Cardiac troponin (cTn), an indicator of heart tissue damage, has become an essential part of diagnosing myocardial infarction (MI) since testing for it was introduced in the 1990s. New “high sensitivity” (hs-cTn) assays are common in Europe and other parts of the world but not yet widely available. In November, the U.S. Food and Drug Administration (FDA) convened a day-long meeting to discuss the next stage in evaluating and introducing hs-cTn assays for clinical use in the U.S. A recent article in Clinical Laboratory News highlighted the results of the meeting.
Allan Jaffe, M.D., Consultant and Chair of Mayo Clinic’s Division of Clinical Core Laboratory Services, with a joint appointment in the Division of Cardiovascular Diseases, participated in the meeting.
When discussing clinical trials of point-of-care hs-cTn assays, one member of the meeting commented that all clinicians do not need to use the same assay because some clinicians rely on cTn results to rule-in MI patients, but others might use them more to rule out MI in order to send patients home safely without further workup.
However, Dr. Jaffe noted that many institutions, especially those in rural areas, need to use the same assay for both tasks. “It often will be used as a solitary device,” he said, so devices need to be able to handle both kinds of demands.
According to the article, the FDA plans to take comments made by panelists and audience members as a starting point for guidelines for troponin-assay manufacturers seeking clearance.