Ortho Clinical Diagnostics VITROS® NEPHROCHECK® Test for Prediction of Acute Kidney Injury Cleared, Available in Europe

RARITAN, N.J. (June 6, 2017) – Ortho Clinical Diagnostics, a global leader of in vitro diagnostics, today announced the launch of its VITROS^® NEPHROCHECK^® test, the first fully automated risk assessment tool for predicting Acute Kidney Injury (AKI), a serious and potentially fatal condition affecting hospital patients worldwide. The test has received CE Mark clearance, signifying conformance to all EU regulations, and is now available for purchase and use on Ortho’s VITROS^® Systems in Europe.

AKI, the sudden loss of kidney function, can develop without warning and potentially lead to kidney failure and death. Known as a silent killer, AKI is as common and twice as deadly as a heart attack^1,2, causing as many as two million deaths annually worldwide³. AKI is caused by renal stress contributed to by major surgery, drugs, toxins, serious infection, or chronic illness and trauma. Up to 50 percent of patients in intensive care develop some stage of AKI⁴.

“Preventing AKI is one of the biggest unmet clinical and economic needs in health care globally,” said Claudio Ronco, MD, director, Department of Nephrology, Dialysis and Transplantation at the International Renal Research Institute St. Bortolo Hospital. “Late and inaccurate diagnosis can lead to irreversible kidney injury and increased morbidity, mortality and hospital costs. Before the NEPHROCHECK^® test, clinicians could only rely on lagging indicator tools, such as serum creatinine and urine output, but these only detect AKI after kidney damage has already occurred.”

Previously available for testing only on the Astute 140 meter, the NEPHROCHECK^® Test can now also be run on Ortho’s fully automated VITROS^® 3600/5600 Immunodiagnostic Systems. It is a simple urine test that provides lab results in 16 minutes, allowing clinicians to assess the risk of AKI and proactively treat at-risk patients. The NEPHROCHECK^® test is enhanced by the proprietary technologies and benefits only available on Ortho’s VITROS^® systems.

“The first of its kind, the VITROS NEPHROCHECK^® test provides a quick and effective way for doctors to assess which patients are at risk for AKI before kidney damage occurs,” said Robert Yates, chief operating officer of Ortho Clinical Diagnostics. “A significant milestone in the expansion of Ortho’s menu, this test is integrated into existing VITROS^® Systems, which maximizes lab investments, efficiency and output. It provides both clinical and economic value.”

The VITROS NEPHROCHECK was developed under license from Astute Medical.  The NEPHROCHECK^® test was discovered and validated as an AKI risk assessment tool for the development of moderate to severe AKI in two international clinical trials across 29 sites with more than 1200 patients combined. It is the only test that can accurately measure two biomarkers of kidney stress, TIMP-2 and IGFB-7. When these proteins are elevated, which can happen without any signs or symptoms, it indicates kidney stress before kidney damage has occurred and is highly predictive of which patients are most likely to develop AKI, if interventions are not started quickly.

How VITROS^® Optimizes the NEPHROCHECK^® Test

The proprietary technologies and benefits available only on the VITROS^® systems include Intellicheck^®, which monitors, verifies and documents diagnostic checks throughout sample assay processing to prevent reporting results that may be affected by exceptions; MicroSensor, which detects endogenous interferences and flags affected results without the use of reagents or extra consumables to verify the integrity of processed samples; MicroWell, which combines with the Enhanced Chemiluminescence Detection Technology to improve signal detection with outstanding precision and a wide dynamic range; and lastly, VersaTip, which helps eliminate carryover and cross-contamination by using disposable tips.

About Ortho Clinical Diagnostics

Ortho Clinical Diagnostics is a global leader of in vitro diagnostics serving the clinical laboratory and immunohematology communities. Across hospitals, hospital networks, blood banks and labs in more than 120 countries, Ortho’s high-quality products and services enable health care professionals to make better-informed treatment decisions. For the immunohematology community, Ortho’s blood typing products help ensure every patient receives blood that is safe, the right type and the right unit. Ortho brings sophisticated testing technologies, automation, information management and interpretation tools to clinical laboratories around the world to help them run more efficiently and effectively and improve patient care. Ortho’s purpose is to improve and save lives with diagnostics, and it does that by reimagining what’s possible. This is what has defined Ortho for more than 75 years, and it’s what drives Ortho forward. For more information, visit www.orthoclinicaldiagnostics.com.

© Ortho Clinical Diagnostics 2017

1. Ronco C, Ricci Z. Critical Care. 2013;17:117.
2. Kellum JA, et al. Nephrol Dial Transplant. 2016;31(1):16-22.
3. Ali T, Khan I, Simpson W, et al. Incidence and Outcomes in Acute Kidney Injury: a Comprehensive Population-Based Study. J. Am. Soc. Nephrol. 2007;18(4):1292-1298.
4. Mandelbaum T, Scott D, et al. Outcome of Critically ill Patients With Acute Kidney Injury Using the AKIN Criteria. Crit Care Med. 2011;39(12)2659-2664.