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Beckman Coulter Gets FDA Clearance Of New Access AccuTnI+3 Troponin I Assay

Beckman Coulter, Inc., a subsidiary of Danaher Corp. (DHR) Wednesday said the U.S. Food and Drug Administration, or FDA, has granted clearance of its new Access AccuTnI+3 troponin I assay for use on its Access 2 immunoassay system.

"Clinicians have depended on Beckman Coulter's troponin I test for over 12 years and the new AccuTnI+3 assay has the proven performance to continue providing dependability to laboratories supporting emergency care," said Arnd Kaldowski, president, Beckman Coulter Diagnostics.

In October 2010, the FDA issued guidance to all manufacturers of troponin assays in an effort to modernize the performance evaluation and regulatory review of these critical tests.

In accordance with the FDA's new requirements, Beckman Coulter conducted a large multicenter prospective clinical trial that enrolled over 1,900 subjects. The data from the trial showed that the assay delivers the precision, clinical sensitivity and clinical specificity necessary to assist physicians with the diagnosis of MI.

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