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

2024-03-27

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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

CORTLANDT MANOR, N.Y., March 27, 2024 /PRNewswire/ -- 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.

PATHFAST hs-cTnI-II becomes first and only hs-cTn test cleared for point-of-care use in the United States.

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"Both speed and quality in high-sensitivity cardiac troponin testing are essential in the emergency department for safe and timely disposition of patients. Access to rapid and accurate results can assist clinicians in identifying patients through safe, early rule-out protocols that can decrease 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," said Robert H. Christenson, Ph.D., DABCC, FADLM, FACC.

"Polymedco is committed to providing the most accurate and efficient diagnostics to help overburdened Emergency Departments more effectively and efficiently respond and treat patients presenting with symptoms of a heart attack. Having the diagnostic accuracy of high-sensitivity cardiac troponin at the point-of-care represents a significant advancement in cardiac care in the U.S.," said Polymedco CEO Doug White.

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.

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 vein thrombosis, pulmonary embolism, and inflammatory conditions by providing lab-quality results in minutes at the point of care.

Flexibility to run up to 6 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

About Polymedco

Polymedco partners with healthcare systems, payors, providers, and reference labs to develop best-in-class screening and early detection programs that can help identify life-threatening diseases earlier. We're proud to offer a portfolio of products with exceptional performance, robust clinical evidence, and user-friendly design.

Connect with Polymedco at www.polymedco.com, on LinkedIn at https://www.linkedin.com/company/polymedco, or on Facebook at https://www.facebook.com/Polymedco/

For more information: Polymedco Communications: Anthony Bercaw [email protected]

References:

1. 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 Committee. J Am Coll Cardiol. 2022;80(20):1925-1960. doi:10.1016/j.jacc.2022.08.750

2. 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/

SOURCE Polymedco, LLC