Pioneering diagnostics

NEPHROCHECK® Biomarkers TIMP-2 and IGFBP7 Included in Acute Dialysis Quality Initiative Recommendations

12 June, 2018

The biomarkers in the NEPHROCHECK® test, an FDA-cleared and CE-marked urine test that indicates kidney stress in advance of acute kidney injury (AKI), have been included in a second set of consensus recommendations, the Acute Dialysis Quality Initiative (ADQI). This follows the inclusion of this assay in the guidelines issued recently by ERAS® Cardiac Surgery

ADQI is an international, interdisciplinary organization with over 150 members from leading universities around the world. Founded in 2000, the non-profit, member run organization’s mission is to provide an objective, dispassionate distillation of the literature and description of the current state of practice of diagnosis and management of acute kidney injury as well as other conditions in which dialysis and related therapies are applied to acutely ill patients.

The ADQI recommendation follows the recent publication of two randomized controlled trials[i],[ii] that demonstrated significant improvement in patient outcomes, length of stay, and decreased costs due to AKI following cardiac and non-cardiac surgery by using NEPHROCHECK® to guide the use of kidney-protecting interventions.

Since its founding in 2000, ADQI has been advancing the international standard of care for acute kidney health,” said Pr. Claudio Ronco, MD, current President of ADQI. John Kellum, MD, MCCM, past President of ADQI, added: “As research and literature has advanced and market access has occurred, biomarkers have shown that they can play an important role in improving patient care and outcomes as they have become more routinely used in practice. As such they are now included in the consensus recommendations. In the future they are likely to change the way we define acute kidney injury.

We are thrilled that the two biomarkers in the NEPHROCHECK® test are included once more in consensus guidelines,” said Mark Miller, Executive Vice President and Chief Medical Officer for bioMérieux. “The increasing recognition of the NEPHROCHECK® test in evidence based patient care recommendations will help standardize the medical approach to prevent AKI and improve patient outcomes. This test brings high medical value information to clinicians in order to help them make actionable decisions which are crucial to protect patients’ kidneys from both acute and long term damage.

The guidelines “Cardiac and Vascular Surgery-Associated Acute Kidney Injury: The 20th International Consensus Conference of the ADQI (Acute Disease Quality Initiative) Group”, or ADQI 20 for short, were published June 1, 2018 in the Journal of the American Heart Association (JAHA).

 

About AKI

AKI is a frequent complication in patients undergoing major surgery, and is known to increase morbidity, mortality and costs[iii]. Additional AKI-associated expenses during U.S. hospitalizations have been reported at $38,000 per patient[iv], resulting in U.S. healthcare expenditures between $5 to $24 billion annually[v]. Currently available indicators of AKI, such as elevated blood levels of creatinine, may not be present until kidney damage has already occurred[vi]. Recent studies have called for the pursuit of innovative strategies to combat this major public health concern[vii],[viii].

About The NephroCheck® Test

The NEPHROCHECK® test detects two biomarkers, urinary tissue inhibitor of metalloproteinases-2 (TIMP-2) and insulin-like growth factor binding protein 7 (IGFBP7), that increase in a patient’s urine in response to early kidney cell stress which can lead to AKI. This allows the biomarkers to function as an early alarm of kidney stress before progression to AKI so that maneuvers to protect the kidneys can be undertaken[ix].

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 www.nepfrocheck.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.

About ASTUTE MEDICAL

Astute Medical Inc., a company dedicated to improving the diagnosis of high-risk medical conditions and diseases through the identification and validation of protein biomarkers. In particular, Astute developed the NEPHROCHECK® Test, an FDA-cleared test for the early risk assessment of acute kidney injuries (AKI) based on the level of two biomarkers, IGFBP-7 (Insulin-like Growth Factor-Binding Protein-7) and TIMP-2 (Tissue Inhibitor Metalloproteinases-2).

bioMérieux has announced the acquisition of Astute Medical Inc. on April 4th, 2018.

 


[i] Göcze I, Jauch D, Götz M, et al. Biomarker-guided intervention to prevent acute kidney injury after major surgery: the prospective randomized BigpAK Study. Ann Surg. Published online August 2017.

[ii] Meersch M, Schmidt C, Hoffmeier A, et al. Prevention of cardiac surgery-associated AKI by implementing the KDIGO guidelines in high risk patients identified by biomarkers: the PrevAKI randomized controlled trial. Intensive Care Med. 2017 Jan 21.

[iii] Hobson C, Ozrazgat-Baslanti T, Kuxhausen A, et al. Cost and mortality associated with postoperative acute kidney injury. Ann Surg. 2014;00:1-8.

[iv] Alshaikh H, Katz N, Gani F, et al. Financial Impact of Acute Kidney Injury After Cardiac Operations in the United States. Ann Thorac Surg. 2018 Feb;105(2):469-475.

[v] Silver SA, Chertow GM. The Economic consequences of AKI. Nephron. 2017;137:297-301.

[vi] McCullough PA, Shaw AD, Haase M, 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.

[vii] Thakar CV. Acute Kidney Injury: A Paradigm In Quality and Patient Safety. Adv Chronic Kid Dis. 2017;24(4):192-193.

[viii] Silver SA, Chertow GM. The Economic consequences of AKI. Nephron. https://doi.org/10.1159/000475607. Published online June 9, 2017.

[ix] Kellum JA, Chawla LS. Cell-cycle arrest and acute kidney injury: the light and dark sides. Nephrol Dial Transplant. (2015) 0: 1–7doi: 10.1093/ndt/gfv130.

 

 

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