Healthcare Industry News: Herceptin
News Release - July 21, 2006
Abbott to Preview m2000(TM) Real-Time PCR Diagnostics System Designed to Provide Fast, Efficient Testing in the Molecular LabU.S. Premarket Approval Application Submitted for HIV-1 Viral Load Test for Use on the Automated System
DES PLAINES, Ill., July 21 (HSMN NewsFeed) -- Abbott Molecular will preview its new automated molecular diagnostics system, the m2000(TM), at the annual meeting of the American Association for Clinical Chemistry (AACC) in Chicago (July 23-27). The m2000 is based on real-time polymerase chain reaction (PCR) technology for detecting and monitoring infectious diseases and is designed to provide clinical laboratories a unique system that fully automates all of the complex and heavily manual steps often associated with molecular diagnostics.
The m2000 is pending 510(k) clearance with the U.S. Food and Drug Administration. Abbott Molecular has submitted a Premarket Approval Application in the United States for a viral load test for the human immunodeficiency virus (HIV-1) for use on the m2000 system.
Also in development for use on the m2000 system are tests for hepatitis C (HCV), hepatitis B (HBV), chlamydia (CT) and gonorrhea (NG). Tests for HIV-1, HCV and a combination test for CT/NG and have been launched in the European Union with CE Mark certification. The m2000 features an "open mode" testing capability, which will allow users to run any real-time PCR reagents with compatible components on it. Abbott Molecular will provide the m2000 system and its menu of tests as part of an alliance with Celera.
"The m2000 has been designed to help our customers deliver patient test results quickly and efficiently, with extremely accurate results," said Edward Michael, president, Abbott Molecular. "This innovative system represents our continued commitment to accelerate automation for the clinical molecular laboratory and improve the diagnosis, monitoring and care of patients with infectious diseases and other serious illnesses."
The m2000 system consists of two instruments: the Abbott m2000sp and the m2000rt. It links an automated sample preparation instrument (m2000sp) with an integrated real-time PCR amplification and detection instrument (m2000rt) via software to provide automation from sample extraction to the reporting of the final test result. The m2000 is designed to take much of the time and labor out of preparing samples for testing. Its robotic arm, for example, eliminates such steps as manual pipetting, reducing hands-on time required to prepare samples for DNA/RNA testing by as much as 75 percent.
PCR is a key technology in molecular diagnostics and life science research in which a segment of DNA or RNA is copied or "amplified" so that it can be more readily analyzed. It is often compared to the photocopying of nucleic acid (DNA or RNA).
Real-time PCR is a modification of standard PCR and provides greater accuracy in applications such as the quantification of viruses like HIV and hepatitis in human plasma. 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 or RNA 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 and is designed to provide increased productivity and reduced opportunity for human error, resulting in consistent and reproducible results.
About Abbott Molecular
Abbott Molecular, 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, allowing for earlier diagnosis, selection of appropriate therapies and monitoring of disease progression.
Abbott Molecular's portfolio of products also 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 metastatic 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 (NYSE: ABT ) 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.
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