Infections are a leading cause of mortality in adult and pediatric ICUs. Earlier diagnosis and treatment of infection could significantly reduce patient morbidity and mortality. Unfortunately, current methods of detection cannot routinely detect infection early in the disease course. Isomark has developed a breath-based early detection technology (biomarkers and instruments for detection) that can pinpoint the onset of acute phase response (APR) to infection enabling earlier diagnosis/treatment. Infections in hospitalized patients lengthen hospital stays-a major expense. Isomark's overarching goal for this project is to commercialize its compact breath analyzer and patented method for monitoring breath for changes indicative of the onset of infection. This technology will aid in early detection of infections in high-risk intensive care unit (ICU) patients. Isomark has developed a noninvasive marker for monitoring patients at high risk of developing infections. In preclinical studies, Isomark's technology effectively detected the onset of the APR to infection via breath delta values (BDV) as early as 2 h after endotoxemia onset. In a preliminary clinical study (33 adult and pediatric patients), Isomark's technology detected the onset of APR to infection in 2 patients who acquired infections fully 24 h before doctors suspected infection. Based on these data, Isomark's breath analysis will provide clinicians a new physiological marker of the APR to infection that will aid i earlier diagnosis. In this Fast-Track project, Isomark scientists and engineers will work with strategic partner Picarro Inc. (Picarro;Santa Clara, CA;see Letters of Support) to develop a miniaturized point of care (POC) BDV monitor that easily attaches to existing mechanical ventilator equipment and monitors for changes in breath that indicate the APR to developing infections. In phase I, a team consisting of Isomark staff and engineers at strategic partner Picarro will develop a novel method of cavity enhanced spectroscopy, based on free spectral resonance of the gas cell, for BDV measurement in human breath that is miniaturizable and less expensive that current technologies. Isomark will also produce a prototype device and graphical user interface. In phase II, Isomark will miniaturize the device and integrate the graphical user interface. Isomark will validate that the product performs to expected specifications in the clinicl setting by performing an animal study of sepsis in mechanically ventilated swine. Finally, Isomark will produce a prototype device and device design file to facilitate regulatory approval of the device. The successful completion of this project will result in a the Isomark CanaryPOC BDV monitor capable of real- time detection of the acute phase response to infection in mechanically ventilated patients. The Phase I project will demonstrate proof of principal for this new measurement technique. In phase II, Isomark will construct the final prototype device and validate that it functions as espected. In phase III, Isomark will perform clinical trials for FDA clearance of the new incubator for early detection of sepsis, and then begin marketing the device.

Public Health Relevance

of this project will lead to a new point of care device for earlier detection of the acute phase response to infection in mechanically ventilated patients. Products developed in this project will lead to reduced need for unnecessary treatment, treatment of illnesses before they become critical, and a reduction of lifelong consequences of critical illness due to the acute phase response to infection in mechanically ventilated patients.

National Institute of Health (NIH)
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
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Special Emphasis Panel (ZRG1)
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Cole, Alison E
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Isomark, LLC
United States
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