Sepsis, septic shock, and acute failure of vital organs such as heart and kidney, are diagnostically underserved medical conditions in critical care settings. Based on a deep understanding of the disease biology, sphingotec has developed novel biomarkers to tackle these unmet needs through diagnostic solutions that allow early identification and monitoring of critically ill patients. sphingotec's near-term pipeline of novel assays on the Nexus IB10 platform includes:

• IB10 sphingotest(R) DPP3 launched in August 2019 is the first CE-IVD point-of-care biomarker test able to quantify DPP3 blood-plasma levels, a novel and unique biomarker for assessing cardio-renal pathway disruptions leading to short-term organ dysfunction [1, 2]. DPP3 is at the core of a novel disease mechanism that has a causal role in cardiac and renal dysfunction.

• IB10 sphingotest(R) penKid(R), to be launched in early 2020 as a CE-IVD test, is the first point-of-care assay for Proenkephalin, a unique and proprietary biomarker for real-time assessment of kidney function. Previous studies on more than 30,000 critically ill patients admitted to emergency departments (EDs) or intensive care units (ICUs) with congestive heart failure [3] or sepsis [4] demonstrated that Proenkephalin levels change dynamically with the actual kidney function independently from comorbidities or inflammation [5]. The biomarker allows monitoring of renal function in real-time and facilitates earlier detection and more precise monitoring of acute kidney injury than the current standard-of-care.

• IB10 sphingotest(R) bio-ADM(R) to be launched in mid-2020, is a first point-of-care assay for bioactive Adrenomedullin, a unique biomarker for real-time assessment of endothelial function [6]. Data from more than 20,000 patients confirm that measuring bio-ADM(R) levels adds value to clinical decision making in ICUs and EDs. Increased blood levels of bioactive Adrenomedullin have been demonstrated to precede endothelial dysfunction, vascular leakage subsequent systemic vasodilation and shock in sepsis [7]. Furthermore, it has been shown that elevated levels of bioactive Adrenomedullin indicate the loss of endothelial function leading to congestion in heart failure [8]. IB10 sphingotest(R) bio-ADM(R) not only supports earlier clinical interventions but also the monitoring of treatment success.

The Nexus IB10 point-of-care technology provides test results on whole blood sample in only 20 minutes and can be flexibly deployed in emergency departments, intensive care units, and any laboratory setting. In addition to the increasing menu of assays for proprietary biomarkers, the platform features a broad menu of 8 rapid tests for acute care settings including parameters such as the Troponin-I, NT-proBNP, and D-Dimer. Following the acquisition of Nexus Dx Inc., San Diego, USA, in 2018 from the Korean manufacturer Samsung, sphingotec markets the Nexus IB10 point-of-care platform through its continuously expanding distribution network.

Visit sphingotec at Medica 2019

sphingotec showcases its Nexus IB10 instrument and test portfolio as well as its proprietary biomarkers for acute care conditions at Medica 2019 and welcomes healthcare professionals as well as distributors and diagnostics and pharmaceutical industry representatives interested in partnering at its booth G52 in hall 3.

References

[1] Takagi et. al. (2019) Circulating dipeptidyl-peptidase 3 and alteration in hemodynamics in cardiogenic shock: Results from the OptimaCC Trial, European Journal of Heart Failure
[2] Deniau et. al. (2019) Circulating dipeptidyl peptidase-3 is a myocardial depressant factor: DPP3 inhibition rapidly and sustainably improves hemodynamics, European Journal of Heart Failure
[3] Siong Chan (2018) Proenkephalin in heart failure
[4] Hollinger et. al. (2018) Proenkephalin A 119-159 (Penkid) Is an Early Biomarker of Septic Acute Kidney Injury: The Press Release Kidney in Sepsis and Septic Shock (Kid-SSS) Study
[5] Beunders et. al. (2017) Proenkephalin (PENK) as a novel biomarker for kidney function.
[6] Geven et. al. (2018) Geven 2018 Vascular effects of adrenomedullin and the anti-adrenomedullin antibody Adrecizumab in sepsis
[7] Mebazaa et. al. (2018) Circulating adrenomedullin estimates survival and reversibility of organ failure in sepsis: the prospective observational multinational Adrenomedullin and Outcome in Sepsis and Septic Shock-1
(AdrenOSS-1) study
[8] ter Maaten et. al.(2019) Bio-adrenomedullin as a marker of congestion in patients with new-onset and worsening heart failure

About sphingotec
SphingoTec GmbH ('sphingotec' Hennigsdorf by Berlin, Germany) develops and markets innovative in vitro diagnostic IVD tests for novel and proprietary biomarkers for the diagnosis, prediction and monitoring of acute medical conditions, such as acute heart failure, circulatory shock, and acute kidney injury in order to support patient management and provide guidance for treatment strategies. sphingotec's assay portfolio includes sphingotest(R) bio-ADM(R) the assay for bioactive adrenomedullin, a unique biomarker for real-time assessment of vascular integrity in conditions like sepsis or congestive heart failure, sphingotest(R) penKid(R), the assay for proenkephalin, a unique biomarker for real-time assessment of kidney function and sphingotest(R) DPP3, an assay for Dipeptidyl Peptidase 3, a unique biomarker for signaling pathway disruptions leading to acute organ dysfunction. Along with the Nexus IB10 POC platform by its subsidiary Nexus Dx Inc. (San Diego, CA, USA) acquired from Samsung in 2018, sphingotec markets a standard marker portfolio for acute care. In addition, sphingotec developed a portfolio of novel biomarkers, which predict the risks of obesity, breast cancer and cardiovascular diseases.

Contact:
Ruxandra Lenz
PR and Market Communications Manager
+ 49 3302 20565 34
press@sphingotec.de

SOURCE: SphingoTec GmbH