Ortho Clinical Diagnostics and Sphingotec Announce Strategic Agreement Regarding Novel Biomarker for Decreasing Re-hospitalizations in Heart Failure

RARITAN, N.J. and HENNIGSDORF, Germany, Dec. 7, 2017 /PRNewswire/ -- Ortho Clinical Diagnostics (Ortho), a global leader of in vitro diagnostics, and sphingotec GmbH today announced a long-term, global strategic agreement regarding the endothelial function marker, biologically active Adrenomedullin (sphingotest^® bio-ADM^®), which measures patients' rate of recovery from acute heart failure, providing critical information to physicians making treatment decisions.  The agreement allows Ortho to use the sphingotest^® bio-ADM^® immunoassay on Ortho's automated VITROS^® Immunodiagnostics and Integrated Systems for small-, mid- and high-volume clinical laboratories. Product availability is subject to local regulatory requirements.

"Ortho is committed to the continued expansion of our menu offerings, through both internal research and development programs and strategic collaborations," said Robert Yates, Ortho's chief operating officer.  "Our strategic agreement regarding the sphingotest^® bio-ADM^® assay positions us to bring this novel cardiac biomarker to a broad range of clinical labs around the world."

Congestion in acute heart failure, which is mainly caused by endothelial dysfunction, is a serious medical problem and a main driver of re-hospitalizations in these patients.  Next to the wide use of natriuretic peptides mainly for the diagnosis of heart failure, accurate determination of residual congestion during and after treatment is a high unmet medical need, to assess the adequacy of acute heart failure therapy.^[1]  In particular, residual heart congestion at hospital discharge is associated with a high risk of re-hospitalization and mortality, emphasizing the need for assessing and monitoring the adequacy of decongestion therapy throughout hospitalization.^[2] bio-ADM^® has been investigated in numerous clinical studies, showing its suitability to accurately diagnose residual congestion, monitor treatment effectiveness and determine suitability of patients for hospital discharge.

"Working with Ortho Clinical Diagnostics will help us deliver our standardized sphingotest^® bio-ADM^® assay to laboratories around the world to help them efficiently diagnose heart failure patients with residual congestion, in time for meaningful intervention, including a potential change in medication, to take place," said Andreas Bergmann, founder and general manager of sphingotec GmbH.

About sphingotest^® bio-ADM^®
The CE marked sphingotest^® bio-ADM^® immunoassay from sphingotec GmbH measures the bioactive form of Adrenomedullin, a peptide-hormone that is essential in maintaining the endothelial barrier function. sphingotest^® bio-ADM^® is indicated for use as an aid in monitoring de-congestion in patients hospitalized with acute heart failure.

About sphingotec GmbH
sphingotec GmbH develops innovative biomarkers for diagnosis, prediction and monitoring of acute medical conditions, such as acute heart failure, acute kidney injury and circulatory shock, in order to support patient management and provide guidance for treatment strategies. Furthermore, sphingotec develops biomarkers for the prediction of health risks, such as obesity, cardiovascular diseases and breast cancer, in order to support prevention strategies.

For more information, visit www.sphingotec.com.

About The VITROS^®Systems
The VITROS^® Chemistry, Immunodiagnostics and Integrated Systems from Ortho Clinical Diagnostics is a portfolio of products and patented enabling technologies which help clinical laboratories diagnose, monitor and treat disease. VITROS^® Products are engineered to help clinical laboratories with organizational, operational and economic challenges.

About Ortho Clinical Diagnostics
Ortho Clinical Diagnostics is a global leader of in vitro diagnostics serving the clinical laboratory and immunohematology communities. Across hospitals, hospital networks, blood banks and labs in more than 125 countries and territories, Ortho's high-quality products and services enable health care professionals to make better-informed treatment decisions. For the immunohematology community, Ortho's blood typing products help ensure every patient receives blood that is safe, the right type and the right unit. Ortho brings sophisticated testing technologies, automation, information management and interpretation tools to clinical laboratories around the world to help them run more efficiently and effectively and improve patient care. Ortho's purpose is to improve and save lives with diagnostics, and it does that by reimagining what's possible. This is what has defined Ortho for more than 75 years, and it's what drives Ortho forward. For more information, visit www.orthoclinicaldiagnostics.com .

[1] Daan Kremer, Biniyam G. Demissei and Adriaan A. Voors (2017) bio-ADM: Novel Marker of tissue Congestion in ADHF Patients. MEMC GREAT Meeting, Lisbon 08-09-2017

Parinello G. et al. (2015) Heart Fail Rev. January; 20(1): 13–24

Kremer D. et al. (2017) European Journal of Heart Failure; 19 (Suppl. S1) 5-601

Costanzo M.R. Heart Fail Rev (2012) 17:313–324

[2] Sam L. Teichman, Alan S. Maisel, and Alan B. Storrow, (2015) Challenges in Acute Heart Failure Clinical Management: Optimizing Care Despite Incomplete Evidence and Imperfect Drugs. Crit Pathways in Cardiol. 14: 12–24

sphingotec®, sphingotest®, the sphingotec and sphingotest logos and bio-ADM® are registered trademarks of sphingotec GmbH in Europe. For information regarding trademarks and other intellectual property applicable to this product, please see www.sphingotec.com.

SOURCE Ortho Clinical Diagnostics

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