Astute Medical, Inc. Signals Success for Nephrocheck® Test in Aki Risk Assessment Study of Post Cardiac Surgery Patients
SAN DIEGO, March 31, 2014 /PRNewswire/ -- Published this week in PLOS ONE is an observational study by Dr. Alexander Zarbock of the University of Muenster. Utilizing the CE-marked Astute Medical NephroCheck® Test, Dr. Zarbock was able to show the usefulness in predicting development of acute kidney injury (AKI) after cardiac surgery.
AKI is believed to occur in up to 40 percent of adults who undergo cardiac surgery. The condition is asymptomatic and difficult to predict. Clinical evaluation and existing renal tests are not reliable for risk assessment in critically ill patients.
"We are pleased that one of the top European hospitals has confirmed the strong performance of the NephroCheck® Test," said Chris Hibberd, Astute Medical Chief Executive Officer. "This study contributes to an important body of work that continues to establish that the NephroCheck® Test gives physicians valuable information about the risk of developing AKI."
The NephroCheck® Test utilizes fluorescence immunoassay technology to detect and measure two biomarkers of AKI, tissue inhibitor of metalloproteinase 2 (TIMP-2) and insulin-like growth factor binding protein 7(IGFBP-7) in human urine. The release of TIMP-2 and IGFBP-7 by kidney cells acts as a biological alarm signaling that the cells are acutely stressed and the kidney is at risk for AKI, which can cause permanent damage and loss of function.
In the study researchers enrolled 50 patients who had undergone cardiac surgery with the use of cardiopulmonary bypass and who were determined to be vulnerable to AKI. The NephroCheck® Test provided valuable information about the patients' risk of development of AKI after the surgical procedure.
AKI is a significant global health hazard that strikes up to seven percent of hospitalized patients. Patients with AKI are subject to risk of increased mortality and morbidity, longer lCU stays, and higher in-hospital cost.
The incidence is much higher among critically ill patients, with up to half developing some degree of AKI during their illness. While the incidence (2.1/1000 population) is similar to that of acute myocardial infarction, or heart attack, a recent study suggests that AKI could, in fact, be deadlier.
AKI has been associated with higher cost of care, especially in the intensive care unit (ICU). A 2008 study of U.S. post-cardiac surgery patients published in Nephrology Dialysis Transplantation reported that critically ill patients with no AKI had an ICU cost of $13,836 and 1.4 days of length of stay. In comparison, patients with severe AKI had an ICU cost of up to $49,328 and up to 5.4 days of length of stay.
The NephroCheck® Test and the Astute140® Meter are available for sale in Europe. The NephroCheck® Test and the Astute140® are not available for sale in the United States.
About Astute Medical, Inc.
Named by the Wall Street Journal as one of the Top 10 Healthcare Start-Ups of 2012, Astute Medical is dedicated to improving the diagnosis of high-risk medical conditions and diseases through the identification and validation of protein biomarkers that can serve as the basis for novel diagnostic tests. The Company's focus is community- and hospital-acquired acute conditions that require rapid diagnosis and risk assessment. Astute Medical's current areas of interest include abdominal pain, acute coronary syndromes, cerebrovascular injury, kidney injury and sepsis.
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The NephroCheck® Test and the Astute140® Meter are not available in the United States. For information regarding trademarks and other intellectual property applicable to this product, including international trademarks, please see AstuteMedical.com/about/intellectual-property.
PN 0285 Rev A 2014/03/18
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