First study to demonstrate use of NephroCheck® Test for AKI risk in patients with sudden worsening of heart failure symptoms.
SAN DIEGO – March 15, 2017 – Astute Medical, Inc., developer of biomarkers for better healthcare, today said that newly published findings show the NephroCheck® Test could help clinicians identify risk of acute kidney injury (AKI) in patients with a sudden worsening of heart failure symptoms, a condition known as acute decompensated heart failure (ADHF). The study,1 published in Clinical Cardiology, is the first to investigate the risk assessment capabilities of TIMP-2 and IGFBP7, the urinary biomarkers measured by the test, in Emergency Department (ED) patients with ADHF.
“Among hospitalized patients, approximately 25 percent have evidence of acute kidney injury, which defines them as Type 1 cardiorenal syndrome patients,” said Peter A. McCullough, M.D., MPH, president of the Cardio Renal Society of America. “These patients are often diagnosed late and have increased lengths of stay, rehospitalizations, and mortality.”
The study “Urinary [TIMP-2] x [IGFBP7] for Risk Prediction of Acute Kidney Injury in Decompensated Heart Failure” conducted at Robert Bosch Hospital in Stuttgart, Germany, enrolled patients during initial workup in the ED. The investigators found that [TIMP-2] x [IGFBP7] measurements identified ADHF patients at risk of developing moderate to severe (stage 2-3) AKI for samples collected within 24 hours of enrollment. The authors also reported an area under the curve (AUC), an estimate of test accuracy, of 0.84 (95 percent CI: 0.72-0.93), a sensitivity of 86 percent at a 0.3 cutoff and specificity of 95 percent at the 2.0 cutoff for prediction of AKI stage 2–3.
“Physicians are looking forward to the widespread use of a test that can detect AKI long before the rise of serum creatinine and allow doctors an opportunity to adjust medications and provide more effective therapy for this important patient population,” said Dr. McCullough.
“This study adds to the growing body of clinical evidence showing that the NephroCheck Test can overcome the limitations of earlier-generation biomarkers,” said Paul McPherson, Astute Medical’s chief scientific officer. ”The authors noted that this biomarker combination is superior to certain other biomarkers for AKI risk prediction in critically ill patients. Furthermore, the performance is consistent with previous studies utilizing the NephroCheck Test for patients at risk for AKI of various etiologies and across diverse hospital settings.”
Important Information About The NephroCheck® Test
In the United States, the NephroCheck® Test System is intended to be used in conjunction with clinical evaluation in patients who currently have or have had within the past 24 hours acute cardiovascular and or respiratory compromise and are intensive care unit (ICU) patients as an aid in the risk assessment for moderate or severe AKI within 12 hours of patient assessment. The NephroCheck® Test System is intended to be used in patients 21 years of age or older. For more information visit NephroCheck.com.
In the EU (European Union), the NephroCheck® Test result is intended to be used in conjunction with clinical evaluation as an aid in the risk assessment of acute kidney injury in the critically ill. The NephroCheck® Test is indicated for prescription use only.
About Astute Medical, Inc. 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.
Astute Medical is a founding corporate partner of 0by25, a human rights initiative aimed at eliminating preventable and treatable deaths from AKI worldwide by 2025.
Astute Medical’s NephroCheck® Test received 510(k)-clearance through the FDA’s de novo classification. The test is CE-marked and available in Europe.
For additional information, please visit AstuteMedical.com.
Astute Medical®, the AM logo, Astute140®, NephroCheck®, the NephroCheck® logo, and AKIRisk® are registered trademarks of Astute Medical, Inc. in the United States. For information regarding trademarks and other intellectual property applicable to this product, including international trademarks, please see www.astutemedical.com/about/intellectualproperty. PN0632 Rev A 2017/03/14
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1Schanz M, Shi J, Wasser C, Alscher MD and Kimmel M. Urinary [TIMP-2] x [IGFBP7] for risk prediction of acute kidney injury in decompensated heart failure. Clin Cardiol. 2017. https://doi.org/10.1002/clc.22683.