Roche Diagnostics' Next Generation Automated PCR System, the COBAS TaqMan Analyzer, Now Available for Commercial Use.

Business Editors and Health/Medical Writers

PLEASANTON, Calif.--(BW HealthWire)--April 30, 2002

Following 510(k) clearance from the U.S. Food and Drug Administration (FDA) earlier this year, Roche Molecular Diagnostics is pleased to announce that its next generation automated PCR system, the COBAS TaqMan(TM) Analyzer, is now commercially available and has already been adopted by several leading clinical laboratory networks in the U.S.

The COBAS TaqMan Analyzer is designed to automate in vitro diagnostic assays utilizing real time Polymerase Chain Reaction (PCR) technology for the detection and quantification of infectious agents that cause disease. By first using the Roche COBAS AmpliPrep(TM) System to prepare PCR specimens and then employing the COBAS TaqMan System, which automates the amplification, detection and quantitation of DNA or RNA, PCR analysis is totally automated.

TaqMan Based on Patented Roche Technology

In November 1999 and February 2001, Roche was issued two important patents from the U.S. Patent and Trademark Office relating to enabling the simultaneous detection and quantitation of nucleic acid amplification reactions, such as PCR, through dye-based, probeless detection methods. In early amplification processes, the DNA or RNA in a sample was amplified first and then detected in a separate step. Roche's patented process combines the two steps by including fluorescent dyes in the reaction to provide for real-time monitoring of the amplified product as it is produced (simultaneous amplification and detection). This "real time" PCR method will dramatically reduce the time and steps needed to obtain qualitative and quantitative test results.

These processes, also known as "Kinetic PCR," offer significant advantages to the diagnostic, molecular biology or microbiology laboratory in terms of efficiency and productivity. Along with the increase in speed, real-time quantitation PCR reduces the threat of contamination, as the entire test takes place in a sealed tube. In addition, Kinetic PCR-based quantitation methods provide an increase in dynamic range, which makes the process more useful for a variety of applications. The elimination of a separate detection step significantly reduces hands-on time, a major advantage for laboratories attempting to control costs while increasing output.

"Providing our clinical laboratory customers with total PCR automation has been a major goal for us as we continue our technology development efforts," says Heiner Dreismann, Ph.D., head of Roche Molecular Diagnostics. "We're excited that three U.S. national reference laboratories are already using the COBAS TaqMan system and we're hopeful that others will adopt this system shortly, too," he adds.

Roche's expertise and experience in PCR

Roche's cornerstone PCR system, the COBAS AMPLICOR(TM) Analyzer, launched in Europe in 1995 and in the U.S. in 1997, was the first system to automate both the amplification and detection steps of the PCR testing process by combining five instruments into one (thermal cycler, automatic pipettor, incubator, washer and reader). There are now close to 4000 COBAS AMPLICOR systems in clinical settings worldwide. The system has a broad test menu with the ability to test for Chlamydia trachomatis (CT), Neiserria gonorrhea (NG), Mycobacterium tuberculosis(a) (Mtb), cytomegalovirus(a) (CMV), hepatitis B virus(a) (HBV), hepatitis C virus (HCV) and HIV(a).

Roche's automated instrumentation for the preparation of nucleic acid for PCR, the COBAS AmpliPrep System, has an introductory menu for the detection and quantitation of HCV(a) and the quantitation of HIV(a).

About Roche and Roche Molecular Diagnostics

Headquartered in Basel, Switzerland, Roche is one of the world's leading research-oriented healthcare groups in the fields of pharmaceuticals, diagnostics and vitamins. Roche's products and services address prevention, diagnosis and treatment of diseases, thus enabling well-being and quality of life. Roche's Diagnostics Division, the world leader in in vitro diagnostics with a uniquely broad product portfolio, supplies a wide array of innovative testing products and services to researchers, physicians, patients, hospitals and laboratories worldwide. Roche Molecular Diagnostics, a business area of Roche Diagnostics, has made the polymerase chain reaction (PCR) the leading nucleic acid amplification technology (NAT) in the world. PCR technology allows minute amounts of genetic material to be amplified into billions of copies in just a few hours, thereby facilitating detection of the DNA or RNA of pathogenic organisms even before antibodies to these organisms are formed. Roche Diagnostics' website is located at www.roche-diagnostics.com.

Note (a): Available in the US for research use only