DGAP-Media / 2019-12-16 / 10:30
? _Data from more than 1,200 patients of the PROTECT study demonstrate
that high levels of the endothelial function biomarker bio-ADM__(R)_
_(bioactive Adrenomedullin) indicate residual congestion of heart failure
patients._
? _Endothelial dysfunction, indicated by high bio-ADM__(R)_ _levels, leads
to fluid leakage from blood vessels and ultimately resulting in tissue
congestion._
? _With 25% of heart failure patients being readmitted to hospitals due to
acute decompensation, bio-ADM__(R)_ _is the only biomarker whose
measurements can guide therapy with diuretics and support more informed
decisions on discharging patients from hospitals._
*Hennigsdorf/Berlin, Germany, December 16, 2019 *- Diagnostics company
SphingoTec GmbH (sphingotec) today announced the publication of new study
results in the European Journal of Heart Failure[1] demonstrating that its
proprietary endothelial function biomarker bio-ADM_(R)_ reliably diagnoses
tissue congestion and residual congestion. Residual congestion is a
critical, yet highly under-diagnosed condition in heart failure patients
often leading to complications after the patient was discharged from the
hospital.
In more than 1,200 patients enrolled in the PROTECT study, high bio-ADM_(R)_
plasma levels indicated insufficient response to diuretics and a
substantially higher risk for short-therm rehospitalization and mortality.
According to the principal investigator, Dr. Adrian Voors (University
Hospital Groningen, The Netherlands), the study data confirm bio-ADM_(R)_ as
a biomarker for tissue congestion that complements BNP as a biomarker for
cardiac wall stress.
Specifically, the PROTECT study results show that bio-ADM_(R)_ is the only
biomarker that allows identification of residual congestion and the need for
continued therapeutic intervention with diuretics.
About 95% of patients with acute heart failure show fluid overload and
tissue congestion with lung edema as the most fatal complication. Previous
clinical data from more than 20,000 patients have demonstrated that
bio-ADM_(R)_ plasma levels specifically indicate endothelial function
independent of inflammation and other co-morbidities[2-3]. High bio-ADM_(R)_
levels indicate distortions in the barrier function of the endothelium
causing fluid leakage into tissue. Today, 25% of acute heart failure
patients discharged from hospitals are readmitted within 30 days, mostly
because of residual congestion with subclinical manifestation at the time of
discharge. By measuring the levels of bio-ADM_(R)_ in blood it becomes
possible to assess congestion status and identify patients with residual
congestion that are in need of further intervention measures. This may
considerably reduce the risk of complications after the patient is
discharged and decrease the need for readmission to the hospital. Hence, a
diagnostic test for bio-ADM_(R)_ that indicates subclinical residual
congestion may improve the quality of care and patient outcomes while
reducing costs associated with readmission.
"These study results confirm that bio-ADM_(R)_ is a biomarker for
endothelial function, which allows physicians to identify patients with
residual congestion," said Dr. Andreas Bergmann, founder and CEO of
sphingotec. "By providing diagnostic tools that support a more informed
management of heart failure patients we achieve another milestone in our
strategy to fight mortality in critically ill patients".
sphingotec develops novel biomarkers for the diagnosis of critical care
conditions and makes them available as rapid tests on its point-of-care
immunoassay analyzer, Nexus IB10. The CE-IVD-marked IB10 assay for
bio-ADM_(R)_ will be launched mid-2020. The IB10 sphingotest_(R)_
bio-ADM_(R)_ test complements a recently introduced IB10 assay for DPP3, a
protein whose elevated blood levels are a major cause for loss of heart and
kidney function. Future launches of Nexus IB10 tests also include in early
2020 the assay for penkid_(R)_, a novel biomarker for the real-time
assessment of kidney function. In addition to the assays for sphingotec's
properitary biomarkers, the IB10 platfrom features a broad menu of routine
tests for critical care and other conditions that benefit from rapid testing
in near-patient settings.
###
*References*
1) Pandhi (2019): The clinical value of pre-discharge bio-adrenomedullin
as a marker of residual congestion and high risk of heart failure hospital
readmission. Eur J Heart Fail. doi: 10.1002/ejhf.1693
2) Voors et a. (2018) Adrenomedullin in heart failure pathophysiology and
therapeutic application. Eur J Heart Fail. doi:10.1002/ejhf.1366
3) Ter Maaten [1] J. et al., (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
*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 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 endothelial function 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 IB10 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 portfolio of established and novel biomarkers
for acute care. In addition, sphingotec developed a portfolio of novel
biomarkers, which predict the risks of obesity, breast cancer and
cardiovascular diseases.
*About bio-ADM*_(R)_
As a marker of endothelial function, bio-ADM_(R)_ enables both prediction of
circulatory shock before blood pressure decline, e.g. in septic patients,
and diagnosis of residual congestion in acute heart failure patients.
*Contact *
SphingoTec GmbH
Ruxandra Lenz
PR & Market Communications Manager
Neuendorfstr. 15A
16761 Hennigsdorf
Germany
Tel. +49-3302-20565-34
press@sphingotec.de [2]
www.sphingotec.com
End of Media Release
Issuer: SphingoTec GmbH
Key word(s): Health
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