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

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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.

The NephroCheck(®) Test is intended to aid in the risk assessment of AKI, a condition as prevalent and more deadly than heart attack. The test was launched in Europe in October 2012. It is not available for sale in the United States.

Much like a silent heart attack, AKI can strike without obvious symptoms. The condition is associated with high mortality rates, in part, because it often is not detected until it has reached the later stages when few management options exist.

“If unchecked, AKI can lead to loss of kidney function, often resulting in lower quality of life or even death,” said Dr. John Kellum, a critical care physician at UPMC and principal investigator for the study. “Our data show that two urinary biomarkers of kidney damage can tell a doctor if a patient is at risk for AKI. In addition, these biomarkers provide additional information over clinical variables and add mechanistic insight into AKI, making them the most promising markers of AKI reported to date.”

Researchers reported on a two-part study that initially evaluated 340 biomarkers and found the combination of TIMP-2 and IGFBP7 to have the highest correlation with risk of AKI. Results from the second part of the study validated the utility of TIMP-2 and IGFBP7 and the improved ability of the two-biomarker combination to predict AKI when compared to existing biomarkers.

“Based upon these results, we believe the NephroCheck(®) Test will be able to help physicians address one of the most costly, deadly and confounding conditions affecting intensive care hospital patients,” said Hibberd. “With increasing constraints on healthcare spending, innovative tools such as the NephroCheck(®) Test will be essential to ensuring that the right resources get to the right patients at the right time.”

AKI has been associated with higher cost of care, especially in the intensive care unit (ICU). A 2008 study of post-cardiac surgery patients published in Nephrology Dialysis Transplantation reported that critically ill patients with no AKI had an ICU cost of $13,836 and 1.4 days of length of stay. In comparison, patients with severe AKI had an ICU cost of up to $49,328 and up to 5.4 days of length of stay.

AKI affects up to seven percent of hospitalized patients. The incidence is much higher among critically ill patients, with up to half developing some degree of AKI during their illness.

Study: Discovery and validation of cell cycle arrest biomarkers in human acute kidney injury

Source: Astute Medical