Polymedco’s Rapid Troponin Assay Receives FDA Clearance

Polymedco has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its rapid troponin assay, a crucial component of its Pathfast Biomarker Analyzer. This high-sensitivity cardiac troponin I (hs-CTnI-II) assay swiftly detects acute changes in cardiac troponin I concentration, aiding in the diagnosis of myocardial infarction, commonly known as heart attack. Unlike traditional lab tests, which can take over an hour, the Pathfast platform delivers point-of-care results in just 17 minutes, enabling swift diagnosis and early treatment to prevent ischaemic injury.

The approval of Polymedco's rapid troponin assay comes at a critical juncture, with the market for cardiac biomarker tests projected to witness substantial growth, reaching over $1.7 billion by 2033. However, challenges persist in this arena, as evidenced by recent recalls and ongoing developments in point-of-care troponin tests. Despite setbacks, advances in cardiac disease diagnostics, such as non-invasive medical devices and AI-driven molecular tests, offer promising avenues for early detection and intervention. Polymedco's participation in initiatives like CancerX further underscores its commitment to advancing healthcare solutions beyond cardiac care, aligning with broader public-private efforts to combat cancer and accelerate progress in medical research and treatment.

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