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Nanosphere requests FDA approval for cardiac troponin I test

This article was originally published in Clinica

Executive Summary

Nanosphere has submitted a 510(k) application to the US FDA for its cardiac troponin I test. It is designed to provide "early and sensitive" diagnosis of myocardial infarction (MI), and to stratify patients with acute coronary syndromes. Troponin is an established cardiovascular biomarker which is elevated during acute MI. The current gold-standard for diagnosis is troponin plus ECG, but there is a time lag of around four hours between MI occurring and troponin levels rising. Therefore researchers have suggested combining it with other biomarkers such as copeptin, or using more sensitive cardiac troponin assays (www.clinica.co.uk, September 3 2009).

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