Siemens gets FDA clearance for high-sensitivity troponin assays

Siemens Healthineers received FDA clearance for two high-sensitivity troponin assays, which measure levels of the protein released into the bloodstream during a heart attack. They will now be made available in the U.S.

The company said the assays can detect lower levels of troponin in serum or plasma compared to traditional assays, with improved precision at the 99th percentile, as well as detect smaller changes in patients’ levels over time.

The troponin I assays were cleared for use with the Siemens Healthineers’ Atellica IM and ADVIA Centaur XP/XPT in vitro laboratory analyzers. Siemens Healthineers is the separately managed healthcare business of Siemens AG.

Complaints of chest pain cause more than 8 million emergency room visits per year, the company said, though only about 5 percent end up being related to myocardial infarctions.

Within 60 minutes of a heart attack, the presence of troponin in the bloodstream specifically indicates damage to the heart muscle. By measuring slight changes over time, ER physicians can more effectively triage life-threatening conditions and assign treatments or rule out and discharge patients who do not need to be in the hospital.

The assays have been available in Europe since May 2017, and meet current European Society of Cardiology guideline recommendations, the company said at the time.

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