Nanosphere Inc. (NSPH) said that it submitted a 510(k) application to the FDA for its cardiac troponin I test that the company believes will provide early and sensitive diagnosis of myocardial infarction and risk stratification for acute coronary syndromes.
The company noted that 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.
The company added that it is looking forward to complete the regulatory process and bring this assay to market.
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