Beckman Coulter Gets FDA Clearance for High-sensitivity Access HsTnI Assay

Beckman Coulter

A global leader in Life Sciences and Diagnostic instrumentation, Beckman Coulter has announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance 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, this assay delivers advanced capabilities to aid in the diagnosis and management of acute myocardial infarction (MI). It detects troponin I-a protein that is present in circulation during MI-giving clinicians important insight into life-threatening cardiac conditions in patients presenting with chest pain.

According to the Centers for Disease Management and Control (CDC), about 610,000 people die of heart disease in the United States every year, which amounts to 1 in every 4 deaths, and every 40 seconds, someone in the United States has a heart attack or myocardial infarction. The first high-sensitivity troponin I assay available in the United States, Access hsTnI enables clinicians to provide efficiency improvements in cardiac patient management. It accurately identifies more than 94% of true acute MI patients in as little as one hour after patient presentation. The assay's new design delivers the high-quality results needed to distinguish between MI and other cardiac conditions. Beckman Coulter received the CE Mark for this assay in November 2017.

The Access hsTnI assay provides laboratories with increased testing flexibility as it is the only high-sensitivity assay to use either plasma or serum samples. Along with detecting small differences in cTnI levels over time, the Access hsTnI assay also features high-sensitivity performance for excellent low-end sensitivity, providing a reliable measurement of very low levels of cardiac troponin I (cTnI).

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

Beckman Coulter has also expanded and refreshed its assay menu to include Access Sensitive Estradiol, Anti-Müllerian hormone, thyroid-stimulating hormone, vitamin D and beta-human chorionic gonadotropin, which are designed to meet customer needs and new industry and regulatory guidelines.

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