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New Study Validates NephroCheck® Test For Risk Of Acute Kidney Injury

SAN DIEGO, March 3, 2014  /PRNewswire/ -- A multi-center study published online in the American Journal of Respiratory and Critical Care Medicine (AJRCCM) validates the performance of the CE-marked NephroCheck® Test, which assesses a critically ill patient's risk of developing acute kidney injury (AKI).

The NephroCheck® Test, developed by Astute Medical, Inc., 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. The recently published Kidney Disease Improving Global Outcomes (KDIGO) Guideline for AKI recommends prompt evaluation of patients along with the implementation of kidney-sparing interventions for patients determined to be at risk and thus vulnerable to permanent damage from unchecked AKI.

"This first-of-its-kind study utilized clinical adjudication, the most rigorous standard, to prospectively validate two biomarkers for risk assessment of AKI," said first author Dr. Azra Bihorac of the University of Florida. "Our study found that the product of the two biomarkers can identify a high risk for near-term AKI in a wide range of critically ill patients. These are the very patients needing improved delivery of recommended interventions, such as those included in the KDIGO guideline."

Globally, AKI is emerging as a significant public hazard given its link to increased mortality and morbidity, longer lCU stays, and higher in-hospital cost. Its incidence (2.1/1000 population) is similar to that of acute myocardial infarction, or heart attack. A study recently published in the Clinical Journal of the American Society of Nephrology suggested that AKI could be more deadly than heart attack. Unlike heart attack, AKI is asymptomatic lacking warning signs such as pain, shortness of breath or other clinical symptoms, particularly in the early stages when intervention is most beneficial.

The incidence of AKI is high among critically ill patients, with up to 50 percent developing some degree of AKI during their illness. Patients developing AKI have a greater risk of death prior to hospital discharge and survivors appear to be at significant short- and long-term risk for complications.

AKI has been associated with higher cost of care, especially in the intensive care unit (ICU). A 2008 study of 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.

In the AJRCCM study titled "Validation of Cell-Cycle Arrest Biomarkers for Acute Kidney Injury Using Clinical Adjudication," investigators enrolled 420 critically ill patients in 23 medical centers. The primary analysis was the ability of the biomarkers to predict moderate to severe AKI within 12 hours of test measurement. AKI was adjudicated by a committee of three independent expert nephrologists who were blinded to the results of the test.

"AKI remains one of the most common complications among critically ill patients, yet we lack a precise and reliable method of discerning risk," said senior author Dr. John Kellum of the University of Pittsburgh. "By providing actionable information, this study advances the translation of biomarker technology into routine practice."

The NephroCheck® Test and the Astute140® Meter are available in Europe. The NephroCheck® Test and the Astute140® Meter are not available 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. For additional information, please visit AstuteMedical.com.

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 0278 Rev A 2014/02/25



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