New Research Shows NEPHROCHECK® Test Predicts Acute Kidney Injury Risk For Transaortic Valve Implant Patients

• Test outperforms existing standard-of-care test
• Doctors could use information to improve the treatment approach

San Diego, CA /PRNewswire/ - Astute Medical, Inc., developer of biomarkers for better healthcare, today said that newly published findings show that the Company's NEPHROCHECK® Test may help physicians identify risk of a serious complication in patients who have undergone transcatheter aortic valve implantation (TAVI; also called TAVR, transcatheter aortic value replacement). The study, published in BMC Anesthesiology, demonstrates that two urinary biomarkers measured by the test, TIMP-2 and IGFBP-7, are highly sensitive and specific for the prediction of moderate to severe acute kidney injury (AKI) in TAVI.

It is believed that up to 57 percent of TAVI patients develop AKI, which can impair kidney function, lead to further complications1and heighten risk of death.² Patients suffering AKI may also endure longer hospital stays requiring intensive care.²

The study showed that when measured one day after TAVI, [TIMP-2]*[IGFBP7] predicted eventual AKI stage 2 or 3, per KDIGO classification, with 100 percent sensitivity and 90 percent specificity. Test sensitivity is the ability of a test to correctly identify those with the disease, whereas test specificity is the ability of the test to correctly identify those without the disease.

In summarizing their findings authors said, "In our prospective observational trial of 40 patients undergoing transapical or transaortic TAVI the elevation of urinary [TIMP 2]*[IGFBP7] concentrations within 24h after surgery is associated with the onset of postoperative AKI within the next 72h. [TIMP 2]*[IGFBP7] urine concentrations show an excellent diagnostic accuracy for the prediction of severe AKI requiring renal replacement therapy. In contrast, neither serum creatinine concentrations (preoperative and postoperative) nor changes of GFR were able to predict the occurrence of AKI reliably. Our results clearly demonstrate that [TIMP 2]*[IGFBP7] can be used to identify patients at high risk for AKI."

Authors also noted that older biomarkers had disputable prognostic impact on predicting post-TAVI AKI, citing several recently published studies showing comparable readings of early-generation biomarkers for post-TAVI patients who developed AKI and for those with normal renal function.

Due to its lack of obvious signs and symptoms, AKI is a condition that is difficult to identify.3 Study authors stated that, "If recognized earlier, nephroprotective measures could be considered to reduce exposure to renal insults and potentially avoid the development of higher stage AKI."

"The era of precision medicine is upon us," said Paul McPherson, Astute's chief scientific officer. "As in previous studies highlighting sepsis, surgical, renal and cardiovascular patient populations,^4,5,6 the NEPHROCHECK® Test showed strong performance for AKI risk assessment in the TAVI/TAVR patient population.

"We share the authors' belief that the combination of physician insight and new information from the NEPHROCHECK® Test could lead to optimized post-op treatment strategies that may help alleviate the deadly and costly burden of AKI."

The NEPHROCHECK® Test is a first-of-a-kind laboratory test to help 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

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.

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.

For information regarding trademarks and other intellectual property applicable to this product, please seeAstuteMedical.com/about/intellectual-property. PN0600 Rev A 2016/09/12

¹ Dusse et al. Early prediction of acute kidney injury after transapical and transaortic aortic valve implantation with urinary G1 cell cycle arrest biomarkers. BMC Anesthesiology (2016) 16:76 DOI 10.1186/s12871-016-0244-8.
² Hobson C, Ozrazgat-Baslanti T, Kuxhausen A, et al. Cost and mortality associated with postoperative acute kidney injury. Ann Surg. 2014;00:1-8.
³ Ronco C, Ricci Z. The concept of risk and the value of novel markers of acute kidney injury. Crit Care. 2013;17:117-118.
⁴ Honore PM, Nguyen HB, Gong M et al. Urinary Tissue Inhibitor of Metalloproteinase-2 and Insulin-Like Growth Factor-Binding Protein 7 for Risk Stratification of Acute Kidney Injury in Patients With Sepsis. Critical Care Medicine. Published Online June 28, 2016. doi: 10.1097/CCM.0000000000001827.
⁵ Gunnerson el al. TIMP2•IGFBP7 Biomarker Panel Accurately Predicts Acute Kidney Injury In High Risk Surgical Patients. J Trauma Acute Care Surg. 2016 Feb;80(2):243-9.
⁶ 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.