Troponin Assay Questions?

Communication and questions were the theme on November 28 at FDA’s Public Workshop on Troponin Assays — all about the opportunities and quandaries associated with high sensitivity and not so high negative predictive value. Consistent with this, slide decks were short and most of the time was spent in five different panel discussions. Below is a list of topics covered and a few notable points from each. Also, here’s a link an FDA page with recorded proceedings listed in sections – Part 1 through Part 4 – under Webcast Archive and Slides.

We’ll be watching for next statements and next steps from FDA, and we’re ready to work with clients who have pending matters in each of these areas.

Cut-Off Determination/Reference Interval Studies

  • Which subjects to enroll
  • How to analyze the data
  • What to do with outliers

Clinical Trial Design

  • Precision around each assay’s unique cut-off
  • Prognosis claims
  • Rapid rule out of MI
  • Informed consent challenges
  • Excluded subjects
  • Missing samples

Pre-Analytical and Analytical Considerations for Clinical Trials

  • Specimen stability
  • Tube type
  • Detection limits
  • Lab-to-lab and analyzer differences
  • Biotin interference

Clinical Trials for Point of Care Devices

  • Sample matrix performance differences – whole blood vs plasma
  • Fresh vs transported samples

Use of Existing Clinical Data to Support Claims

Beaufort, a leading diagnostic CRO and Regulatory consultancy, is experienced in assisting clients with Troponin assay goals. We work with both clients and sponsors in developing assays and managing every stage of your clinical trial.  Contact us to learn more about how we can support your Troponin and other clinical, regulatory, quality and staffing needs.


Lucy Gibney, MD, is Medical Director at Beaufort where she provides clients with a breadth of experience in medical, scientific and clinical leadership. Lucy advises operations staff in all aspects of medical management of clinical trials, while serving as a medical expert during the project delivery lifecycle.

Date posted: December 13, 2017

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