among the most sensitive viral load tests available today, capable of measuring as few as 12 IU (international units) of HCV RNA per milliliter and as high as 100 million IU of HCV RNA per milliliter.
"The reliability and precision of these tests across a broad dynamic range should help physicians be confident about assessing viral levels in their patients, enabling them to provide optimal treatment," said Timothy Stenzel, M.D., Ph.D., medical director, Abbott Molecular.
About the m2000
The m2000 system consists of two instruments: the Abbott m2000sp and the m2000rt. The system's sophisticated computer software links an instrument that automates the extraction, purification and preparation of DNA and RNA from patient samples (m2000sp) with a real-time PCR instrument that amplifies, detects and measures minute levels of infectious agents (m2000rt). The system automates a variety of manual processing steps, such as pipetting, helping to reduce the hands-on time required to prepare patient samples for DNA/RNA testing by as much as 75 percent.
"By automating all of the complex and heavily manual steps often associated with molecular testing, the m2000 system gives molecular laboratories the ability to prepare patient samples and deliver test results fast and efficiently," said Edward Michael, president, Abbott Molecular. "As a result, it is expected to help physicians improve medical care through earlier intervention and the ongoing monitoring of a patient's response to therapy."
"We're very pleased that the first m2000 assays have been registered in Canada," said Kathy Ordonez, president, Celera. "This represents a significant first step in our strategy to increase global sales for this important series of alliance products, which are already being sold throughout Europe and countries that recognize the CE certification across Asia and Africa."
The m2000 system and a menu of tests for HIV-1, HCV, Chlamydia trachomatis (CT) as well as a combination test for CT/Neisseria gonorrhoeae are available in the European Union with CE Mark certification. The instrument, in combination with a test for HIV-1, has been submitted for regulatory approval in the United States.
Abbott Molecular markets the m2000 system and a menu of tests throughout the world as part of a strategic alliance with Celera.
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, CA, 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 .
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. 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.
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 .
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.
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