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Nanosphere Submits Cardiac Test to FDA

NEW YORK (GenomeWeb News) – Nanosphere today said that it has submitted a 510(k) application with the US Food and Drug Administration for its cardiac troponin I test.

The firm said that the test is used to provide early diagnosis of myocardial infarction and risk stratification for acute coronary syndromes. The test runs on the firm's Verigene molecular diagnostics platform.

"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," Nanosphere President and CEO William Moffitt said in a statement.

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