FDA clears PATHFAST high-sensitivity cardiac troponin I test
PATHFAST hs-cTnI-II becomes first and only hs-cTn test cleared for point-of-care use in the United States, delivering results up to three times faster than core lab testing
3 Apr 2024
PATHFAST® hs-cTnI-II, a breakthrough high-sensitivity troponin assay from Polymedco, developed for the PATHFAST Biomarker Analyzer, has received 510(k) clearance from the US 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 visits1. 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 care2, providing EDs and other acute care facilities the ability to make accurate diagnostic and treatment decisions much faster than previously available.
With the FDA clearance, the test may be sold in the US 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 an electrocardiogram (ECG), clinical findings and patient symptoms to aid in the diagnosis of heart attacks.
About the PATHFAST Biomarker Analyzer
PATHFAST facilitates critical care decisions through a comprehensive menu of lab tests used for patients with possible acute myocardial infarction, congestive heart failure, deep venous thrombosis, pulmonary embolism, and inflammatory conditions by providing lab-quality results in minutes at the point of care.
- Flexibility to run up to six tests at once from a small volume of whole blood or plasma
- Space-saving design ideal for the emergency department, STAT lab, or urgent care center
- Easy, user-friendly operation
References
Kontos M., de Lemos, J. et al. 2022 ACC Expert consensus decision pathway on the evaluation and disposition of acute chest pain in the emergency department: a report of the American College of Cardiology Solution Set Oversight
Point of care cardiac troponin I and T assay analytical characteristics. IFCC Committee on Clinical Applications of Cardiac Bio-Markers. Accessed March 13, 2024. https://ifcc.org/ifcc-education-division/emd-committees/committee-on-clinical-applications-of-cardiac-bio-markers-c-cb/biomarkers-reference-tables/