- Data from more than 1,200 patients of the PROTECT study demonstrate that high levels of the endothelial function biomarker bio-ADMÂ® (bioactive Adrenomedullin) indicate residual congestion of heart failure patients.
- Endothelial dysfunction, indicated by high bio-ADMÂ® 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-ADMÂ® 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 demonstrating that its proprietary endothelial function biomarker bio-ADM® 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® 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® 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® 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® plasma levels specifically indicate endothelial function independent of inflammation and other co-morbidities[2-3]. High bio-ADM® 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® 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® 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® 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® will be launched mid-2020. The IB10 sphingotest® bio-ADM® 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®, 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.
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 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
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® bio-ADM® the assay for bioactive adrenomedullin, a unique biomarker for real-time assessment of endothelial function in conditions like sepsis or congestive heart failure, sphingotest® penKid®, the assay for proenkephalin, a unique biomarker for real-time assessment of kidney function and IB10 sphingotest® 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.
As a marker of endothelial function, bio-ADM® 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.