Siemens’ Atellica IM High-Sensitivity Troponin I Test Cleared for Predicting Heart Attack in At-Risk Patients

October 18, 2024—Siemens Healthineers recently announced FDA clearance of a new progressive claim for its Atellica IM high-sensitivity troponin I (TnIH) test. The blood test can help health care providers identify patients at risk of death and major cardiac events that could occur up to 1 year after presenting to the emergency department with signs and symptoms of acute coronary syndrome, advised the company.

Siemens stated that the Atellica IM TnIH blood test is used to measure cardiac troponin I in a patient’s blood as a specific and sensitive biomarker indicating heart muscle injury, and that the Atellica IM TnIH test may provide information about impending risk for the large number of chest pain patients who do not receive a current heart attack diagnosis. As many as 48.9% of patients with an elevated cardiac troponin I result will go on to experience death or a major adverse cardiac event.

The information provided by the test can potentially help reduce high readmission rates associated with cardiac emergency department visits—30% readmission rates were observed within the first 12 months after initial MI, noted the company.

According to the company, the guideline-acceptable high-sensitivity troponin I tests are well-established aids in the diagnosis of heart attack for use on the Atellica Solution, Atellica CI Analyzer, and ADVIA Centaur platforms.

With a 10-minute time to first result, the Atellica IM TnIH test now can be used as an aid in prognosis for 30-, 90-, 182-, and 365-day all-cause mortality and major adverse cardiac events (myocardial infarction, urgent revascularization, cardiac death, or heart failure hospitalization) in patients presenting with signs and symptoms suggestive of acute coronary syndrome.

“The new Atellica IM TnIH indication helps us predict which patients may be on the cusp of a major cardiac event,” commented Alan H.B. Wu, PhD, in Siemens’ press release.

Dr. Wu, who is Core Lab Co-Director at Zuckerberg San Francisco General Hospital in San Francisco, California, continued, “We learned that nearly 50% of the patients that presented with elevated TnIH results, and a history of cardiac events are at risk for heart attack and/or death. Now this assay, in combination with a robust clinical assessment, can inform physicians on immediate and long-term management of patients to reduce risks for adverse events.”

Siemens Healthineers stated that the test was first cleared by the FDA for in vitro diagnostic use in the quantitative measurement of cardiac troponin I in human serum or plasma (lithium heparin) to aid in the diagnosis of acute myocardial infarction. Since its introduction, the blood test has widely demonstrated its clinical utility in patient care across the globe. The high-sensitivity troponin I blood test offers more precise clinical assessment with highly sensitive detection of acute myocardial infarction in both sexes, noted the company.