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Sphingotec's endothelial function biomarker bio-ADM® improves risk stratification of sepsis patients at ICUs

March 05, 2020

  • Monitoring of both, lactate and bio-ADM®, in sepsis patients allows early identification of patients that require immediate intervention at admission to the ICU.
  • Sphingotec is set to launch a point-of-care bio-ADM® assay running on its proprietary automated Nexus IB10 instrument in mid-2020.
Hennigsdorf/Berlin, Germany, March 5, 2020 - Diagnostics company SphingoTec GmbH ("sphingotec", Hennigsdorf Germany) today reported on new data on the utility of endothelial function biomarker bioactive Adrenomedullin (bio-ADM®). The data show that bio-ADM® allows identification of sepsis patients who are at high risk of fatal outcomes despite low or decreasing levels of the routinely monitored parameter lactate. Lactate, a parameter that identifies reduced blood oxygenation of tissue, is routinely used as a reference in the diagnosis of septic shock. However, lactate is rather unspecific to sepsis and insensitive. This limitation can be overcome by monitoring, in addition to lactate, the blood levels of bio-ADM®, a biomarker that can reliably detect blood vessel leakage, one of the main causes of septic shock.

According to recent findings published in Critical Care1, data from over 500 sepsis patients enrolled in the AdrenOSS-1 study demonstrate the added value of bio-ADM® to lactate monitoring. The AdrenOSS-1 study investigators could show that even though normalizing lactate levels indicate a significantly decreased risk of mortality, an additional measurement of bio-ADM® blood levels can help identify those patients that are still at risk of fatal outcomes despite their lower lactate levels. Among septic patients with decreasing lactate, high bio-ADM® levels identified patients who had a 4-time higher mortality risk than patients with low bio-ADM levels. According to the authors of the study, measurement of bio-ADM® on top of lactate may help refine risk stratification and thus guide resuscitation during sepsis.

Lactate has been used for more than 30 years to monitor organ hypoperfusion in sepsis patients. However, lactate blood levels are influenced by many other physiological and pathological processes. Clinical data from more than 22,000 patients demonstrate that high bio-ADM® levels independently from inflammation and co-morbidities indicate distortions in the barrier function of the inner cell sheet of blood vessels, the endothelium. Loss of this barrier function is considered a key driver in the development of hypotension and eventually septic shock with loss of organ perfusion in sepsis patients2. According to sphingotec's research, bio-ADM® can explain about 60% of the fatal outcomes in sepsis.

"Our biomarker bio-ADM® can reliably support acute care physicians in identifying high-risk sepsis patients" said Dr. Andreas Bergmann, founder and CEO of sphingotec. "We are set to launch the fully automated CE-IVD-marked point-of-care bio-ADM® assay on our widely established Nexus IB10 immunoassay instrument by mid-2020. We are convinced that this rapid test for bio-ADM® will support earlier treatment decisions and thereby will assist clinical decisions that may improve the outcomes of patients at ICUs and emergency departments."
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References

1. Benjamin G. Chousterman et al (2020): Added value of serial bio-adrenomedullin measurement in addition to lactate for the prognosis of septic patients admitted to ICU,. doi:10.1186/s13054-020-2794-x

2. 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, Crit Care, doi: 10.1186/s13054-018-2243-2

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®), a unique biomarker for real-time assessment of endothelial function in conditions like sepsis or congestive heart failure, Proenkephalin (penKid®), a unique biomarker for real-time assessment of kidney function, and Dipeptidyl Peptidase 3 (DPP3), a unique biomarker for cardio-renal pathway disruptions leading to acute organ dysfunction. 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® 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 IB10 tests for established biomarkers for acute and critical care.

About bio-ADM®

sphingotest® bio-ADM® measures blood levels of bioactive adrenomedullin (bio-ADM®), a hormone maintaining endothelial function. The endothelium contributes to blood pressure and separates blood from the surrounding tissue. Elevated blood levels of bio-ADM® 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.

Septic shock

Septic Shock is defined as a life-threatening organ dysfunction due to dysregulated host response to a proven or suspected infection which leads to a decline of Mean Arterial Pressure (MAP) < 65 mmHg, which is refractory to fluid resuscitation and requires vasopressors. Refractoriness to fluid resuscitation is defined as a lack of response to the administration of 30 mL of fluid per kilogram of body weight or is determined according to a clinician's assessment of inadequate hemodynamic results.

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 cardio-renal pathway disruptions leading to acute organ dysfunction, and Proenkephalin (penKid®), a unique and proprietary biomarker for real-time assessment of kidney function. An IB10 assay for bioactive Adrenomedullin (bio-ADM®), a unique and proprietary biomarker for endothelial function is expected to be launched later in 2020.

sphingotec GmbH

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