NEPHROCHECK® TEST SYSTEM RECEIVES FDA CLEARANCE IN UNITED STATES FOR RISK ASSESSMENT OF ACUTE KIDNEY INJURY
SAN DIEGO – Monday, September 8th 2014 – A novel test used to assess risk for acute kidney injury (AKI) could help physicians significantly improve management of intensive care unit (ICU) patients at risk for AKI, who annually account for 5 million admissions.1 Inadequacies in assessment and management of AKI have been cited as contributing to an increased number of deaths and excess healthcare costs.2,3
Astute Medical, Inc. announced today that it has received 510(k) clearance through the Food and Drug Administration’s (FDA’s) de novo classification process for its first biomarker-based immunoassay known as the NephroCheck® Test System, clearing the path to commence sales in the coming weeks with its strategic partner Ortho Clinical Diagnostics, Inc., whom Astute Medical has designated as the exclusive sales agent for Astute’s NephroCheck® Test, which is the only biomarker test available to assess risk of AKI.
While most are largely unaware of AKI, in hospitalized patients the condition has been shown to have worse outcomes than heart attack.4 The condition often occurs in the sickest patients, particularly those with sepsis or who have undergone major surgery, including cardiovascular surgery.5,6,7
“The availability of biomarkers for AKI risk assessment can play a pivotal role in evolving practice from a ‘wait and see’ era to a ‘let’s prevent and treat it domain” said Dr. Kianoush Kashani of the Mayo Clinic. “Clinicians will be able to integrate the test with clinical information to improve decision-making, which aligns with the goal of offering better preventive care and earlier action.”
The NephroCheck® Test System will introduce new information into the patient assessment process helping physicians establish which patients are at risk for moderate to severe AKI. Currently, in the United States, no other in vitro diagnostic device is available for the same intended use as the NephroCheck® Test System.
“I’m delighted at the emergence of new tools that may help improve care for patients at risk for AKI,” said Dr. John Kellum a critical care physician at University of Pittsburgh Medical Center and principal investigator. “While more physicians are aware of the need to assess patient risk for AKI, we have lacked a reliable method of performing this risk assessment.”
The NephroCheck® Test System detects the presence of insulin-like growth-factor binding protein 7 (IGFBP7) and tissue inhibitor of metalloproteinases (TIMP-2) in the urine, which are associated with acute kidney injury. Within 20 minutes, the test provides a score based on the amount of the proteins present that correlates to the patient’s risk of developing AKI within 12 hours of the test being performed. The biomarkers were discovered and validated through large multi-center clinical studies.8,9
“Astute is committed to developing innovative tests to provide better healthcare. We are excited to introduce the first real improvement in renal testing in over 60 years,” said Chris Hibberd, Astute Medical chief executive officer. “Together with our partner, Ortho-Clinical Diagnostics, we look forward to making the NephroCheck® Test System available. We thank our employees and clinical investigators who helped make this important advancement in AKI.”
The NephroCheck® Test System – Important information
The Astute Medical 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 ICU patients as an aid in the risk assessment for moderate or severe acute kidney injury (AKI) within 12 hours of patient assessment. The NephroCheck® Test System is intended to be used in patients 21 years of age or older.
The NephroCheck® Test System consists of the Astute140® Meter, NephroCheck® Test Kit, NephroCheck® Liquid Controls Kit, and NephroCheck® Calibration Verification (Cal Vers) Kit.
The NephroCheck® Test System will be available to hospitals in the United States in the coming weeks and is currently available in the European Union. To obtain more information about the product visit the products page at AstuteMedical.com.
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.
About Ortho-Clinical Diagnostics, Inc.
Ortho-Clinical Diagnostics, Inc. delivers high-quality in vitro diagnostic products that give healthcare professionals around the world the knowledge they need to make better treatment decisions sooner. The company serves the global transfusion medicine community with donor screening and blood typing products to help ensure every patient receives blood that is safe, the right type and the right unit. Ortho Clinical Diagnostics also brings sophisticated information management, testing technologies and automation and interpretation tools to clinical laboratories worldwide to help them run more efficiently and improve patient care. For more information, visit www.orthoclinical.com.
Dr. Kellum is a paid consultant for Astute Medical, Inc.
Astute Medical®, the AM logo, Astute140®, NephroCheck® and the NephroCheck® logo are registered trademarks of Astute Medical, Inc. in the United States. AKIRisk™ is a trademark of Astute Medical, Inc. For information regarding trademarks and other intellectual property applicable to this product, including international trademarks, please see AstuteMedical.com/about/intellectual-property. PN0279 Rev B 2014/10/07
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