Siemens Healthineers has received FDA clearance for its Atellica IM high-sensitivity troponin I (TnIH) blood test, extending its prognostic capabilities to predict the risk of major cardiac events and death up to one year in advance. This marks the first test of its kind in the United States to receive FDA clearance for such a long-term prognosis.
The Atellica IM TnIH blood test is designed to measure cardiac troponin I, a specific and sensitive biomarker that indicates heart muscle injury. Many U.S. hospitals already utilize this test for assessing cardiac risk. The expanded indication aims to improve the management of patients at risk of heart attacks and reduce high readmission rates related to cardiac emergency department visits.
Clinical Implications
Dr. Alan H.B. Wu, core lab co-director at Zuckerberg San Francisco General Hospital, stated that the new indication helps predict which patients may be on the cusp of a major cardiac event. He noted that nearly 50% of patients with elevated TnIH results and a history of cardiac events are at risk for heart attack and/or death. The assay, combined with a robust clinical assessment, can inform physicians on immediate and long-term patient management to reduce risks for adverse events.
Impact on Cardiovascular Care
Cardiovascular disease remains the leading cause of death in the U.S., with an American dying every 33 seconds, according to the Centers for Disease Control and Prevention. Siemens Healthineers emphasizes that the Atellica IM test could lead to more effective triage, faster intervention, and potentially save lives by providing crucial clinical information.
Michele Zwickl, head of laboratory solutions for diagnostics at Siemens Healthineers North America, highlighted the potential impact, stating that even if just one patient is triaged more effectively due to the blood test's clinical information, it could lead to faster intervention, prevent hospital readmission, or even save a life.
