Ortho Clinical Diagnostics' VITROS NephroCheck test available in Europe

Published: 16-Jun-2017

CE Mark clearance for first fully-automated risk assessment tool for predicting Acute Kidney Injury (AKI)

Ortho Clinical Diagnostics has 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 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, causing as many as two million deaths annually worldwide.

AKI is caused by renal stress contributed to by major surgery, drugs, toxins, serious infection, or chronic illness and trauma.

Up to 50% of patients in intensive care develop some stage of AKI.

“Preventing AKI is one of the biggest unmet clinical and economic needs in health care globally,” said Claudio Ronco, director of the 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 maximises 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 1,200 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.

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 VersaTip, which helps eliminate carryover and cross-contamination by using disposable tips.

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