DES PLAINES, Ill. and ROCKVILLE, Md., May 11 /PRNewswire-FirstCall/ -- Abbott and Celera , an Applera Corporation business, announced today that Abbott has received U.S. Food and Drug Administration (FDA) approval to market the Abbott RealTime HIV-1 viral load test for use on the company's m2000(TM) automated instrument system.
The Abbott RealTime HIV-1 assay, for use on the new m2000 system, is designed to detect and precisely measure levels of the human immunodeficiency virus (HIV) circulating in a patient's blood (viral load), including the three major groups of HIV-1 as well as non-B subtypes. The test is intended for use as a marker of disease prognosis and an aid in assessing viral response to antiretroviral treatment.
"As the viral diversity of HIV-1 continues to increase, the need for highly sensitive tests to monitor patient response to antiviral therapies becomes even more important," said John Robinson, Ph.D., senior director, research and development, Abbott Molecular. "The reliability and precision of the Abbott RealTime HIV-1 test on the m2000 system for detecting HIV-1 subtypes across a broad dynamic range should help physicians be confident about assessing viral levels in their patients, enabling them to provide optimal treatment."
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. They include subtype designations A through G. While HIV-1 subtype B continues to be the most common strain found in the United States, studies suggest that an increasing number of newly diagnosed patients are infected with non-B subtype viruses and various circulating recombinants as a result of the influx of immigrants from countries where variant strains of HIV are more common. In a recent study published in the Journal of Medical Virology(1) examining the impact of this phenomenon on Minneapolis-based Hennepin County Medical Center, the predominant HIV subtypes identified by the hospital in African-born patients were subtype C (40 percent), followed by A (20-25 percent), D (10 percent) and G(3-5 percent).
Another recent study by the Centers of Disease Control and Prevention involving more than 3,000 HIV patients in the United States found that 5.1 percent of those patients were infected with HIV-1 non-B subtypes.(2)
"The ability to detect and measure each of these genetic variations of the virus is an important factor in managing the disease on a worldwide basis and determining the most effective course of treatment for patients," said Timothy Stenzel, M.D., Ph.D., medical director, Abbott Molecular.
The RealTime HIV-1 test 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 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 C virus (HCV), hepatitis B virus (HBV), HCV genotyping, chlamydia and gonorrhea. Abbott markets the m2000 system and a menu of tests throughout the world as part of a strategic alliance with Celera.
"We're very pleased that Abbott, through its alliance with Celera, has secured FDA approval on a real-time viral load assay for HIV," said Kathy Ordonez, president, Celera. "Today, more than 2 million HIV viral load tests are performed annually in the United States, and we believe both the Abbott RealTime HIV assay and the m2000 system offer substantial productivity and performance advantages to customers performing these tests."
About the Abbott RealTime HIV-1 Viral Load Test
The Abbott RealTime HIV-1 assay, for use on the m2000 system, is among the most sensitive viral load tests available today, with a broad dynamic range, capable of quantitating HIV-1 in plasma down to as few as 40 RNA molecules per milliliter (mL) and up to as many as 10 million molecules per mL. The Abbott RealTime HIV-1 assay is intended for use in conjunction with clinical presentation and other laboratory markers as an indicator of disease prognosis and for use as an aid in assessing viral response to antiretroviral treatment as measured by changes in plasma HIV-1 RNA levels. This assay is not intended to be used as a donor-screening test for HIV-1 or as a diagnostic test to confirm the presence of HIV-1 infection.
About the Abbott m2000
The Abbott 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, 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 Scott Safar, senior director, systems development and support, Abbott Molecular. "We believe the ease of use and sample tracking features of the instrument have taken automation to another level for molecular laboratories."
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 as CE-marked products.
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/.
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.
Abbott Molecular's portfolio of products includes innovative genomic tests for chromosome changes associated with congenital disorders and cancer, including the PathVysion(R) HER-2 DNA Probe Kit, a test used to help select women with breast cancer who could benefit from Herceptin(R) therapy, and UroVysionTM, which detects genetic changes in bladder cells for aiding in the diagnosis of bladder cancer in patients with hematuria (blood in the urine) and for monitoring 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/.
(1) Journal of Molecular Virology, Cartwright, 2006
(2) Abstract of the 14th Conference on Retroviruses and Opportunistic
Infections, Mahle K, Bodnar U, et al., 2007
