Ortho Receives the CE Mark for the NT-proBNP II Test Based on Enhanced VITROS® Immunodiagnostic Products, Assists in the Diagnosis and Assessment of Heart Failure



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RARITAN, N.J., July 23, 2019 / PRNewswire / – Ortho Clinical Diagnostics, one of the world's leading in vitro diagnostics, has announced the CE mark of an improved version of its VITROS® The NT-proBNP II test, which is part of the extensive Ortho heart menu. The badytical characteristics and clinical performance of the VITROS NT-proBNP II baday allow clinicians to effectively evaluate heart failure patients. The test is designed to facilitate the diagnosis of heart failure and the stratification of the risk of acute coronary syndrome and heart failure. It is also indicated to help badess the increased risk of cardiovascular events and mortality in patients with stable coronary artery disease and to badess the severity of heart failure in patients in whom heart failure occurs. has been diagnosed.

"We are committed to continuing the expansion of our cardiac supply with new and improved tests," he said. Heidi Casaletto, responsible for the product portfolio and marketing at Ortho. "With NT-proBNP II, clinicians can have confidence in the test results to aid diagnosis, badess severity and facilitate management of heart failure."

Patients with heart failure need quick and accurate diagnoses. According to the World Health Organization, 17.9 million people die each year from cardiovascular disease, including heart failure, accounting for about 31% of all deaths worldwide.I

The N-terminal pro-cerebral natriuretic peptide (NT-proBNP), measured by the VITROS NT-proBNP II baday, is recommended and used as a diagnostic aid for heart failure. NT-proBNP is not a target for angiotensin-neprilysin receptor blockers (Entresto®), recommended recommendation for the treatment of patients with heart failure. NT-proBNP is not a substrate for neprilysin and is a more appropriate biomarker than BNP for heart failure in these patients.ii The clinical performance of the VITROS NT-proBNP II baday was validated at three regression thresholds based on age and at an age-independent exclusion threshold. These thresholds have already been validated in the International Collaborative studies of NT-proBNP (ICON) and ICON Reloaded.iii In addition, the test reinforced the robustness to endogenous and exogenous interference.

The CE marking of the VITROS NT-proBNP II baday follows Ortho's recent launch of its high CE-marked troponin I susceptibility test and is an essential tool for clinicians looking for improved strategies to identify more quickly and efficiently. more specifically patients have a heart attack. VITROS NT-proBNP II and hs Troponin I tests can be performed on Ortho VITROS® Integrated system XT 7600, the VITROS® Integrated System 5600, VITROS® 3600 and VITROS immunodiagnostic system® ECi / ECiQ immunodiagnostic systems.

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About Ortho Clinical Diagnostics

Ortho Clinical Diagnostics is a world leader in in vitro diagnostics for clinical laboratories and the community of immunohematology. From hospitals, hospital networks, blood banks and laboratories in more than 125 countries and territories, Ortho's high quality products and services enable healthcare professionals to make healthcare decisions. more enlightened treatment. For the community of immunohematology, Ortho's blood typing products help ensure that each patient receives safe blood, the right type and the right unit. Ortho brings to clinical laboratories around the world sophisticated test technologies, automation, information management and interpretation tools, to help them run more efficiently and effectively. improve patient care. The goal of Ortho is to improve and save lives with diagnoses, and it does so by reinventing what is possible. That's what Ortho has been defining for more than 75 years and is driving Ortho forward. For more information, visit www.orthoclinicaldiagnostics.com.

© Ortho Clinical Diagnostics 2019

PR-05121

I https://www.who.int/cardiovascular_diseases/en
ii Karen Titus, CAP today, November 2015, p66
iii https://www.ncbi.nlm.nih.gov/pubmed/29544601; https://www.ncbi.nlm.nih.gov/pubmed/16293638

SOURCE Ortho Clinical Diagnostics

Related Links

http://www.orthoclinical.com

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