HENNIGSDORF, Germany, March 14, 2019 — German diagnostics company sphingotec GmbH (Hennigsdorf) announced that leaders in critical care nephrology have confirmed clinical utility of the company’s glomerular filtration biomarker penKid® for early diagnosis, exclusion and monitoring of acute kidney injury (AKI). Data from prospective, observational studies presented at the 24th International Conference on Advances in Critical Care Nephrology (AKI & CRRT; 26 Feb-1 March, 2019) in San Diego demonstrate that penKid® is suitable to guide treatment decisions at ICUs and EDs.
At the AKI & CRRT conference, Prof. Matthieu Legrand (Critical Care Medicine & Burn Unit at Hôpital Lariboisière Paris, France) reported results from a sub-study of the PRONOburn cohort that enrolled 113 burn patients admitted to burn intensive care units (ICUs). High penKid® levels at admission (> 80 pmol/L) were sufficient to predict acute kidney injury (AKI) even when other indicators such as the SOFA score gave no sufficient information (p<0.001). In sepsis patients, enrolled in the FROG-ICU and AdrenOSS-1 cohorts, including more than 1,100 patients, elevated penKid® plasma levels identified sub-AKI while creatinine values remained normal (1 out of 4 patients). Sub-AKI was associated with worse outcomes.
Peer-reviewed data  on the biological variation of four AKI biomarker tests in patients with stable heart disease presented by Dr. Alan Wu (UCLA, San Francisco) demonstrated that penKid® is best suited for early diagnosis of renal insufficiency in clinical practice. Data from 85 iniduals enrolled in the Valsartan Heart Failure Trial (Val-HeFT) support that penKid® testing would be of value in managing patients in EDs and ICUs. Commenting on the results, key opinion leaders suggested to add penKid® measurements to AKI routine testing for triaging and monitoring, which today only allows delayed information using available biomarkers.
“The biovariability of a biomarker is a key attribute, but not tested for many of the novel kidney markers. penKid® shows a low variability – allowing information with the first measurement,” said Dr. Wu. “penKid® has a huge value to rule out patients in EDs,” confirmed Prof. Salvatore Di Somma, Head of Emergency Medicine Sant’Andrea Hospital, Rome, Italy. sphingotec showed data from pilot routine testing, which has already begun at undisclosed ICUs and EDs in Germany. Study leaders confirmed that triaging will be supported by penKid® information, because the marker can rule out AKI as BNP rules out Heart Failure. David Bruno, Director of the University of Maryland Transplant Surgery Program announced starting tests with penKid® to predict graft function recovery in kidney transplantation.
Plasma penKid® is a surrogate marker for disturbed renal glomerular filtration rate (GFR), which reflects kidney function. Previous studies on more than 30,000 critically ill patients admitted to EDs or ICUs with congestive heart failure  or sepsis  demonstrated that penKid® levels change dynamically with the actual kidney function independently from comorbidities or inflammation . penKid® levels rise up to 48 hours prior to those of creatinine preceding kidney injury (AKI), which affects about 25 percent of patients admitted to ICUs.
By the end of H1/2019, sphingotec will launch a penKid® point-of-care (POC) test on its fully automated Nexus IB10 POC testing platform for use in EDs and ICUs. The platform allows measurement of up to five critical care biomarker tests in one run within 20 minutes without any sample preparation.
 Wu, A., Anand, I. (2018) Biological variation of plasma proenkephalin: data from a stable heart failure cohort.
 Chan S. et al. (2018) Proenkephalin in Heart Failure; Kanagala P. et al.: Proenkephalin and prognosis in heart failure with preserved ejection fraction: a GREAT network study.
 Hollinger et al. (2018) Proenkephalin A 119-159 (Penkid) Is an Early Biomarker of Septic Acute Kidney Injury: The Kidney in Sepsis and Septic Shock (Kid-SSS) Study.
 Beunders, R. et al. (2017) Proenkephalin (PENK) as a novel biomarker for kidney function.
About sphingotec GmbH: sphingotec GmbH (Hennigsdorf, Germany) is developing and marketing innovative biomarkers such as penKid® and bio-ADM® for prediction, diagnosis and therapy monitoring of AKI, congestive heart failure and septic shock, as well as the Nexus IB10 POC testing immunoassay platform acquired from Samsung-subsidiary Nexus Dx Inc. in May 2018. The company, founded by Dr. Andreas Bergmann in 2002, in addition is developing a pipeline of novel biomarkers which can predict the risks of obesity, breast cancer and cardiovascular diseases.
About International Conference on Advances in Critical Care Nephrology: The AKI & CRRT conference provides a comprehensive review of advances in clinical care, research and technology in critical care medicine with a focus on the kidney and renal support techniques.
About penKid®: penKid® is the very first functional kidney marker that works in blood. penKid® is independent from comorbidities and inflammation and provides timely information about the changing kidney function in critically ill patients. sphingotest® penKid® is non-inferior to the gold standard in vivo measurement of glomerular filtration rate (GFR). These features enable physicians to diagnose and closely monitor worsening and improving kidney function in critically ill patients.
Patrick McLaughlin, APR
16761 Hennigsdorf, Germany
Phone +49 33 02/2 05 65-0