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    FDA's Workshop on Troponin Assays Approval Fosters Agreement, Debate

    This article discusses a recent FDA workshop held for troponin assays, tests designed most commonly to detect the release of cardiac troponin following Acute Myocardial Infarction (AMI). The authors review the history, uses and issues associated with using troponin - a three protein complex, released rapidly into the blood after myocardial injury - and innovative medical devices to detect troponin levels, as an assay to aid in the diagnosis of an AMI event. Regulatory pro...
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    Impact of Clinical Utility Requirements on In Vitro Diagnostic Assays

    The term "clinical utility" has come into increasingly common usage as healthcare stakeholders direct greater attention to the determination and establishment of the value of healthcare services, interventions and technologies. The meaning differs somewhat among the various stakeholders depending on their roles and interests. For example, one Medicare contractor (Palmetto) describes its requirement for evidence of clinical utility as "demonstrates change in physician trea...