Siemens Healthineers has announced a new prognostic claim for its Atellica IM High-Sensitivity Troponin I (TnIH) test, significantly enhancing care for at-risk cardiac patients in the U.S. This straightforward blood test allows healthcare providers to identify patients at risk of death and major cardiac events that may occur within a year after they present to the emergency department with symptoms of acute coronary syndrome. It is the first test of its kind in the U.S. to receive FDA clearance for prognostic use.
Over 7 million individuals visit U.S. emergency departments (EDs) each year with chest pain, prompting extensive diagnostic efforts to determine if they are experiencing a heart attack. The Atellica IM High-Sensitivity Troponin I (TnIH) blood test is utilized in many hospitals to measure cardiac troponin I, a specific biomarker indicating heart muscle injury.
For the substantial number of chest pain patients who do not receive a current heart attack diagnosis, the Atellica IM TnIH test can provide insights into their future risk. Research indicates that nearly 48.9% of patients with elevated cardiac troponin I levels may face death or a major adverse cardiac event.
Dr. Alan H.B. Wu, Core Lab Co-Director at Zuckerberg San Francisco General Hospital, commented, “The new Atellica IM TnIH indication helps us identify patients at risk for significant cardiac events. We found that almost 50% of patients with elevated TnIH results and a history of cardiac events are at risk for heart attack and/or death. This assay, along with thorough clinical evaluation, can guide physicians in managing patients to reduce adverse event risks.”
This information could potentially lower high readmission rates associated with cardiac ED visits, where approximately 30% of patients are readmitted within the first year after an initial myocardial infarction. Michele Zwickl, head of laboratory solutions for Diagnostics at Siemens Healthineers North America, stated, “If just one patient is better triaged because of this blood test, it could lead to faster intervention, prevent readmission, or even save a life.” It is estimated that up to 12% of patients may die within a year following a heart attack.
The High-Sensitivity Troponin I tests are already established tools for diagnosing heart attacks on various platforms, including the Atellica Solution and ADVIA Centaur. With a 10-minute turnaround for initial results, the Atellica IM TnIH test can now aid in prognosis for mortality and major adverse cardiac events (MACE) at 30, 90, 182, and 365 days in patients presenting with signs of acute coronary syndrome (ACS). MACE includes myocardial infarction, urgent revascularization, cardiac death, or heart failure hospitalization.
Initially cleared by the FDA for in vitro diagnostic use to measure cardiac troponin I, the test has demonstrated significant clinical utility globally. The high-sensitivity troponin I blood test allows for more accurate assessment of acute myocardial infarction in both men and women. More information about the Atellica IM TnIH test can be found on the Siemens Healthineers website.
Siemens Healthineers is dedicated to advancing healthcare worldwide, providing equipment, solutions, and services in over 180 countries. As a leading medical technology company, it aims to improve access to healthcare for underserved communities and tackle major health challenges. In fiscal 2023, Siemens Healthineers had approximately 71,000 employees and generated around €21.7 billion in revenue.
