Diagnostics company SphingoTec GmbH ("sphingotec", Hennigsdorf, Germany) today announced a publication in Critical Care 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 shown, 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). 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. 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."
Dr. Andreas Bergmann, founder and CEO of sphingotec
Lemasle, L., et al. (2019) Bioactive Adrenomedullin, Organ Support Therapies, and Survival in the Critically Ill: Results from the French and European Outcome Registry in ICU Study. Critical Care Medicine. doi.org/10.1097/CCM.0000000000004044.