Behring Diagnostics Receives Approval to Market the Emit 2000 Cyclosporine Specific Assay in the United States.

FRANKFURT, Germany and SAN JOSE, Calif.--(HealthWire)--Oct 29, 1996--Behring Diagnostics, a division of Hoechst, today announced that it has received U.S. Food and Drug Administration approval to market the Emit(R) 2000 Cyclosporine Specific Assay. The Emit 2000 Cyclosporine Specific Assay is indicated for in vitro diagnostic use for the quantitative analysis of cyclosporine in human whole blood as an aid in the management of cyclosporine therapy in kidney, heart, and liver transplant patients. With the product's introduction in the United States, the Emit 2000 Cyclosporine Specific Assay is now available worldwide.

Cyclosporine is the number one prescribed immunosuppressive drug worldwide. It is used to control rejection in transplant patients caused by antigenic differences remaining after tissue-typing and donor-recipient matching. Since these drugs reduce immunologic reactions and also the metabolism of rapidly dividing cells, overwhelming infection is the leading cause of death in transplant patients. Carefully selected and administered immunosuppressive treatments have been primarily responsible for the present success of clinical transplantation.

Transplant centers have found blood concentration monitoring of cyclosporine to be an essential component of patient management. Of importance to blood-concentration analysis are the type of assay used, the transplanted organ, and other immunosuppressant agents being administered. Blood concentration monitoring assists in the clinical evaluation of rejection and toxicity, dose adjustments, and assessment of compliance.

"The key to achieving the maximum clinical benefit of cyclosporine is effective monitoring of blood levels to achieve the target dose administered to patients," said Jean Luc Devleeschauwer, Head of Marketing, Syva/Plasma Proteins, Global Marketing Organization, Behring Diagnostics. "Since its availability, cyclosporine has saved thousands of lives through organ survival. We believe that the Emit 2000 Cyclosporine Specific Assay, because of its very high specificity and sensitivity, has been a significant contributing factor to improved monitoring for transplant patients."

In a consensus report on cyclosporine published in Therapeutic Drug Monitoring (vol. 17, No. 6, 1995), the researchers found that the Emit Cyclosporine Specific Assay showed the highest specificity and calibration accuracy for monitoring cyclosporine concentrations compared with the two other immunoassays used as comparisons for this report (INCSTAR, RIA, Abbott, mFPIA). The Emit assay best fulfilled the proposed performance criteria for accuracy. The consensus document was based on a meeting with more than 15 experts participating in a working session on immunosuppressive therapy held as part of the International Immunosuppressive Consensus Conference in Lake Louise, Canada, to review recommendations and guidelines previously established for the monitoring of immunosuppressive drugs.

Whole blood, rather than plasma, is the matrix of choice for the measurement of cyclosporine since the drug is rapidly distributed into the red blood cells.

The Emit 2000 Cyclosporine Specific Assay employs a homogeneous enzyme immunoassay technique for the analysis of cyclosporine in whole blood. The assay contains mouse monoclonal antibodies with a high specificity for cyclosporine. Before testing with the assay, samples, calibrators, and controls are pretreated with methanol. Methanol lyses the cells, solubilizes the cyclosporine, and precipitates most of the blood proteins. The samples are centrifuged, and an aliquot of the resulting supernatant containing cyclosporine is diluted with Emit(R) 2000 Cyclosporine Specific Diluent. This solution is then assayed using Reagents A and B on Roche's COBAS MIRA, COBAS MIRA S, or COBAS MIRA Plus chemistry system.

Behring Diagnostics continues to be a major supplier of products to monitor immunosuppression therapies. Outside the United States, Behring Diagnostics has marketed the Emit 2000 Cyclosporine Specific Assay for several years. The worldwide immunosuppressant market is estimated to be $50 million. In the United States, the immunosuppressive market is estimated to be approximately $25 million.

Behring Diagnostics, a division of Hoechst, with headquarters in Frankfurt, Germany, manufactures and markets in vitro diagnostic systems used by healthcare professionals in hospitals and laboratories throughout the world. The division has five business lines: plasma proteins, coagulation and microbiology, based in Marburg, Germany; the OPUS(R) business line, located in Westwood, Massachusetts; and the Syva(R) business line, based in San Jose, California. Behring Diagnostics acquired the former Syva Company in 1995. In 1995, Behring Diagnostics had consolidated net sales of DM 1.027 billion. The division employs approximately 3,000 worldwide. -0- Emit, OPUS and Syva are registered trademarks of Behringwerke AG.

CONTACT: Jean Luc Devleeschauwer,

Behring Diagnostics,

ph: [phone]; fx: [phone];

voicemail in the U.S., [phone], box 8033

or

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Merrie Deitch, Burns McClellan

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