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Cardiac Troponin Assays Will Get US FDA Attention At November Workshop

Troponin assays are routine tools for diagnosing heart attacks, but there have been challenges on the regulatory front, as testing standards evolve and technology rapidly improves. The agency has called a public meeting for late November to discuss scientific and regulatory challenges for troponin assays and more efficient development strategies.

US FDA is holding a public workshop in November to discuss challenges and best practices with the development of cardiac troponin assays. The Nov. 28 meeting at the agency's Silver Spring, Md., headquarters is intended to "facilitate device development and to discuss scientific and regulatory challenges associated with the analytical and clinical validation methods for troponin assay devices," FDA said in a federal register notice announcing the meeting.

Troponin is a protein which if found in high amounts in the blood could signal heart muscle death and predict a heart attack. Assays for troponin are routinely used in...

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