Quantcast

Industry news that matters to you.  Learn more

Astute Medical to Release First Test for Risk Assessment of Kidney Injury

A novel test used to assess risk for acute kidney injury (AKI) could help physicians significantly improve management of intensive care unit (ICU) patients at risk for AKI, who annually account for 5 million admissions.[1] Inadequacies in assessment and management of AKI have been cited as contributing to an increased number of deaths and excess healthcare costs.[2-3]

Study Expands Use of Biomarker for Early Diagnosis of Acute Kidney Injury

A biomarker test developed initially to identify early acute kidney injury (AKI) after surgery has been shown to successfully detect AKI in emergency room patients with a variety of urgent health issues.

In a study published online Sept. 5 in the Clinical Journal of the American Society of Nephrology, the findings expand the overall utility and potential medical settings for using the test, according to researchers.

The test measures the protein neutrophil gelatinase-associated lipocalin (NGAL) as a biomarker of early AKI. It was invented by researchers at Cincinnati Children’s Hospital Medical Center to detect AKI earlier than existing methods, and to more promptly begin treatment.

“The majority of our studies on NGAL have been performed in well controlled settings of hospital-acquired AKI, such as cardiac surgery, contrast administration or other critically ill patients,” said Prasad Devarajan, MD, senior author and director of Nephrology and Hypertension at Cincinnati Children’s. “The purpose of this study was to determine the biomarker’s accuracy in a diverse group of patients admitted from the emergency department, where patients with early signs of AKI are often misdiagnosed.”

The study involved patients admitted through the emergency room of Fernando Fonseca Hospital in Portugal, which also closely collaborated on the study. The findings demonstrate the NGAL test, which uses a single drop of blood and provides results within 15 minutes, was able to accurately distinguish AKI from reversible transient kidney dysfunction.

Of 616 patients who participated in the study, individuals who were subsequently diagnosed with true AKI had the highest levels of NGAL detected at the time of hospital admission. The study also identified a cutoff point in NGAL levels above which the risk of acute kidney injury increases tenfold.

Results of a study previously published in 2008 by Devarajan showed that the NGAL test predicted AKI in pediatric heart surgery patients within hours instead of days, allowing treatment that prevented serious damage to kidneys. Prior to the NGAL test, serum creatinine was the only reliable method for detecting kidney damage; however, the long wait for results often resulted in permanent kidney damage.

With a growing number of patients coming to emergency rooms with community-acquired AKI, Devarajan says having a rapid, reliable method of detecting kidney injury is increasingly important.

“This latest study showed that this simple laboratory test provides an accurate prediction of acute kidney injury and its severity in a diverse clinical setting,” said Devarajan. “The identification of biomarkers that differentiate intrinsic AKI from transient reversible forms of renal dysfunction and predict outcomes is a high priority.”

Study: Plasma NGAL for the Diagnosis of AKI in Patients Admitted from the Emergency Department Setting [Clinical Journal of the American Society of Nephrology]

Source: EurekAlert!

Astute Medical, Inc. Advancing Next Generation Acute Kidney Injury Biomarkers

Citing results of a clinical study published recently in Critical Care, Astute Medical Chief Executive Officer Chris Hibberd said he is confident about the prospects for newly validated biomarkers of kidney damage used in the Company’s NephroCheck(®) Test. The international, multi-center study validated the ability to predict acute kidney injury (AKI) using measurements of the two biomarkers, Insulin-like growth factor-binding protein 7 (IGFBP7) and tissue inhibitor of metalloproteinases-2 (TIMP-2) and demonstrated their superiority in risk assessment of AKI when compared with existing biomarkers.

Astute Medical Announces Launch of Nephrocheck Test

Astute Medical, Inc. yesterday announced it has completed CE mark certification for its first product, the Nephrocheck™Test, and is commencing sales. The Nephrocheck™ Test utilizes two newly validated urinary biomarkers for risk assessment of acute kidney injury (AKI) in critically ill patients. The Nephrocheck™ Test is not available for sale in the United States.

EKF Diagnostics Signs Licensing Agreement for Kidney Biomarkers

EKF Diagnostics Holdings plc (AIM: EKF), a worldwide manufacturer of point of care in-vitro diagnostic devices, announces that it has signed an exclusive license agreement with the Joslin Diabetes Center (“Joslin”), a teaching, research and clinical care affiliate of Harvard Medical School, to license certain novel kidney biomarker technology. The licensed biomarkers were developed by Dr. Andrzej Krolewski, MD, PhD, Head of Section on Genetics and Epidemiology, and his laboratory team at Joslin.