TOKYO, June 14, 2011 /PRNewswire/ — Mitsubishi Chemical
Medience Corporation announced today that the U.S. Food and Drug
Administration (FDA) has granted 510(k) premarketing notification
clearance to the PATHFAST® cTnI-II (cardiac Troponin I)
diagnostic test, clearing the way for its sale in the United
States. The test is designed to be used with the PATHFAST analysis
system, a unique, self-contained, bench-top chemi-luminescence
immunoanalyzer that rapidly measures concentrations of emergency
biomarkers from a single whole blood sample.
The PATHFAST cTnI-II test determines the quantity of cardiac
troponin I, a protein that is integral to cardiac muscle
contraction, which is elevated in the bloodstream after damage to
the myocardium (the middle and thickest layer of the heart
wall).(1),(2) Due to its absolute coronary specificity and high
sensitivity, cardiac troponin I is considered the preferred
biomarker for diagnosing cardiac muscle damage, particularly
following a heart attack.
“We are pleased that the FDA has recognized the utility of the
PATHFAST system for measuring levels of cardiac troponin I in whole
blood, and are confident the test will be widely accepted in the
U.S. market, in accordance with international guidelines,”
commented Dr. Toshihiko Yoshitomi, President and CEO of Mitsubishi
Chemical Medience. “Today’s news is also an important step in
supporting our ongoing negotiations to secure a strategic
distribution partnership to launch the PATHFAST product line in the
U.S. by early 2012.”
The 510(k) clearance of the PATHFAST cTnI-II 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).
With its whole blood use capability, the PATHFAST system eliminates
the need for centrifugation of the sp
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