Diagnostics company SphingoTec GmbH ("sphingotec") announced today the results of a working group meeting of clinical experts that discussed the utility of sphingotec's diagnostic solutions for acute and critical care in supporting the triage, diagnosis, and management of severely ill COVID-19 patients.
The experts representing European medical centers agreed that novel biomarkers are required for triaging and monitoring of these patients to optimally make use of the available medical resources and improve outcomes.
Diagnostic tests for sphingotec's organ-specific biomarkers for monitoring the endothelial and kidney function are currently investigated on-site in COVID-19 patients in hospitals in Germany, Switzerland, United Kingdom, France, and Italy.
Serial measurements of sphingotec's real-time endothelial function biomarker bio-ADM, kidney function biomarker penKid, and cardiac depressant factor DPP3 were performed in these centers to investigate their utility in the management of COVID-19 patients.
In a working meeting, the investigators discussed their initial findings to develop a consensus on the diagnostic needs of severely ill Covid-19 patients and how sphingotec's biomarkers can address these needs.
Prof. Thorsten Brenner (Essen University Hospital/Essen, Germany) commented: "To identify high-risk patients, we need early and specific markers for organ failure to be measured already in the emergency departments.
PenKid is a very promising biomarker that we are currently investigating for the triage and the monitoring of organ support therapies of COVID-19 patients with impaired kidney function."
Previously gathered evidence confirmed the central role of bioactive Adrenomedullin and endothelial function in sepsis patients.
First feedback on the biomarker bio-ADM in severe COVID-19 describes a strong correlation between high bio-ADM blood levels and the severity of the disease and the need for organ support which can assist in more accurate and objective risk stratification.
Further investigations with DPP3, penKid, and bio-ADM are ongoing in countries strongly affected by the COVID-19 pandemic, such as France, Italy, and the United Kingdom as well as in the United States and Asia.
The main objective is to confirm the utility of sphingotec's biomarkers in the management of COVID-19 patients.
Dr. Marlies Ostermann, MD, Ph.D. (Guy's & St Thomas' Hospital/London, United Kingdom) commented: "There is an urgent need to assess and monitor organ function of COVID-19 patients in real-time.
After a first positive evaluation of these novel biomarkers, we have decided to further investigate their use in clinical practice.
Especially in the intensive care units, we need biomarkers for the monitoring of organ support therapies. This information will also enable us to develop strategies for individualized management of this high-risk group."
The rapidly evolving COVID-19 pandemic has challenged health systems worldwide, with about 5% of patients requiring admission to intensive care units (ICU).
Among the main complications that include respiratory, cardiovascular, and kidney diseases, an emerging body of evidence shows that endothelial function plays a central role in severe COVID-19 patients.
Previous clinical data from more than 22,000 patients demonstrate that high bio-ADM levels independently from inflammation and co-morbidities indicate distortions in the endothelial barrier function, the inner cell sheet of blood vessels.
Loss of this barrier function is considered a key driver in the development of hypotension and subsequent septic shock with loss of organ perfusion in sepsis patients.
According to a Chinese Study in Wuhan, among the non-surviving COVID-19 patients, sepsis was present in all cases.
Another frequently occurring complication in COVID-19 patients is the loss of kidney function. Proenkephalin (penKid) has been demonstrated to be the most accurate surrogate marker for true glomerular filtration rate in patients with renal impairment, without being biased by co-morbidities.
DPP3, sphingotec's novel biomarker for hemodynamic instability and cardiac depression, is a major cause of short-term organ failure when released in an uncontrolled manner into the bloodstream.
Previously published data has shown that high blood levels of DPP3 strongly predict poor outcome in patients with cardiogenic shock.
To support the critical care community in the management of acute care patients, including COVID-19 patients, we have made available rapid tests for our biomarkers penKid®, bio-ADM®, and DPP3 on our whole-blood Nexus IB10 point-of-care platform."
Dr. Andreas Bergmann, Founder and CEO, Sphingotec GmbH
The novel biomarker tests complement a wide-range of assays for acute care settings that are already available on sphingotec's widely used Nexus IB10 point-of-care platform that can be flexibly deployed in the laboratory as well as near-patient settings such as emergency departments and intensive care units.