German diagnostic company SphingoTec GmbH (Hennigsdorf) and Chinese Company Shuwen Biotech Co. Ltd (Deqing) have signed an agreement to market Sphingotec’s biomarkers portfolio in China.
Under the agreement, Shuwen will directly develop and market Sphingotec reliable immunoassays. For acute care, these are the Sphingotest® penKid and Sphingotest® bio-ADM tests, set to improve therapy monitoring and outcomes in intensive care units and emergency departments.
For the “Medicine of the Future” predictive test field, the sphingotest® pro-NT, sphingotest® pro-ENK, sphingotest® vr-hGH and sphingotest® ApoE4 are set to improve prediction and hence timely prevention of life-threatening diseases such as breast cancer, cardiovascular disease and Alzheimer, respectively.
In the acute care field, bio-ADM is a biomarker for vascular dysfunction, oftentimes causing worsening or escalation of conditions in various disease states. For example, bio-ADM predicts septic shock in critically ill patients and thus can guide treatment choices. In congestive heart failure, bio-ADM is the first biomarker that identifies patients having (residual) edema, caused by incomplete response or therapy resistance to decongestion therapy with loop diuretics. Septic shock is the most expensive conditions treated in the US hospital with a mortality rate of up to 80%, while unidentified residual congestion is the major cause for re-hospitalization and post-discharge mortality in congestive heart failure patients causing 30% of deaths and global annual cost of US$39bn.
penKid is a kidney function biomarker predictive for development of acute kidney Injury (AKI), a condition that complicates up to 30% of all hospital admission and that widely increase mortality and length of stay.
„We are delighted that Shuwen will distribute our biomarker portfolio in China“, said Dr. Andreas Bergmann, founder and CEO of SphingoTec GmbH. „Our patent-protected assays support physicians with information needed to improve patient management in acute settings and in prevention of life-threatening diseases“.
„The introduction of sphingotec tests is a major step forward for the Chinese healthcare system“, said Jay Z. Zhang, CEO of Shuwen Biotech. „Both acute care and disease prevention will vastly benefit from the sphingotec® biomarkers by supporting timely and clear clinical decision making to change patient outcome.
About penKid: penkid is the very first plasma marker to monitor renal function, which 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) and penkid is elevated about 24-48 h earlier than the standard marker serum creatinine in patients developing acute kidney injury (AKI). These features enable physicians to predict, diagnose and closely monitor worsening and improving kidney function in critically ill patients. In congestive heart failure, penKid allows to adjust diuretics dosage to the situation in individual patients.
About bio-ADM: As a marker of acute vascular endothelial dysfunction, bio-ADM enables both prediction of circulatory shock, e.g. in septic patients, and prediction of residual, diuretic resistant congestion in acute heart failure patients. bio-ADM plasma levels below the cut-off value of 70 pg/ml indicate successful diuretic therapy.
About pro-NT & pro-ENK: pro-NT is a strong risk predictor for the development of breast cancer in the next five years. This predictive power can be further enhanced by the measurement of Sphingotest® pro-ENK, which results can be added on top of pro-NT to further quantify the risk of developing breast cancer. In contrast to genetic testing that solely focus on the encoded predisposition to develop breast cancer, pro-NT and pro-ENK values represent the phenotype and show to change following lifestyle adjustments.
About vr-HgH: vr-hGH allows for the assessment of future onset of cardiovascular events in male, such as stroke and myocardial infarction, with a predictive power that largely overshadow the currently known measured parameters like troponin and natriuretic peptides.
About ApoE4: ApoE4 is a reliable and simple method to detect Apolipoprotein 4, a protein that is widely known to be connected to the future onset of Alzhaimer Disease. Sphingotest® ApoE4 is much simpler and cost-effective than the currently used genetic tests.
SphingoTec GmbH (Hennigsdorf, Germany) develops innovative biomarkers for prediction, diagnosis and therapy monitoring of AKI, congestive heart failure and septic shock. The company, founded by Dr. Andreas Bergmann in 2002, has also in its portfolio biomarkers which can predicts risks of obesity, breast cancer and cardiovascular diseases.
Shuwen Biotech Co. LTD Based in China and led by U.S. and European diagnostic industry veterans, Shuwen Biotech is engaged in licensing, developing, marketing and distributing innovative products and services for disease diagnosis and personalized medicine. The company strives to provide China’s doctors and their patients with a comprehensive menu of the most innovative products and services for improved disease prediction, screening, diagnosis, prognosis and treatment in the areas of cancer, maternal fetal medicine, acute care, and preventive testing.