Beckman troponin assay delays
This article was originally published in The Gray Sheet
Executive Summary
Beckman Coulter plans to submit two 510(k)s in the first half of 2011 for its embattled cardiac troponin assay after completing prospective clinical trials to support the submissions, the firm disclosed in a May 14 Securities and Exchange Commission filing. Last month, Beckman removed from the U.S. market its AccuTn1 troponin kits used on its Unicel DxI platform and restricted distribution of the kits for use on its Access platform after FDA identified modifications the firm had made to the assay without proper clearance (1"The Gray Sheet" April 19, 2010). "The timing of the re-submission is worse than expected, extending headwinds into 2011," writes David Lewis, a Morgan Stanley analyst, in a May 14 report
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