Roche Diagnostics Introduces Cyclosporine Assay for the COBAS Integra® 400 Plus Chemistry System

INDIANAPOLIS, IN (March 13, 2002) -Today Roche Diagnostics announces the availability of the new COBAS Integra Cyclosporine immunoassay for the quantitative determination of cyclosporine A (CsA) in human whole blood as an aid in the management of cyclosporine therapy in kidney, heart, and liver transplant patients. This new assay enhances patient care with its high specificity, enhanced sensitivity, and rapid turnaround time.

CsA is one of the most common immunosuppressants used to prevent graft rejection in kidney, heart, and liver transplant patients. Because patient response and dosage requirements are highly variable, monitoring CsA levels is essential for improving patient outcome and ensuring cost-effective patient care. The new COBAS Integra assay monitors CsA levels so they can be maintained within an optimal range that minimizes the risk of rejection and drug-induced cytotoxicity.

The COBAS Integra CsA assay uses the enzyme multiplied immunoassay technique (EMIT®) technology, which was recognized by the Lake Louise Consensus Conference on cyclosporine monitoring in organ transplantation as the assay with the specificity required for the greatest monitoring accuracy. EMIT technology offers more parent drug specificity than other immunoassays, including current RIA and FPIA, and has excellent correlation with the HPLC reference method.

Complementing the high specificity of the assay, the enhanced sensitivity of 22 ng/mL enables the COBAS Integra CsA assay to detect low concentrations of CsA, which is an important factor in the management of low-dose and combination immunosuppressive therapies. Additionally, the rapid turnaround time of 20 minutes to first result allows for adjustments to be made to the patient's therapy before leaving the clinic.

This CsA assay is an addition to the already broad COBAS Integra 400 plus menu, which offers a full line of clinical chemistry assays often recommended in conjunction with CsA monitoring, as well as whole blood hemoglobin A1c, direct HDL and LDL. Along with helping laboratories maximize time and cost efficiency through workstation consolidation, the COBAS Integra 400 plus system offers a standardized, easy-to-use clinical chemistry testing platform.

Headquartered in Basel, Switzerland, Roche is one of the world's leading research-oriented health care groups in the fields of pharmaceuticals, diagnostics, and vitamins. Roche's products and services address prevention, diagnosis, and treatment of diseases, thus enhancing 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 Diagnostics Corporation, based in Indianapolis, is the North American headquarters for the diagnostics business of the company. Roche's website is located at www.roche-diagnostics.com.

COBAS INTEGRA is a trademark of a member of the Roche Group. EMIT is a trademark of Syva Company.