Siemens Healthineers Offers True High-Sensitivity Troponin I IVD Assay for Earlier Diagnosis of Myocardial Infarctions

Siemens Healthineers has announced the availability of its new high-sensitivity troponin I (TNIH)¹ in vitro diagnostics assay, designed to aid in diagnosing acute myocardial infarctions (AMI) through the quantitative measurement of cardiac troponin I in serum or plasma. High-sensitivity troponin plays a critical role in the timely diagnosis of AMI, or heart attacks. AMI can be life-threatening if not treated as soon as possible because as blood flow to the heart is blocked, the heart muscle begins to die in as few as 30 to 60 minutes.

“With the introduction of the high-sensitivity troponin I assay, Siemens Healthineers is continuing to deliver proven technologies that address the global need to improve cardiac care with fast, reliable diagnostic options for better patient outcomes,” said Franz Walt, President, Laboratory Diagnostics, Siemens Healthineers. “This new assay will provide clinicians with actionable results and the confidence to act swiftly earlier.”

The presence of cardiac troponin is specific to heart muscle death. The detection of circulating troponins has long been recognized as the gold standard for the diagnosis of AMI in patients who present with chest pain in the emergency room. Fast, accurate troponin testing that delivers actionable results to help clinicians rule-in or rule-out AMI quickly is critical to optimal patient outcomes.

Compared to traditional troponin assays, the Siemens Healthineers TNIH assay is able to detect lower levels of troponin and smaller changes to a patient’s troponin levels, which may be an early indication of AMI. This design affords clinicians greater confidence in patient results at the low end of the assay range by delivering precision that provides the ability to measure slight, yet critical, changes between serial troponin I values. Precision at the low end is important to minimize analytic variation that could confuse a clinician’s assessment of a clinically significant change. With this data in hand, clinicians have the ability to more quickly diagnosis and treat patients with suspected AMI, in some cases in as little as one to three hours.

“The clinical availability of this new assay will allow more institutions to provide the best and guideline-based management. This is very good news for patients,” commented Christian Mueller, MD, Head, Cardiovascular Research Institute Basel, University Hospital, Switzerland.

The TNIH assay meets current European Society of Cardiology guideline recommendations. Further, clinical study data involving approximately 2,500 patients at different time points from more than 30 trial sites in the United States and Europe demonstrate the TNIH assay’s efficiency.

The TNIH assay from Siemens Healthineers is available for use on the ADVIA Centaur XPT and ADVIA Centaur XP systems, the company’s high efficiency laboratory analyzers. The company also plans to make the high-sensitivity troponin I assays available on its other testing systems, including the Dimension Vista², Dimension EXL² and Atellica IM Analyzer².

Cardiovascular diseases remain the biggest cause of deaths worldwide. By 2030, almost 23.6 million people will die from cardiovascular diseases—mainly from heart disease.³ Siemens Healthineers offers customers the benefit of a comprehensive cardiac menu, including its new high-sensitivity troponin I and a choice of natriuretic peptide solutions.

With products and offerings such as a comprehensive cardiac menu, as well as a new name that underlines the company’s pioneering spirit and engineering expertise, Siemens

Healthineers—the separately managed healthcare business of Siemens AG—is helping to enable healthcare providers worldwide to meet current challenges and excel in their respective environments.

¹ Not available for sale in the U.S. Product availability may vary from country to country and is subject to varying regulatory requirements.

² Under development. Not available for sale. Product availability will vary from country to country and will be subject to varying regulatory requirements.

³ World Health Organization http://www.who.int/cardiovascular_diseases/about_cvd/en/