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US FDA Willing And Ready To Approve Novel Cardiac Troponin Assays

Executive Summary

Rumors that FDA has raised the bar too high for clearing cardiac troponin assays to predict myocardial infarction "are not true," a device center reviewer said at an agency workshop. FDA is open to novel tests and wants industry to give it direction on clinically meaningful cut-off levels of troponin for assays. Also, FDA issued a safety alert on consumer overuse of Biotin (Vitamin B7) for aesthetic purposes, which can interfere with the results of the assays.


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