Siemens Healthineers has received the US Food and Drug Administration (FDA) clearance for the Atellica IM High-Sensitivity Troponin I (TnIH) test.
The Atellica IM TnIH is a blood test designed to predict patient risk of cardiac events or death for up to one year.
The new test enhances care for at-risk cardiac patients in the US. It helps healthcare providers identify patients at risk of death and major cardiac events within a year of presenting with acute coronary syndrome symptoms.
The Atellica IM TnIH blood test is widely used in hospitals across the country to measure cardiac troponin I levels. Cardiac troponin I is a biomarker that signals heart muscle injury.
It is now said to be the only test in the US with a specific prognostic risk intended use. Its prognostic capabilities aid in prevention, supporting longer-term care plans and improving patient outcomes.
For the many chest pain patients without a current heart attack diagnosis, the Siemens Healthineers’ test offers insights into their impending risk.
The German healthcare technology company said this information can help reduce high readmission rates linked to cardiac emergency department visits.
Siemens Healthineers North America Diagnostics laboratory solutions head Michele Zwickl said: “If just one patient is triaged more effectively because of the clinical information this blood test provides, it could lead to faster intervention, prevent hospital readmission, or even save a life.”
Troponin I tests are well-established tools for diagnosing heart attacks on the Atellica Solution, Atellica CI Analyzer, and ADVIA Centaur platforms.
The Atellica IM TnIH test delivers results in just 10 minutes and aids in assessing 30-, 90-, 182-, and 365-day all-cause mortality and major adverse cardiac events (MACE) for patients with acute coronary syndrome (ACS) symptoms.
Initially cleared by the FDA in 2018 for in vitro diagnostic use, the test quantifies cardiac troponin I in human serum or plasma to support acute myocardial infarction diagnosis.
Since its launch, the blood test has shown clinical utility worldwide, Siemens Healthineers claimed.
The troponin I test enables precise assessment and sensitive detection of AMI in both men and women.
In August this year, Siemens Healthineers announced an offer to acquire the molecular imaging business of Swiss pharmaceutical firm Novartis.
