In a press release, Ortho Clinical Diagnostics announced the CE Mark of an enhanced version of its VITROS NT-proBNP II assay, part of Ortho’s expansive cardiac menu. The analytical characteristics and clinical performance of the VITROS NT-proBNP II assay allow clinicians to efficiently assess heart failure patients. The assay is designed for the aid in diagnosis of heart failure and for the risk stratification of acute coronary syndrome and heart failure. It is further indicated as an aid in the assessment of increased risk of cardiovascular events and mortality in patients who have stable coronary artery disease and in the assessment of heart failure severity in patients diagnosed with heart failure.
Patients experiencing heart failure need quick and accurate diagnoses. According to the World Health Organization, there are 17.9 million deaths each year from cardiovascular diseases, including heart failure, that make up approximately 31 percent of all deaths worldwide.
N-terminal pro Brain Natriuretic Peptide (NT-proBNP), measured by the VITROS NT-proBNP II assay, is recommended and used as an aid in the diagnosis of heart failure. NT-proBNP is not a target for the angiotensin receptor-neprilysin inhibitors (Entresto), a guideline recommended treatment for heart failure patients. NT-proBNP is not a neprilysin substrate and is a more suitable biomarker than BNP for heart failure in these patients. The clinical performance of the VITROS NT-proBNP II assay was validated at three age-dependent rule-in cutoffs and at one age-independent rule-out cutoff. These cutoffs have been previously validated in the International Collaborative of NT-proBNP (ICON) and ICON Reloaded studies. In addition, the assay has enhanced robustness to endogenous and exogenous interferences.
The CE Mark of the VITROS NT-proBNP II assay comes on the heels of Ortho’s recent launch of its High Sensitivity Troponin I assay, also CE Marked and 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 hs Troponin I assays can run on Ortho’s VITROS XT 7600 Integrated System, the VITROS 5600 Integrated System, VITROS 3600 Immunodiagnostic System, and the VITROS ECi/ECiQ Immunodiagnostic Systems.