Siemens gets FDA Clearance for Troponin Assay

July 27, 2018  Source: FierceBiotech 242

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Siemens Health received US-FDA (US-Food and Drug Administration) clearance for two highly sensitive troponin assays, which detect protein levels released into the bloodstream during a heart attack allowing them to be made available in the U.S.

Siemens Health confirmed that these two assays can detect lower levels of troponin in serum or plasma with 99 percentile precision compared to traditional assays. It can also detect smaller changes in a patient’s troponin level over time.

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

Due to an increased number of chest pain complaints, there occur more than 8 million emergency room visits in a year. Only around 5 percent were related to myocardial infarctions.

Within 60 minutes after the heart attack, the presence of troponin in the bloodstream precisely indicates heart muscle damage. Hence by determining the slight changes of troponin levels in the blood over time, the physicians could effectively proceed with relevant treatment of these life-threatening conditions or discharge the patients.

These assays which meet the European Society of Cardiology guidelines have been made available in Europe since May 2017.

By Ddu
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