The US Food and Drug Administration (FDA) has granted 510(k) clearance for the PATHFAST hs-cTnI-II, a high-sensitivity troponin assay designed for use with the PATHFAST Biomarker Analyzer. This breakthrough test promises to revolutionize the diagnosis of myocardial infarction by providing accurate results rapidly at the point of care.

Chest pain ranks as the second most common reason for adults visiting emergency departments (EDs) in the United States, with over 7 million annual visits. Prompt diagnosis is crucial in treating patients suspected of having a heart attack. Traditionally, troponin blood tests, vital for diagnosis, were only available in hospital central laboratories, where results could take an hour or more to reach physicians. However, the PATHFAST platform now delivers results in just 17 minutes at the point of care, significantly expediting diagnostic and treatment decisions in EDs and acute care settings.

Dr. Robert H. Christenson, an expert in clinical chemistry and laboratory medicine, emphasized the importance of rapid and accurate high-sensitivity troponin testing in the ED. "Access to rapid and accurate results can assist clinicians in identifying patients through safe, early rule-out protocols that can decrease the length of stay, reduce overcrowding, and improve patient satisfaction, all while assuring that patients with abnormal findings suggestive of acute coronary syndromes and myocardial infarction receive appropriate care," he said. 

Doug White, CEO of Polymedco, the company behind the PATHFAST platform, expressed their commitment to providing accurate and efficient diagnostics to support overburdened EDs. "Having the diagnostic accuracy of high-sensitivity cardiac troponin at the point-of-care represents a significant advancement in cardiac care in the US," he said.

With FDA clearance, the PATHFAST hs-cTnI-II test can now be marketed in the US for use on Polymedco's PATHFAST analyzer with both whole blood and plasma patient specimens. However, it's important to note that PATHFAST High Sensitivity Troponin-I results should be interpreted alongside other diagnostic information, including electrocardiograms (ECGs), clinical findings, and patient symptoms, to aid in the accurate diagnosis of heart attacks.