Trade News

Basel, May 28, 2001

New Roche Instrument Enables Complete PCR Automation for clinical diagnostic testing

Pleasanton, California, May 28, 2001 - Roche Molecular Systems, Inc. today announced the launch of its new COBAS AmpliPrep™ System in Europe. The COBAS AmpliPrep System automates the entire sample preparation process of nucleic acid extraction for PCR analysis on the COBAS AMPLICOR Analyzer, dramatically reducing hands-on time and enabling highly skilled personnel to use their expertise more cost-effectively.

With traditional manual sample preparation, highly skilled lab personnel devote considerable amounts of time to numerous, repetitive tasks, particularly for sample preparation. According to independent studies, as much as 70% of the cost of PCR testing was attributable to sample preparation tasks - an obvious difficulty in the increasingly competitive, cost-conscious laboratory environment.

An automated solution can help laboratories reduce costs and improve productivity while potentially reducing the chance of technique-dependent error. Samples prepared by the COBAS AmpliPrep can be transferred directly to the COBAS AMPLICOR Analyzer, which automates amplification, detection and result calculation, providing a complete standardized solution for rapid routine PCR testing.

The introductory assay menu includes qualitative and quantitative assays for HCV and a quantitative assay for HIV-1. Roche's complete PCR automation system will be on view from May 26-31 at EUROMEDLAB 2001, the 14th IFCC-FESCC European Congress of Clinical Chemistry and Laboratory Medicine, in Prague.

The COBAS AmpliPrep System virtually eliminates the labor-intensive steps involved in preparing a sample for PCR analysis. The technologist simply loads samples, reagents and reaction vessels onto the system, and patient orders can be manually entered via the user-friendly AMPLILINK software or downloaded from the LIS (Laboratory Information System). The system is flexible; it can accommodate up to 72 samples and runs up to four different test protocols simultaneously. System throughput of 20-24 samples per hour results in greater productivity - approximately 144 samples can be performed per shift.

The COBAS AmpliPrep System incorporates a wide range of innovative features to minimize errors sometimes associated with manual sample preparation. Reagents are sealed in bar-coded, ready-to-use, patented-design cassettes for fast and accurate reagent data entry and increased reagent stability. Roche AMPLILINK™ software positively identifies and tracks the bar-coded patient samples from sample input on the COBAS AmpliPrep System through analysis on the COBAS AMPLICOR Analyzer. The Sample Processing Unit (SPU) is a single-use reaction vessel designed to prevent cross contamination. A Pipetting Integrity Check ensures the correct aspiration and dispensing of samples and reagents, thereby minimizing the risk of incorrect results due to pipetting of insufficient volumes. In addition, an automatic clot detection step reduces the risk of an incorrect result due to a clot or particles in the sample. The AmpliPrep's internal control/quantitative standard monitors inhibition and target recovery throughout the entire process. AmpErase® (uracil-N-glycosylase, UNG) removes potential contaminants by the selective destruction of previously amplified material.

Heiner Dreismann, President of Roche Molecular Systems, noted, "We are proud to introduce this vital link in the automation chain. The new COBAS AmpliPrep addresses the automation needs of the clinical laboratories and complements perfectly the COBAS AMPLICOR Analyzer, which has been reliably performing in laboratories worldwide for more than five years. Roche's development of standardized olutions for routine PCR testing, combined with an emphasis on reliability, productivity and results integrity demonstrates the Company's commitment to its laboratory customers and its expertise in nucleic acid testing technologies."

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 innovative products and services address needs for the prevention, diagnosis and treatment of disease, thus enhancing people's well being and quality of life. Roche's Diagnostics Division supplies a wide array of innovative testing products and services to physicians, patients, hospitals and laboratories worldwide. Roche Molecular Diagnostics, a business unit of Roche Diagnostics, has made the polymerase chain reaction (PCR) the leading DNA probe technology 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. PCR nucleic acid amplification-based test kits are marketed under the trade name AMPLICOR®.