Polymedco announces US FDA clearance of the PATHFAST high-sensitivity cardiac troponin I (hs-cTnI-II) test as an aid in the diagnosis of myocardial infarction

April 1, 2024- The PATHFAST hs-cTnI-II, a breakthrough high-sensitivity troponin assay developed for the PATHFAST Biomarker Analyzer, received 510(k) clearance from the U.S. Food and Drug Administration (FDA). This new test will facilitate the accurate, rapid diagnosis of myocardial infarction at the point of care. The PATHFAST point-of-care platform offers a comprehensive menu of tests that bring central lab-quality diagnostic results closer to the clinician and patient, saving valuable time when evaluating patients with potentially life-threatening conditions.

Chest pain remains the second most common reason for adults to seek care at the emergency department (ED) in the United States, accounting for over 7 million annual visits.1 Timing of troponin test results is a critical factor in helping doctors quickly diagnose and effectively treat patients.
When patients enter the ED with a suspected heart attack, doctors typically use a troponin blood test to aid in their diagnosis. Before the introduction of the PATHFAST high-sensitivity troponin assay, the test was only available in the hospital central laboratory where results typically can take an hour or more to get to the physician. The PATHFAST platform delivers results in 17 minutes at the point of care,2 providing EDs and other acute care facilities the ability to make accurate diagnostic and treatment decisions much faster than previously available.

With this clearance, the test may be sold in the U.S. for use on Polymedco’s PATHFAST analyzer with whole blood and plasma patient specimens. PATHFAST High Sensitivity Troponin-I results should be used in conjunction with other diagnostic information such as electrocardiogram (ECG), clinical findings and patient symptoms to aid in the diagnosis of heart attacks.

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