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Nanosphere Files 510(K) Application To FDA For Verigene Cardiac Troponin I Assay

Nanosphere, Inc. (Nanosphere), a molecular diagnostics company, has submitted a 510(k) application to the US Food & Drug Administration (FDA) for its cardiac troponin I test.

The company believes that the test will provide early and sensitive diagnosis of myocardial infarction and risk stratification for acute coronary syndromes

William Moffitt, president and chief executive officer of Nanosphere, said: “We are pleased to submit this application and look forward to completing the regulatory process and bringing this important assay to market.

“There is growing evidence that early detection of cardiac troponin using sensitive assays is a critical test to aid in the diagnosis and treatment of myocardial infarction and in the risk stratification of patients with acute coronary syndrome,” he added.