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Two Contracts for Sepsis Test Development Announces MBio Diagnostics

Sepsis tests will be developed in collaboration with the Cincinnati Children’s Hospital Medical Center and The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. o address the critical need for more effective sepsis patient management in clinical and field settings

MBio Diagnostics, Inc.,announced two new contracts for sepsis test development. The first is a Phase II Small Business Innovative Research grant from the National Institutes of Health (NIH) focused on point-of-care implementation of the pediatric sepsis mortality risk algorithm developed at the Cincinnati Children’s Hospital Medical Center (CCHMC).

The second is from The Henry M. Jackson Foundation, Inc. (HJF) for the Advancement of Military Medicine for development of a field-forward 10-plex immunoassay for prediction of sepsis survival in areas where healthcare access is limited.

Sepsis is a devastating cause of morbidity and mortality; estimates of U.S. incidence range from 894,000 to 3.1 million cases annually. Because of its high incidence and high cost of treatment, sepsis imposes a heavy financial burden on the health care system. MBio’s NIH-funded program is in collaboration with Dr. Hector Wong, Director of Critical Care Medicine at CCHMC, whose group has developed a laboratory-based pediatric sepsis prognostic assay. “When managing care for these gravely ill children, we need test results at the bedside in minutes – not hours later in the laboratory,” said Dr. Wong. The CCHMC-MBio test combines five blood-based biomarkers with clinical inputs to quickly stratify patients by mortality risk. Dr. Wong added, “Phase I data on the MBio point-of-care platform showed excellent correlation with data we have been generating in the laboratory over the last several years. We are very excited about the prospect of getting this test into the ICU.”

MBio’s HJF contract is in collaboration with the Austere environments Consortium for Enhanced Sepsis Outcomes (ACESO). The ACESO project is sponsored by the Department of Navy, Naval Medical Research Center. The ACESO group has developed a laboratory-based sepsis management algorithm based on 10 blood biomarkers. The ACESO-MBio project will establish feasibility of quantitative detection of the 10 blood biomarkers on MBio’s simple-to-use, point-of-care device. “The ACESO sepsis tool requires measurement of multiple biomarkers in a single sample very quickly,” said HJF President and CEO Dr. Joseph Caravalho. “The MBio platform seems uniquely positioned to deliver the results we need in a format that can be effectively utilized in challenging field settings encountered in military medicine.”

MBio’s CEO Chris Myatt added, “In addition to the devastating health impacts of sepsis, the financial burden sepsis management places on the healthcare system is enormous. By providing timely results at the point-of-care, the MBio system has the potential to both improve patient outcomes and reduce the overall costs of sepsis management. We are grateful for the confidence the NIH and HJF have shown in our system.”

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