Firm says approval completes cardiovascular product line for benchtop immunoanalyzer.
FDA has granted 510(k) clearance for Mitsubushi Chemical Medience’s Pathfast® cTnI-II (cardiac troponin I) test for assessing levels of cardiac troponin in the diagnosis of cardiac muscle damage. Mitsubishi says clearance of the test in the U.S. completes the cardiovascular assay line for the Pathfast benchtop chemiluminescence immunoanalyzer system, which already includes tests for N-terminal pro brain natriuretic peptide, D-dimer, myoglobin, creatinine kinase, and high-sensitivity C-reactive protein.
“We are confident the test will be widely accepted in the U.S. market, in accordance with international guidelines,” comments Toshihiko Yoshitomi, Ph.D., president and CEO. “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 Pathfast system is designed to eliminate the need for centrifugation of a test specimen, can be used with either plasma or serum, and generates results in just 17 minutes, the company says. Over 1,000 units have already been sold in Asia, Europe, and Latin America. The firm in addition claims that due to its absolute coronary specificity and sensitivity, cardiac troponin I is considered the preferred biomarker for diagnosing cardiac muscle damage, particularly after a heart attack.