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Ortho Clinical Diagnostics Receives CE Mark for Enhanced Cardiac Assay

NEW YORK – Ortho Clinical Diagnostics today announced it has received CE marking for an enhanced version of its Vitros NT-proBNP II assay to diagnose heart failure and enable risk stratification of heart failure and acute coronary syndrome.

Clinicians can also use the assay to assess heart failure severity and the increased risk of cardiovascular events and mortality in patients who have stable coronary artery disease, Raritan, New Jersey-based Ortho said.

N-terminal pro brain natriuretic peptide (NT-proBNP) is used in diagnostic tests to diagnose heart failure.

Ortho said the enhanced version of its test has improved assay quality through the use of monoclonal antibodies, enhanced robustness to potential interferences, and rule-in and rule-out clinical performance. The firm said the assay's performance was validated at three age-dependent rule-in cutoffs and at one age-independent rule-out cutoff, and that it has enhanced robustness to endogenous and exogenous interferences.

Ortho noted that CE marking of the Vitros NT-proBNP II assay comes on the heels of the recent launch of its high sensitivity troponin I assay, a critical tool for clinicians who are seeking improved strategies to more rapidly and accurately identify patients suffering from a heart attack. Both the Vitros NT-proBNP II and high sensitivity troponin I assays can run on the firm's Vitros XT 7600 Integrated System, Vitros 5600 Integrated System, Vitros 3600 Immunodiagnostic System, and Vitros ECi/ECiQ Immunodiagnostic System.