Beckman Coulter Receives FDA Clearance to Market New Cardiac Test; 12-Minute Test One of the Fastest Available.

Business Editors & Medical/Science Writers

FULLERTON, Calif.--(BW HealthWire)--June 8, 2001

Beckman Coulter, Inc. (NYSE:BEC) announced Friday it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market a new test to aid in the diagnosis and treatment of myocardial infarction -- or heart attack -- and cardiac muscle damage.

The new Access(R) AccuTnI(TM) test accurately and reliably measures levels of cardiac troponin I, a protein released into the bloodstream following a heart attack.

Available on Beckman Coulter's Access immunoassay systems, Access AccuTnI is intended for use by hospitals in routine and emergency situations and can be run in about 12 minutes, making it one of the fastest cardiac tests on the market. Access AccuTnI is one of 36 tests available in the United States on the Access platform, which performs other cardiac tests as well as tests for cancer, anemia, thyroid, infectious disease and fertility.

"Access AccuTnI is based on nearly a decade of advances in troponin research and represents a significant improvement in troponin I testing," said Russ Bell, vice president-director of Beckman Coulter's immunodiagnostics development center. "The test has been formulated using today's knowledge of troponin I and critical information that was not available when troponin I tests were first developed. Because many older tests are still using formulations based on assumptions made nearly 10 years ago, they are not as sensitive or as reliable as Access AccuTnI."

Added Denise Uettwiller-Geiger, Ph.D., administrative director and clinical chemist at Port Jefferson, N.Y.-based John T. Mather Memorial Hospital, one of five independent research sites that studied the clinical effectiveness of the new test, "During our clinical trials, Access AccuTnI was very effective in distinguishing a healthy person, who should not have detectable levels of troponin, from someone who has troponin and therefore may have some degree of cardiac muscle damage. The test demonstrated excellent sensitivity, detecting troponin I at very low levels."

Clinical trials also indicated that Access AccuTnI has virtually no response to substances sometimes found in the blood that can interfere with testing and lead to false-positive results.

Furthermore, the test is effective as an aid in diagnosing heart attacks in "late-presenting" patients -- patients who may have experienced a heart attack several days prior to seeking medical treatment. According to Linda Rogers, Ph.D., Beckman Coulter principal technical marketing consultant, the test's effectiveness in this regard is a result of special antibodies used to detect troponin molecules.

"While cardiac troponin levels remain elevated for several days following a heart attack, the molecules disintegrate rapidly," said Rogers. "Our test includes antibodies that target the stable region of the troponin molecule, even if it is in a degraded state. Other troponin tests detect only intact molecules, so they may have difficulty detecting troponin levels if the molecules are in a degraded state. Consequently, some heart attacks can be missed."

In the United States, more than 6 million people have a heart attack or report chest pain every year, while more than 300,000 Americans die of a heart attack annually, according to the American Heart Association.

Recently, a number of scientific organizations have offered new guidelines that call for the standardization of cardiac testing and the use of cardiac troponin tests to improve diagnosis of heart attacks. These organizations include the National Academy of Clinical Biochemistry, American College of Cardiology and European Society of Cardiology.

As more physicians incorporate these guidelines in their clinical practice, the number of heart attacks correctly diagnosed is expected to increase. And by correctly diagnosing more heart attacks using troponin tests such as Access AccuTnI, physicians will be able to administer life-saving treatments sooner and improve the chances of patient survival.

Beckman Coulter, headquartered in Fullerton, Calif., is a leading provider of instrument systems and complementary products that simplify and automate processes in life science and clinical laboratories. The company's products are used throughout the world in all phases of the battle against disease, from pioneering medical research and drug discovery to diagnostic testing that aids in patient treatment. Annual sales for the company totaled $1.89 billion in 2000, with approximately half of this amount generated outside the United States.