Pharmaceutical Business review

FDA approves Mitsubishi cardiac Troponin test

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).