Astute Medical Says Sharp HealthCare First In State To Implement Biomarker-based AKI Risk Assessment Using NephroCheck® Test

SAN DIEGO, Nov. 17, 2016 /PRNewswire/ -- Astute Medical, Inc., developer of biomarkers for better healthcare, today announced that Sharp HealthCare, one of Southern California's leading health care providers, has become the first in the state to begin using a first-of-its-kind risk assessment test for acute kidney injury (AKI), a stealthy, unpredictable and potentially deadly condition that is a common complication for patients in intensive care.

Astute Medical's NephroCheck^® Test will allow Sharp clinicians to more quickly identify patients at risk of developing AKI so they can intervene earlier and reduce the threat of irreparable kidney damage, said John Videen, M.D., a nephrologist at Sharp Chula Vista Medical Center. Once patients develop AKI, mortality rate, risk of complications, length of hospital stay, cost¹ and readmissions² can more than double.

"Nephrologists have been waiting decades for a test to help us detect kidney stress that can lead to kidney injury," Dr. Videen said. "I'm excited to start using it, and believe it will help get a jump on the condition."

AKI is as common and life-threatening as a heart attack. But unlike a heart attack, it has no symptoms and can progress silently for hours to days, sometimes causing irreversible damage before it is detected.³ About half of the 5 million⁴ people admitted to intensive care units in the United States each year will develop AKI.⁵ About 2 million people worldwide die from AKI annually.⁶

The NephroCheck^® Test helps clinicians 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.⁷

The test quantitatively measures two urinary biomarkers – tissue inhibitor of metalloproteinase 2 (TIMP-2) and insulin-like growth factor binding protein 7 (IGFBP-7), which have been related to early kidney stress. In high-risk hospital patients, this stress can signal the threat of moderate to severe AKI in the future.⁸

"I've envied cardiologists, who've had many tests for the heart, while we have had so few for the kidneys," Dr. Videen said. "Previously, when we had a patient with kidney dysfunction or abnormal test results, we couldn't tell if the kidneys were showing a normal reaction to stress or if they were headed toward AKI. To me, this is how the test comes in handy."

Sharp nurses will order the test for patients with sepsis and those receiving cardiac care who are not progressing as expected, he said. Both are high-risk groups for AKI. Sepsis is the most common cause of AKI in critically ill patients (47.5 percent).⁹ And for cardiac surgery patients, developing AKI increases risk of death during hospitalization by 500 percent.¹⁰ A nephrologist will be notified when patients' biomarker levels indicate they are at risk for AKI.

"This will allow us to get a 12-hour head start on the disease," Dr. Videen said. "It may give physicians enough advance warning that they can implement kidney-supportive measures, such as withholding nephrotoxic drugs."  

Prior to the NephroCheck^® Test, clinicians could detect AKI only after it had already occurred.³ "By the time I'd get the call about a patient, the only decisions left were whether to start dialysis and what kind of dialysis to use," Dr. Videen said.

According to Dr. Videen, the primary motivation for using the test is to provide the highest quality care and to potentially reduce the rate of complications. "I'm sure administrators also recognized it might have secondary benefits of reducing hospitals costs."

"We are delighted to have our technology, developed here in San Diego, deployed to help Sharp clinicians more quickly assess the patients at risk for AKI, sparing them health complications that could be deadly or have debilitating, life-long effects," said Paul McPherson, Astute Medical's chief scientific officer.

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 additional information on the test, please visit Nephrocheck.com

About Astute Medical, Inc.

Astute Medical is devoted to improving patient healthcare outcomes through the identification and validation of novel biomarkers.

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 has developed the NephroCheck^® Test for use in determining whether a hospitalized patient is 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.

The Company 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/US/About/IntellectualProperty. PN0606 Rev B 2016/11/18

¹ Dasta 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.

² Brown JR, Parikh CR, Ross CS, et al. Impact of perioperative acute kidney injury as a severity index for thirty-day readmission after cardiac surgery. Ann Thorac Surg. 2014;97(1):111-7.

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 Society of Critical Care Medicine. Critical Care Statistics [accessed 2014 September 24]. http://www.sccm.org/Communications/Pages/CriticalCareStats.aspx.

⁵ Mandelbaum 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.

⁶ 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.

⁷ Lewington AJP, Certa J, Mehta RL Raising Awareness of Acute Kidney Injury: A Global Perspective of a Silent Killer.Kidney Int 2013;84(3):457-467.

⁸ 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.

⁹ Uchino S et al. Acute renal failure in critically ill patients: a multinational, multicenter study. JAMA. 2005;294:813-818.

¹⁰ Oneal JB, Shaw AD, Billings FT 4^th, Acute kidney injury following cardiac surgery: Current understanding and future directions. Crit Care. 2016 Jul 4;20(1):187. doi: 10.1186/s13054-016-1352-z.

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SOURCE Astute Medical, Inc.

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