Sessions Highlight Risk Assessment Capabilities of NephroCheck® Test Biomarkers
SAN DIEGO – March 6, 2017 – Astute Medical, Inc., developer of biomarkers for better healthcare, today previewed presentations highlighting advances in the area of acute kidney injury (AKI) risk assessment to be presented at the 22nd CRRT International Conference on Advances in Critical Care Nephrology (CRRT) in San Diego March 7 through March 10. The presentations relate to study of the biomarkers TIMP-2 and IGFBP-7, which were identified1 and validated2 as biomarkers of AKI risk in clinical studies leading to the commercialization of Astute Medical’s NephroCheck Test.
Details of the presentations follow:
Title: Biomarker Guided Management of AKI: Strategies for Improving Care
Speakers: Lakhmir Chawla, M.D. and John Kellum, M.D. (Moderators) Alex Zarbock, M.D., Kianoush Kashani, M.D. and Azra Bihorac, M.D.
Date: Thursday, March 9
Time: 12:15-1:45 p.m.
Session: Future Trends in CRRT and Critical Care
Title: Prevention of Cardiac Surgery Associated AKI: The Prev AKI Trial
Author: Alex Zarbock, M.D.
Date: Friday, March 10
Time: 11:00-12:30 p.m.
Title: Cell-cycle arrest biomarkers [TIMP2]*[IGFBP7] for risk stratification of acute kidney injury in patients with sepsis
Authors: Marco Fiorentino Ph.D., C Keener, A Smith, John A. Kellum, M.D.
Title: Modulation of IGFBP7 and TIMP2 Expression and Secretion by Clinically Relevant Insults In Vitro.
Authors: David R. Emlet, Ph.D., Seth Morrisroe, Alicia Frank, John A Kellum, M.D.
“We are pleased to see more investigations into the practical clinical utility of the NephroCheck Test biomarkers as a means of gauging the risk for AKI before damage occurs,” said Paul McPherson, Astute Medical chief scientific officer. “We believe this is indicative of an increasing interest in strategies aimed at shifting the AKI paradigm from diagnosis to prevention.”
It is estimated that up to 50 percent of patients in the ICU will develop AKI,3 a condition associated with a tenfold increase in hospital mortality rates,4 exponential increases in cost of care4 and a higher rate of chronic kidney disease.5
Unlike other potentially catastrophic events, such as myocardial infarction, AKI often has no signs or symptoms,6 hindering assessment. Studies suggest that traditional methods of assessing kidney function using serum creatinine could lead to late diagnosis of AKI.7
Clinicians use Astute Medical’s NephroCheck Test to determine if certain hospitalized patients are at risk of developing moderate to severe AKI in the 12 hours following test administration. Early knowledge that a patient is likely to develop AKI may prompt closer patient surveillance and help prevent permanent kidney damage or death.
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 E.U., 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. PN0640 Rev A 2017/03/02
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1Kashani K, Al-Khafaji A, Ardiles T, et al. Discovery and validation of cell cycle arrest biomarkers in human acute kidney injury. Crit Care. 2013;17:R25.
2Bihorac A, Chawla L, Shaw A, et al. Validation of Cell-Cycle Arrest Biomarkers for Acute Kidney Injury Using Clinical Adjudication. Am J Respir Crit Care Med. Vol 189, Iss 8, pp 932–939, Apr 15, 2014.
3Mandelbaum T, Scott DJ, Lee J, et al. Outcome of critically ill patients with acute kidney injury using the AKIN criteria. Crit Care Med. 2011;39(12):2659-2664.
4Dasta JF, Kane-Fill SL, Durtschi, AJ, Pathak DS, Kellum JA. Costs and outcomes of acute kidney injury (AKI) following cardiac surgery. Nephrol Dial Transplant.2008;23:1970-1974.
5Mehta RL, Cerda J, Burdmann EA, et al. International Society of Nephrology’s 0by25 initiative for acute kidney injury (zero preventable deaths by 2025):a human rights case for nephrology. The Lancet. Volume 385, No. 9987, p2616–2643, 27 June 2015
6Ronco C, Ricci Z. The concept of risk and the value of novel markers of acute kidney injury. Crit Care. 2013;17:117-118.
7McCullough PA et al. Diagnosis of acute kidney injury using functional and injury biomarkers: workgroup statements from the tenth Acute Dialysis Quality Initiative Consensus Conference. Contrib Nephrol. 2013;182:13-29.