Research & Development
Polymedco's PATHFAST hs-cTnI-II test receives US FDA clearance
28 March 2024 -

US-based screening and early detection specialist Polymedco LLC announced on Wednesday that it has received US Food and Drug Administration (FDA) approval for the PATHFAST high-sensitivity cardiac troponin I (hs-cTnI-II) test as an aid in the diagnosis of myocardial infarction.

According to Polymedco, PATHFAST hs-cTnI-II is the first and only hs-cTn test cleared for point-of-care use in the United States, delivering outcomes up to three times faster than core lab testing. It is intended to facilitate the accurate, rapid diagnosis of myocardial infarction at the point of care.

The PATHFAST point-of-care platform is designed to provide a comprehensive menu of tests that bring central lab-quality diagnostic results closer to the clinician and patient, saving valuable time when assessing patients with potentially life-threatening conditions.

It delivers results in 17 minutes at the point of care, providing EDs and other acute care facilities with the ability to make accurate diagnostic and treatment decisions faster than previously available. The PATHFAST platform generates outcome in 17 minutes at the point of care.

With this clearance, the test may be sold in the US for use on Polymedco's PATHFAST analyser 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.