Polymedco has received 510(k) clearance from the US Food and Drug Administration (FDA) for its rapid troponin assay as part of its Pathfast Biomarker Analyser.
The troponin assay (hs-CTnl-II) detects the presence of cardiac troponin I, an acute change in its concentration is indicative of myocardial infarction. It is a biomarker of choice for diagnosing acute myocardial infarction.
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The lab test for cardiac troponin takes an hour or more to give results, the Pathfast platform can provide point-of-care results in 17 minutes. Early detection of myocardial infarction allows physicians to administer early treatment, thereby, preventing ischaemic injury.
The market for cardiac biomarker tests is expected to grow from being worth $1.48bn in 2023 to over $1.7bn by 2033, according to GlobalData market analysis. There are 11 point-of-care troponin tests currently in development, as per a GlobalData report.
Multiple companies have developed point-of-care cardiac troponin tests. QuidelOrtho’s Quidel Triage Cardiac Panel measures cardiac troponin biomarkers and produces results in about 20 minutes. In July 2023, the company was hit with a Class I recall by the FDA after its test reported falsely low or false negative troponin levels.
Other advances in cardiac disease diagnostics include CorVista Health’s non-invasive medical device system with a coronary artery disease (CAD) add-on option for detecting the presence of cardiac disease. The devices analyses sensor-acquired physiological signals from patients presenting with cardiovascular symptoms such as fatigue, chest pain and dyspnoea, to aid in diagnosing CAD.
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By GlobalDataCardio Diagnostics has also developed an AI-driven molecular heart disease test, which analyses epigenetic and genetic biomarkers from a patient’s blood sample using AI to identify individuals at risk of CAD. The test has shown an 88% sensitivity and a 51% specificity in a clinical trial.
Earlier this year, Polymedco joined the CancerX initiative to develop colorectal cancer screening and early detection solutions. CancerX was launched in 2023, as part of the public-private partnership White House Cancer Moonshot programme launched by US President Joe Biden and First Lady Jill Biden. The initiative aims to prevent more cancer deaths and accelerate progress in cancer research, diagnosis and treatment.
