SAN DIEGO - Aug.1, 2016 - Citing two recent studies,1,2 further validating the NephroCheck® Test, Astute Medical Co-founder and Chief Scientific Officer Paul McPherson, Ph.D., said hospital clinicians seeking better tools to aid in risk assessment for acute kidney injury (AKI) to improve patient care can be assured that numerous and diverse analyses affirm the utility of the NephroCheck® Test. Astute Medical and Ortho Clinical Diagnostics are demonstrating the test at the American Association for Clinical Chemistry (AACC) Conference, showing how it can be used to identify patients at risk for moderate to severe AKI, with the aim of helping to prevent permanent kidney damage or death.
As the incidence of AKI has continued to increase, killing an estimated 2 million people worldwide each year,3 the medical and research communities have called for better methods to rapidly identify patients likely to develop this potentially deadly condition. In response, an industry has sprung-up in recent years with companies seeking to find biomarkers that can accurately predict AKI.3
"Multiple studies have validated the NephroCheck® Test as a reliable tool that helps clinicians make more informed decisions about high risk patients, with these two recent publications adding to that growing body of literature," McPherson said. "One study shows the test is not deterred by the presence of common chronic comorbidities that have affected the performance of previous generations of biomarkers.1 The other study shows the test is informative about a patients risk for AKI, even in very difficult cases in which expert clinicians could not agree unanimously on the appropriate diagnosis."2
The NephroCheck® Test is being highlighted during the AACC conference at the Pennsylvania Convention Center in Philadelphia, through Aug. 4, at Orthos booth, #1100. Ortho is Astute Medicals sales agent in the United States and certain European countries.
The most recent studies on the NephroCheck® Test and the two biomarkers it utilizes, urinary tissue inhibitor of metalloproteinases-2 (TIMP-2) and insulin-like growth factor binding protein 7 (IGFBP-7), were published online June 23, in the journal Nephrology, Dialysis, Transplantation.
In the first study,1 the authors said they saw no significant impairment in the performance of the cell cycle arrest biomarkers used in the NephroCheck® Test due to the presence of common, comorbid conditions, including chronic kidney disease, diabetes mellitus and congestive heart failure.
Developing biomarkers to accurately predict AKI risk earlier than current methods allow has been an important goal of research, the studys authors wrote. However, AKI biomarkers have shown variable performance in the setting of comorbid disease.1 This is particularly problematic because comorbidities can be well-recognized risk factors for AKI.1
In the analysis of 1131 patients enrolled in two previous multicenter studies, TOPAZ4 and SAPPHIRE,5 TIMP-2 with IGFBP-7 was significantly higher in AKI versus non-AKI patients, both overall and within each comorbidity group. The AUC in predicting AKI was 0.81 overall. The sensitivity and specificity of the test was not impacted by any of the chronic comorbidities analyzed.
The second study2 describes clinical adjudication of AKI in the pivotal 408-patient multicenter TOPAZ trial, conducted as part of the FDA clearance for the NephroCheck® Test. An adjudication panel was convened because AKI remains a clinical diagnosis, despite well-established consensus criteria, the studys authors wrote.
The analysis showed that NephroCheck® Test results (AKIRisk Scores) correlated to clinically adjudicated AKI better than to KDIGO criteria.6 Notably, in difficult to assess cases, the test discriminated AKI risk well.
"Even in cases where experts disagree with one another or with KDIGO criteria, the biomarker test provides further information. This is important because these are precisely the kinds of cases where biomarkers are needed most," the authors wrote.
The study also showed that a substantial number of clinically relevant AKI cases might be missed by KDIGO criteria alone, the authors wrote.
"The study highlights the importance of clinical adjudication of AKI for biomarker studies and lends further support for the value of urine TIMP-2 and IGFBP-7," the authors concluded.
This biomarker validation study is the first to the authors knowledge to utilize clinical adjudication of AKI.
Important Information About The NephroCheck® Test
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 on the NephroCheck® Test visit NephroCheck.com.
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 Medicals 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.
For information regarding trademarks and other intellectual property applicable to this product, please see www.astutemedical.com/us/about/intellectualproperty. PN0586 Rev B 2016/08/01
1 Heung M, Ortega L, et al. Common chronic conditions do not affect performance of cell cycle arrest biomarkers for risk stratification of acute kidney injury. Nephrol Dial Transplant (2016) 0: 1–8 doi: 10.1093/ndt/gfw241
2 Liu K, Vijayan A, et al. Clinical adjudication in acute kidney injury studies: findings from the pivotol TIMP-2*IGFBP-7 biomarker study. Nephrol Dial Transplant (2016) 0: 1–6 doi: 10.1093/ndt/gfw238.
3 Murugan R, Kellum JA. Acute kidney injury: what’s the prognosis? Nat. Rev. Nephrol. 7, 209–217 (2011); published online 22 February 2011; doi:10.1038/nrneph.2011.13
4 Bihorac A, Chawla LS, Shaw AD, et al. Validation of cell-cycle arrest biomarkers for acute kidney injury using clinical adjudication. Am J Respir Crit Care Med 2014; 189: 932–939
5 Kashani 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
6 Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work Group. KDIGO 2012 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease. Kidney Inter., Suppl. 2013; 3:1-150.