Behring Diagnostics' Cardiac Marker Assay Receives US Marketing Clearance; New Cardiac Troponin I Assay will Provide Results in 22 Minutes.

SAN JOSE, Calif. and FRANKFURT, Germany--(HealthWire)--Feb. 27, 1996-- Behring Diagnostics, a division of Hoechst, today announced the receipt of U.S. Food and Drug Administration marketing clearance for its cardiac troponin I assay. The OPUS(R) Troponin I assay is intended for use on the OPUS(R), OPUS(R) Plus and OPUS(R) Magnum immunoassay systems, as an aid in the diagnosis of acute myocardial infarction (AMI). To date, studies have shown troponin I to be more specific to myocardial infarction than other markers based upon the lack of skeletal or renal interference. This includes troponin T, which studies suggest can be elevated by other medical conditions.

Behring Diagnostics' OPUS instrument line provides true random access, so patient samples can be run as soon as a lab receives them. This differentiates the Behring OPUS cardiac panel from cardiac assays run on other instruments, which run samples in batches, requiring labs to hold samples until a sufficient number of tests can be run simultaneously. The OPUS cardiac panel provides physicians with the rapid results needed for effective heart attack treatment.

When a heart attack occurs, blood flow and oxygen supply are disrupted to part of the heart muscle, killing healthy cells. When these cells die, cardiac troponin I is released into healthy tissue and the bloodstream. By measuring cardiac troponin I and levels of other cardiac markers present in an individual's blood serum, a physician can determine whether a heart attack has occurred. Cardiac troponin I is present in serum four to six hours after onset of acute myocardial infarction, and it is only present following heart muscle damage. Cardiac troponin I remains elevated for up to seven days.

With the introduction of the new cardiac troponin I assay on the OPUS, OPUS Plus and OPUS Magnum instruments, Behring Diagnostics now offers a complete panel of cardiac marker tests, including myoglobin, CK-MB, and total CK. Results from all tests, plus a calculated relative index of CK-MB to total CK, are available in 22 minutes, providing the most complete information possible to assist in the management of patients during the critical period immediately following AMI. The OPUS cardiac marker assays offer high specificity and sensitivity, good precision, and reproducibility. The OPUS systems also offer thyroid, fertility, therapeutic drug monitoring and serology testing.

"Behring Diagnostics' OPUS Troponin I assay is the newest tool available to physicians for the detection of AMI," stated Prof. Uwe Bicker, president of Behring Diagnostics. "This exciting new product offers a clear advantage over many current diagnostics. It is faster, providing results in 22 minutes, more accurate and extremely easy to use. As a result, patients can receive the most appropriate care more quickly."

In the United States each year, 700,000 people are hospitalized due to AMI and an estimated 500,000 people die. Each year, approximately 75,000 people are misdiagnosed and not admitted to the hospital even though they present to the emergency room with classic heart attack symptoms. More specific and accurate diagnosis is necessary for patient well-being and to reduce overall costs associated with malpractice suits as well as unnecessary hospitalizations.

Behring Diagnostics, a division of Hoechst, with headquarters in Frankfurt, Germany, is an important competitor in worldwide immunodiagnostics, serum protein analysis, and coagulation. In 1994, the former Syva Co. posted worldwide sales of US$ 204 million and Behring Diagnostics posted worldwide sales of US$ 502 million (DM 814 million). The division has five business lines: the OPUS(R) business line, located in Westwood, Massachusetts; the Syva(R) business line, based in San Jose, California; and plasma proteins, coagulation and microbiology/infectious diseases, three further business lines, based in Marburg, Germany. Behring Diagnostics employs approximately 3,200 worldwide. -0- OPUS and Syva are registered trademarks of Behringwerke AG.

CONTACT: David Kuhn, Behring Diagnostics Inc.

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Ram Vairavan, Behring Diagnostics Inc.

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