SphingoTec Launches POC Test for bio-ADM

Diagnostics company SphingoTec GmbH announced the launch of its IB10 sphingotest bio-ADM, a CE-IVD-marked point-of-care test to quantitatively determine blood levels of Bioactive Adrenomedullin (bio-ADM). Blood levels of bio-ADM reflect in real-time the functional status of the endothelium, the inner cell sheet of blood vessels. The test is made available on the company`s rapid point-of-care platform Nexus IB10 that uses whole blood samples without any pre-processing, requires less than three minutes hands-on-time, and delivers results after 20 minutes. Nexus IB10 can be flexibly deployed in laboratories or near-patient settings such as intensive care units (ICUs) and Emergency Departments (EDs).

In numerous studies on more than 22,000 patients admitted to ICUs and EDs, bio-ADM has been shown to predict distortions of the inner cell sheet of blood vessels, the endothelium.¹ Failure of the endothelial function has been demonstrated to precede edema and the life-threatening blood pressure drop that causes shock and multiorgan failure e.g. in patients with sepsis at ICUs and EDs.^2,3 In heart failure patients, bio-ADM blood-levels reliably and objectively reflect tissue congestion and residual congestion.⁴ Recent data show that elevated blood levels of this functional biomarker also identifies patients in the general ICU patient population who require immediate life-saving therapeutic interventions.⁵ In ICU patients with severe COVID-19, endothelial dysfunction has been identified to play a crucial role in the disease progression, thus providing a rationale to monitor bio-ADM to guide the therapy stabilizing the endothelium.⁶

Dr. Andreas Bergmann, CEO and founder of SphingoTec, commented, “The endothelial function plays a key role in a large number of critical care conditions, such as sepsis, septic shock, acute heart failure, and COVID-19. A distortion in the endothelial function predicts the patient’s progression to a critical stage. Therefore, bio-ADM screening can identify high-risk patients who require early life-saving therapeutic intervention. With the launch of this rapid test for bio-ADM on our widely established Nexus IB10 immunoassay platform, we aim to support earlier treatment decisions and improve outcomes of acute care patients.”

The IB10 sphingotest bio-ADM assay is commercialized in Europe and other regions that accept CE-IVD certification through SphingoTec’s network of distribution partners for the Nexus IB10 platform, together with a broad menu of standard tests for acute and critical care.

References
¹ Geven (2018): Vascular Effects of Adrenomedullin and the anti-Adrenomedullin Antibody Adrecizumab in Sepsis. Shock. doi: 1097/SHK.0000000000001103
² Mebazaa (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
³ Caironi (2017): Circulating biologically active adrenomedullin (bio-ADM) predicts hemodynamic support requirement and mortality During Sepsis. Chest. doi: 10.1016/j.chest.2017.03.035.
⁴ ter Maaten (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
⁵ Lemasle (2020): 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: 10.1097/CCM.0000000000004044
⁶ Varga (2020): Endothelial cell infection and endotheliitis in COVID-19, Lancet, https://doi.org/10.1016/S0140-6736(20)30937-5