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news.Mitsubishi Chemical Medience has received approval from the US Food and Drug Administration (FDA) for its PATHFAST cTnI-II (cardiac Troponin I) diagnostic test.
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PATHFAST cTnI-II test should be used with the PATHFAST analysis system, a chemi-luminescence immunoanalyzer that measures concentrations of emergency biomarkers from a single whole blood sample.
The test determines the quantity of cardiac troponin I and due to its coronary specificity, cardiac troponin I is considered the biomarker for diagnosing cardiac muscle damage, particularly following a heart attack.
The FDA clearance of the test completes the cardiovascular product line of the PATHFAST analysis system, which also includes tests to determine quantities of N-terminal pro brain natriuretic peptide (NT-proBNP), D-Dimer, myoglobin, creatinine kinase (CK)-MB and high-sensitivity C-reactive protein (hsCRP).