DGAP-Media / 2020-07-22 / 10:00
? _Endothelial dysfunction is driving pathophysiological processes such as
congestion in heart failure, shock in sepsis, and lung dysfunction in
COVID-19 _
? _Bioactive Adrenomedullin (bio-ADM(R)) is a proprietary biomarker for
real-time assessment of endothelial function in acute and critical care
settings. _
? _High blood levels of bio-ADM(R) have been shown to predict septic
shock, to diagnose residual congestion in heart failure, and the need for
organ support in critically ill patients, including COVID-19 _
? _IB10 sphingotest(R) bio-ADM(R) runs on SphingoTec's automated Nexus
IB10 point-of-care platform and quantitatively measures levels of
bio-ADM(R) directly in blood samples _
*Hennigsdorf/Berlin, Germany, July 22, 2020* - Diagnostics company
SphingoTec GmbH ("SphingoTec") today announced the launch of its IB10
sphingotest(R) bio-ADM(R), a CE-IVD-marked point-of-care test to
quantitatively determine blood levels of Bioactive Adrenomedullin
(bio-ADM(R)). Blood levels of bio-ADM(R) reflect in real-time the functional
status of the endothelium, the inner cell sheet of blood vessels. The test
is made available on the company's rapid point-of-care platform Nexus IB10
that uses whole blood samples without any pre-processing, requires less than
three minutes hands-on-time, and delivers results after 20 minutes. Nexus
IB10 can be flexibly deployed in laboratories or near-patient settings such
as intensive care units (ICUs) and Emergency Departments (EDs).
In numerous studies on more than 22,000 patients admitted to ICUs and EDs,
bio-ADM(R) has been shown to predict distortions of the inner cell sheet of
blood vessels, the endothelium (1). Failure of the endothelial function has
been demonstrated to precede edema and the life-threatening blood pressure
drop that causes shock and multiorgan failure e.g. in patients with sepsis
at ICUs and EDs (2-3). In heart failure patients, bio-ADM(R) blood-levels
reliably and objectively reflect tissue congestion and residual congestion
(4). Recent data show that elevated blood levels of this functional
biomarker also identifies patients in the general ICU patient population who
require immediate life-saving therapeutic interventions (5). In ICU patients
with severe COVID-19, endothelial dysfunction has been identified to play a
crucial role in the disease progression, thus providing a rationale to
monitor bio-ADM(R) to guide the therapy stabilizing the endothelium (6).
Dr. Andreas Bergmann, CEO and founder of SphingoTec commented: "The
endothelial function plays a key role in a large number of critical care
conditions, such as sepsis, septic shock, acute heart failure, and COVID-19.
A distortion in the endothelial function predicts the patient's progression
to a critical stage. Therefore, bio-ADM(R) screening can identify high-risk
patients who require early life-saving therapeutic intervention. With the
launch of this rapid test for bio-ADM(R) on our widely established Nexus
IB10 immunoassay platform, we aim to support earlier treatment decisions and
improve outcomes of acute care patients."
The IB10 sphingotest(R) bio-ADM(R) assay is commercialized in Europe and
other regions that accept CE-IVD certification through SphingoTec's network
of distribution partners for the Nexus IB10 platform, together with a broad
menu of standard tests for acute and critical care.
_###_
_References: _
_(1) Geven (2018): Vascular Effects of Adrenomedullin and the
anti-Adrenomedullin Antibody Adrecizumab in Sepsis. Shock. doi:
_1097/SHK.0000000000001103 [1]
_(2) Mebazaa (2018): Circulating adrenomedullin estimates survival and
reversibility of organ failure in sepsis: the prospective observational
multinational Adrenomedullin and Outcome in Sepsis and Septic Shock
(AdrenOSS-1) study. doi:_10.1186/s13054-018-2243-2 [1]
_(3) Caironi (2017): Circulating biologically active adrenomedullin
(bio-ADM) predicts hemodynamic support requirement and mortality During
Sepsis. Chest. doi: 10.1016/j.chest.2017.03.035. _
_(4) ter Maaten (2019): Bio-adrenomedullin as a marker of congestion in
patients with new-onset and worsening heart failure, Eur J Heart Fail.
doi:10.1002/ejhf.1437(5) _
_Lemasle (2020): Bioactive Adrenomedullin, Organ Support Therapies, and
Survival in the Critically Ill: Results from the French and European Outcome
Registry in ICU Study, Crit. Care. Med, _doi: 10.1097/CCM.0000000000004044
[2]
_(6) Varga (2020): Endothelial cell infection and endotheliitis in COVID-19,
Lancet, _
https://doi.org/10.1016/S0140-6736(20)30937-5
*About SphingoTec *
SphingoTec GmbH ("SphingoTec"; Hennigsdorf near 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 sepsis, acute heart failure, circulatory shock,
and acute kidney injury in order to support patient management and provide
guidance for treatment strategies. SphingoTec's proprietary biomarker
portfolio includes Bioactive Adrenomedullin (bio-ADM(R)), a unique biomarker
for real-time assessment of endothelial function in conditions like sepsis
or congestive heart failure, Proenkephalin (penKid(R)), a unique biomarker
for real-time assessment of kidney function, and Dipeptidyl Peptidase 3
(DPP3), a unique biomarker for cardiac depression. In addition, SphingoTec
develops a portfolio of novel biomarkers, which predict the risks of
developing obesity, breast cancer and cardiovascular diseases. IVD tests for
SphingoTec's proprietary biomarkers are made available as sphingotest(R)
microtiterplate tests as well as point-of-care tests on the Nexus IB10
immunoassay platform by SphingoTec's subsidiary Nexus Dx Inc. (San Diego,
CA, USA) alongside a broad menu of established and commonly used tests for
acute and critical care.
*About Nexus Dx Inc. and the IB10 Platform *
Nexus Dx Inc., a wholly-owned subsidiary of SphingoTec, headquartered in San
Diego, CA, USA, is a global provider of a near patient testing system and
advanced diagnostic solution. The company is improving patient care by
providing the medical community with rapid and reliable information at the
point of care (POC), delivering patient information when and where it is
needed most. The company has invested over $160m to develop and market the
IB10 analyzer system which, without the need for sample preparation,
automatically separates plasma from whole blood with subsequent reliable and
quantitative detection of biomarkers in the plasma by means of antibodies.
With a hands-on-time of less than 3 minutes the easy-to-use system provides
in only 20 minutes test results for biomarkers that are crucial in the
management of critical care patients. The portfolio of IB10 assays includes
tests for established critical care parameters such as Procalcitonin,
Troponin I, CK-MB, Myoglobin, NT-proBNP, and D-Dimer as well as tests for
SphingoTec's proprietary biomarkers such as DPP3, an assay for Dipeptidyl
Peptidase 3, a unique and proprietary biomarker for cardiac depression,
Proenkephalin (penKid(R)), a unique and proprietary biomarker for real-time
assessment of kidney function and the IB10 assay for bioactive
Adrenomedullin (bio-ADM(R)), a unique and proprietary biomarker for
endothelial function.
*About bio-ADM(R)*
sphingotest(R) bio-ADM(R) measures blood levels of bioactive adrenomedullin
(bio-ADM(R)), a hormone maintaining endothelial function. The endothelium
contributes to blood pressure and separates blood from the surrounding
tissue. Elevated blood levels of bio-ADM(R) predict blood pressure break
down and leaky vessels resulting in oedema. Imbalanced endothelial function
is the major cause of shock ultimately resulting in organ dysfunction and
death. Early identification of an imbalance in endothelial function allows
guidance of vasopressor and diuretic therapy in critically ill patients to
improve outcomes.
*Contact *
SphingoTec GmbH
Ruxandra Lenz
Sr. Manager Marketing and Communications
Neuendorfstr. 15 A
16761 Hennigsdorf
Germany
Tel. +49-3302-20565-0
press@sphingotec.de
www.sphingotec.com
End of Media Release
Issuer: SphingoTec GmbH
Key word(s): Health
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