Beckman Coulter Diagnostics Receives Health Canada Clearance for Access hsTnI, its New High Sensitivity Troponin Assay

New assay enables hospitals to provide efficiency improvements in cardiac patient management

BREA, Calif. — (June 26, 2018) — Beckman Coulter Diagnostics announced today that it has received Health Canada clearance for its new high sensitivity troponin (hsTnI) assay, Access hsTnI, that aids in diagnosing myocardial infarction for patients presenting with chest pain or other ischemic symptoms.

Troponin is a specific cardiac biomarker that points to cardiac cell death. It is ordered to help diagnose a heart attack or injury to the heart muscle, which is the leading cause of hospitalization and the second-leading cause of death in Canada.1,2 The ability to detect low levels and small changes in troponin can have a significant impact on treatment and, subsequently, the quality of life for the person presenting with chest pain.

The Canadian economy spends more than $20.9 billion each year to treat cardiovascular disease.3 Twerenbold et al. evaluated the impact of clinical introduction of hsTn assay in 2,544 patients presenting with symptoms suggestive of acute myocardial infarction (AMI) to the emergency department in European hospitals and found, overall, patients’ median time to discharge from the emergency department decreased by 79 minutes─lowering cost in outpatient settings on average by 20 percent─after the introduction of hsTn assay.4

“Beckman Coulter's high-sensitivity cardiac troponin I assay can measure very-low cardiac troponin concentrations with excellent precision. This test may help physicians for both the early diagnosis of myocardial infarction and for future risk stratification in and outside the acute coronary syndrome setting,” said Peter Kavsak, Ph.D., associate professor, Department of Pathology and Molecular Medicine at McMaster University. In comparison to contemporary troponin assays, high-sensitivity assays demonstrate significantly improved precision at and below the 99th percentile upper reference limit (URL), allowing better discrimination of small differences in troponin values between serial measurements. Multiple studies confirm that high-sensitivity assays detect cTnl release earlier, increasing sensitivity for myocardial infarction diagnosis at presentation. This may help physicians diagnose myocardial infarction earlier in the course of care.

In Canada, men are also two times more likely to suffer a heart attack than women. It is important to know the symptoms of a heart attack as they vary between men and women. In addition, the levels of troponin are different for males and females. Access hsTnI has sex-specific cutoffs for men and women. The sex-specific cutoffs that are now reported in whole numbers, provides clinicians with clearer and easier-to-interpret results.

Beckman Coulter Diagnostics is committed to helping clinical partners focus on continuous improvement. The new high-quality hsTnI assay exemplifies this commitment by enabling hospitals to develop fast-track protocol resulting in early discharge for patients with suspected myocardial infarction.

The Access hsTnI assay is available for use on the Access 2, DxI and the entire Beckman Coulter family of Access immunoassay systems.

About Beckman Coulter Diagnostics
Beckman Coulter Diagnostics helps healthcare and laboratory professionals provide better patient care by delivering the accurate diagnostic information they need, when they need it. With a rich 80-year history, Beckman Coulter is a strong partner for healthcare organizations. Our scalable instruments, comprehensive diagnostic tests and business management services are trusted by hospitals, laboratories and other critical care settings around the world. We share in our customers' mission toward continuous improvement and quality patient care because we believe when efficiency and clinical outcomes are improved, patients benefit and we can move healthcare forward for every person.


4. Twerenbold R, et al. Impact of high-sensitivity cardiac troponin on use of coronary angiography, cardiac stress testing, and time to discharge in suspected acute myocardial infarction. Eur Heart J. Nov 21; 37(44):3324-3332

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