- Data from more than 2,000 patients enrolled in the FROG-ICU study demonstrate that high levels of bioactive adrenomedullin (bio-ADM®) predict the need for organ support, ionotropes, and vasopressors in the general patient population at admission to the intensive care unit (ICU).
- bio-ADM® screening of patients admitted for septic or non-septic reasons supports stratification of risk patients that need immediate therapeutic intervention due to an elevated risk of organ failure.
- sphingotec will launch a CE-marked IVD point-of-care assay for bio-ADM® rapid testing on its proprietary Nexus IB10 immunoassay platform in mid-2020.
Hennigsdorf/Berlin, Germany, December 23, 2019 - Diagnostics company SphingoTec GmbH ("sphingotec", Hennigsdorf, Germany) today announced a publication in Critical Care1 with data on 2,000 ICU patients demonstrating that sphingotec‘s proprietary biomarker bio-ADM® (Bioactive Adrenomedullin) not only identifies high-risk patients for septic shock at admission but also identifies patients in the general ICU patient population who require immediate life-saving therapeutic intervention.
In an observational ancillary study to the FROG-ICU study, high blood levels of bio-ADM® at admission to the ICU were an early predictor of the requirement for organ support and treatment with ionotropes and vasopressors. Elevated bio-ADM® blood levels were also significantly associated with a prolonged length of ICU stay and fatal outcomes within 28 days post-admission, whereas low levels of bio-ADM® at admission were associated with positive outcomes.
This study is the largest published investigation on bio-ADM® in a patient cohort of which about 25% of patients suffered from sepsis and 75% of patients had conditions that were not sepsis-related. According to principal investigator Prof. Alexandre Mebazaa (Hôpital Lariboisière, Paris, France), the results demonstrate that bio-ADM® is not only a biomarker indicating impaired endothelial function in patients with septic shock as previously shown2, but also identifies further ICU patients who require rapid therapeutic intervention at admission due to distortion in endothelial function, which is independently associated with malperfusion of organs.
Previous data from more than 20,000 patients provide evidence, that high blood levels of bio-ADM® reflect impaired endothelial function independently from inflammation and other co-morbidities. High bio-ADM® blood levels indicate distortions in the barrier function of the endothelium before the patients progress to a critical stage. Failure of endothelial function has been demonstrated to precede the life-threatening blood pressure drop that causes shock and multiorgan failure e.g. in patients with sepsis at ICUs and in emergency departments (EDs) 2-3. Each year, 6 million people die from sepsis, one of the largest contributors to global disease burden causing $24 billion in direct annual costs to the U.S. healthcare system alone. As elevated bio-ADM® blood levels precede septic shock, bio-ADM® screening can identify risk patients who require early life-saving therapeutic intervention.
“The new study results add data to the broad body of existing evidence that our biomarker bio-ADM® can reliably support critical care physicians in identifying high-risk patients when they first present at the ICU,” 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 platform by mid-2020. We are convinced that this rapid test for bio-ADM® will support earlier treatment decisions and improve outcomes of patients at ICUs and emergency departments.”
- Lemasle L. et al., (2018): 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: 1097/CCM.0000000000004044
- Mebazaa A. et , (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
- Geven C. et al., (2018): Vascular Effects of Adrenomedullin and the anti-Adrenomedullin Antibody Adrecizumab in Sepsis. Shock. doi: 1097/SHK.0000000000001103
As a marker of endothelial function, bioactive Adrenomedullin (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. Data from more than 20,000 patients provide evidence, that high plasma levels of bio-ADM® reflect impaired endothelial function independently from inflammation and other co-morbidities. High bio-ADM® plasma levels indicate distortions in the barrier function of the endothelium before the patients progress to a critical stage. Failure of endothelial function has been demonstrated to precede the life-threatening blood pressure drop that causes shock and multiorgan failure e.g. in patients with sepsis at ICUs and in emergency departments (EDs). As elevated bio-ADM® plasma levels precede septic shock, bio-ADM® screening can identify risk patients who require early life-saving therapeutic intervention.
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 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. The IB10 assay for bioactive Adrenomedullin (bio-ADM®), a unique and proprietary biomarker for endothelial function and the assay for Proenkephalin (penKid®), a unique and proprietary biomarker for real-time assessment of kidney function, will be launched later in 2020.