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US FDA Willing And Ready To Approve Novel Cardiac Troponin Assays

 
• By Sue Darcey

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.

US FDA wants to work with all stakeholders and developers of cardiac troponin assays to increase the availability of such tests that work, according to agency reviewer Paula Capisino. Capisino, from FDA's division of toxicology and chemistry, in the Office of In Vitro Diagnostics and Radiological Health, spoke at a Nov. 28 FDA workshop on regulatory challenges surrounding the tests.

The agency offered its perspective on troponin clinical trials at the Silver Spring, Md

Troponin is a protein in blood, which at high levels can point to heart muscle death, predicting myocardial infarction

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