Beckman Coulter Diagnostics Receives U.S. FDA 510(k) Clearance for High- sensitivity Access hsTnI Assay

BREA, Calif., June 27, 2018 /PRNewswire/ -- Beckman Coulter Diagnostics announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new high-sensitivity troponin (hsTnI) assay, Access hsTnI, for use on the Access 2, DxI and the entire Access family of immunoassay systems. The Access hsTnI assay detects troponin I—a protein that is present in circulation during myocardial infarction (MI)—giving clinicians important insight into life-threatening cardiac conditions in patients presenting with chest pain.

Access hsTnI, a true high-sensitivity troponin I assay, demonstrates <10% CV at the upper reference limits (URL) for men and women and detects troponin in >50% of the healthy population. In an independent study, Access hsTnI detected >99% of troponin values for healthy men and women.¹ As the only high-sensitivity troponin I assay available in the U.S., Access hsTnI enables clinical laboratories to confidently report accurate results for clinical decision making in the acute-care setting. Laboratories have increased testing flexibility with this assay as it is the only high-sensitivity assay to use either plasma or serum samples.

Heart disease is the number one cause of death in the U.S. Every 40 seconds, someone experiences an MI, and, every year, chest pain and related symptoms send 8 million patients to the emergency department (ED).² Only 5.5% of those entering the ED, however, are diagnosed with a serious condition, including MI.³ Beckman Coulter Diagnostics is committed to helping clinical partners focus on diagnosing MI and other significant cardiac events faster and with greater accuracy. The Access hsTnI assay helps clinicians to accurately identify >94% of true acute MI patients in as little as one hour after patient presentation.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 with both the early diagnosis of myocardial infarction and 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.

The Access hsTnI assay features high-sensitivity performance for excellent low-end sensitivity, providing a reliable measurement of very low levels of cardiac troponin I (cTnI), while also detecting small differences in cTnI levels over time. In comparison to standard troponin assays, high-sensitivity assays demonstrate significantly improved precision at and below the 99th percentile URL, allowing better discrimination of small differences in troponin values between serial measurements.

"The most common cause of death in women is heart disease. Women sometimes do not exhibit the same symptoms as men when experiencing a heart attack. Because women tend to have lower troponin levels than men, their treatment may be delayed," said Michael Samoszuk, M.D., vice president and chief medical officer, Beckman Coulter Diagnostics. "Access hsTnI enables more accurate identification of women with myocardial infarction by providing separate sex-specific upper reference limits."

More precise determination of the 99th percentile URL has also led to an ability to report distinct reference ranges for men and women. Multiple studies confirm that high-sensitivity assays detect cTnl release earlier, increasing sensitivity for MI diagnosis at presentation. This may help physicians to diagnose MI earlier in the course of care.

Access hsTnI utilizes a new robust design to minimize the effects of pre-analytical variability and known interferences. This new design helps deliver high-quality results needed to distinguish between MI and other cardiac conditions. It will help with rapid MI diagnosis and enable physicians to confidently exclude MI in as little as one hour after patient presentation to the ED, providing efficiency improvements in cardiac patient management.

Beckman Coulter, a leader in immunoassay testing, continues to lead assay innovation with the launch of Access hsTnI. In addition, Beckman Coulter has expanded and refreshed its assay menu to include Access Sensitive Estradiol, Anti-Müllerian hormone, thyroid-stimulating hormone, vitamin D and beta-human chorionic gonadotropin. These products have been designed to meet customer needs and new industry and regulatory guidelines.

About Beckman Coulter
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.

References:

1. Pretorius, C.J., et. al. "A critical evaluation of the Beckman Coulter Access hsTnI: Analytical performance, reference interval and concordance." Clinical Biochemistry, vol. 55, 2018 May, pp. 49–55. https://doi.org/10.1016/j.clinbiochem.2018.03.003. Accessed 22 June 2018.
2. "Heart Attack." 2017. http://www.cdc.gov/heartdisease/heart_attack.htm. Accessed 22 June 2018.
3. Hsia RY, Hale Z and Tabas JA. "A National Study of the Prevalence of Life-threatening Diagnoses in Patients with Chest Pain." JAMA, Vol. 176, No. 7. 2016, pp. 1029-32. doi:10.1001/jamainternmed.2016.2498.
4. Greenslade,J, E. Carlton, C. Van Hise, E. Cho, T. Hawkins, W. Parsonage, J. Tate, J. Ungerer, and L. Cullen. "Diagnostic Accuracy of a New High-Sensitivity Troponin I Assay and Five Accelerated Diagnostic Pathways for Ruling Out Acute Myocardial Infarction and Acute Coronary Syndrome."Ann Emerg Med. 2018 Apr;71(4):439-451

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