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Second Study Supports that NGAL Test Identifies Acute Kidney Injury Early in Critically Ill Patients

Friday, December 18, 2009 Research News J E 4
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WALTHAM, Mass., Dec. 17 /PRNewswire-FirstCall/ -- According to a new study published last week in Intensive Care Medicine, a novel bedside blood test measured in critically ill patients being admitted to the intensive care unit can help to identify which patients are at risk for acute kidney injury (AKI). The study carried out in Vicenza, Italy, tested blood samples collected during admission to the ICU using the TriageŽ NGAL Test, a product currently sold by Inverness Medical Innovations, Inc. (NYSE: IMA) outside of the United States.*  

AKI is a common and often devastating complication for up to 25% of critically ill patients admitted to the ICU.  AKI can lead to increasing hospital length of stay and associated costs, and also increases risk of death.  AKI is often detected too late into its clinical progression when a substantial portion of kidney  function may already have been lost and the window for initiating treatment to prevent further harm has closed.

Earlier this year a small study conducted at the University Hospital of Clermont-Ferrand, France and published in the Journal of Critical Care found that a new bedside blood test for a blood biomarker called neutrophil gelatinase-associated lipocalin (NGAL) offered the promise of rapidly assessing if a critically ill patient is suffering from AKI.  Now results from the prestigious Department of Nephrology at San Bortolo Hospital in Vicenza Italy have confirmed these findings in a larger study published this week in Intensive Care Medicine.

In this study of 301 critically ill patients, plasma NGAL measured with the Triage NGAL Test was a statistically significant diagnostic marker for AKI development within the next 48 hours (area-under-ROC 0.78), and for renal replacement therapy use (area-under-ROC 0.82).   Moreover, peak plasma NGAL concentrations increased with worsening AKI severity (R=0.554, p<0.001).

"We are living in an exciting era where it seems possible to diagnose AKI much earlier than before thanks to NGAL, a new promising biomarker of kidney damage.  This may contribute to have a diagnosis in place, especially in the area of critically ill patients where an early detection of kidney insult may allow to stop harmful interventions or to install preventive /protective therapies that before were precluded or not indicated." said Prof. Claudio Ronco of the San Bartolo Hospital in Vicenza where the study was conducted.

Inverness supplied the Triage NGAL Tests used in the study at no charge, but did not otherwise fund or sponsor the study.

About Inverness Medical Innovations

By developing new capabilities in near-patient diagnosis, monitoring and health management, Inverness Medical Innovations enables individuals to take charge of improving their health and quality of life.  Inverness' global leading products and services, as well as its new product development efforts, focus on infectious disease, cardiology, oncology, drugs of abuse and women's health. Inverness is headquartered in Waltham, Massachusetts.

For more information about Inverness Medical Innovations, please visit our website at

http://www.invernessmedical.com.

*The Triage NGAL Test is not currently available for purchase or use in the United States.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the federal securities laws, including statements regarding the expected benefits, and the potential market for, the Triage NGAL Test. These statements reflect Inverness' current views with respect to future events and are based on management's current assumptions and information currently available. Actual results may differ materially due to numerous factors, including without limitation, the potential market acceptance of the Triage NGAL Test or other NGAL tests; the ability of Inverness to successfully develop and commercialize such products; the impact of regulatory changes or developments; the development and commercialization by others of competing products or alternative technologies; the ability of Inverness to supply sufficient quantities of the product; conditions in the financial markets; the intensely competitive environment in Inverness' markets it products, and the risks and uncertainties described in Inverness' annual report on Form 10-K, as amended, for the year ended December 31, 2008, and other factors identified from time to time in its periodic filings with the Securities and Exchange Commission. Inverness undertakes no obligation to update any forward-looking statements contained herein.

SOURCE Inverness Medical Innovations, Inc.

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