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Study Suggests that NGAL Identifies Acute Kidney Injury Early in ICU Patients

WALTHAM, Mass., Oct. 5 /PRNewswire-FirstCall/ -- According to a new study now available online, and to be published in an upcoming issue of the Journal of Critical Care, bedside testing for a blood biomarker called neutrophil gelatinase-associated lipocalin (NGAL) in patients being admitted to the intensive care unit can help to identify patients at risk for acute kidney injury (AKI). The study tested blood samples collected during the first 2 hours of ICU admission using the Triage® NGAL Test, a product currently sold by Inverness Medical Innovations, Inc. (NYSE: IMA) outside of the United States.*

Many patients admitted to the ICU will suffer from acute kidney injury, some of whom will ultimately lose kidney function entirely and develop the need for renal replacement therapy (dialysis). When this occurs mortality rates are extremely high. Today, by the time that AKI has been detected by standard clinical measures, a substantial portion of renal function may already have been lost and interventions may not have much effect on the patient's outcome.

However the study suggests that a rapid test for NGAL could allow clinicians to rapidly assess if a critically ill patient is suffering from AKI perhaps in time to make meaningful interventions.

In this study, researchers at the University Hospital of Clermont-Ferrand, France, found that critically ill patients being admitted to the ICU with an elevated blood NGAL level were very likely to suffer from AKI. Using a cut-off level of 150ng/mL for blood NGAL, the sensitivity and specificity to predict AKI were 82% and 97%, respectively.

Measuring blood NGAL with a simple beside test allows for immediate results and early identification of AKI which was only realized by traditional clinical markers of AKI 48 hours after the NGAL increase, according to this study.

"A bedside blood test like this could be tremendously important for critically ill patients. So far therapeutic interventions for patients with AKI have been relatively unsuccessful. This is likely because they are applied late once kidney function is already lost. Knowing which patients are in trouble in advance may allow clinicians to choose therapies that will minimize further harm to the kidneys and may allow for the study of new therapeutic interventions. If further studies confirm our hypothesis, this bedside blood test could become the corner stone of a new therapeutic age," said Dr. Jean-Michel Constantin of the University Hospital of Clermont-Ferrand.

Considering the US, EU and Australia/New Zealand alone, Inverness estimates that in 2008 approximately 2.4 million patients at high risk of AKI were admitted to ICUs. Subject to confirmation through future trials, Inverness also expects the Triage NGAL Test to offer similar diagnostic benefits in hospital emergency rooms.

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

*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.

SOURCE Inverness Medical Innovations, Inc.
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