MBIO DIAGNOSTICS INC — Department of Health and Human Services SBIR Phase I: 200

Description

Sepsis is a devastating cause of morbidity and mortality in intensive care units ICUs with estimates of U S incidence ranging from to million cases annually The heterogeneity of clinical presentation etiology patient history severity etc creates a major challenge for patient management and has significantly complicated development of new therapies almost all of which have failed to show significant benefit Because of its high incidence and high cost of treatment sepsis imposes a heavy financial burden on the health care system A prognostic test that stratifies diagnosed patients by baseline mortality risk would improve patient care and reduce expenditures by directing resources to those patients most at need MBio Diagnostics is proposing a SBIR research program in collaboration with the Cincinnati Childrenandapos s Hospital Medical Center CCHMC designed to translate the multi biomarker pediatric sepsis mortality risk algorithm PERSEVERE to the MBio point of care platform The MBio platform is unique in its ability to deliver a panel of quantitative immunoassay results from an easy to use single use cartridge and portable reader Under this Phase I SBIR MBio will establish feasibility of the point of care sepsis tool by developing the plex immunoassay on the MBio platform and then validating on a set of clinical samples Specific aims are to Deliver a multiplexed sandwich immunoassay on the MBio cartridge and reader platform that combines heat shock protein HSPA B Matrix metalloproteinase MMP Interleukin IL C C chemokine ligand CCL and Granzyme B GZMB Combine the detection antibody combination from Aim into an on cartridge lyophilized formulation to establish feasibility of a single user interaction assay workflow and Validate the MBio plex assay by evaluating a set of up to clinical plasma samples sourced from the CCHMC sample repository MBio has outstanding preliminary data showing that its platform delivers a unique and important assay solution in a format compatible with point of care implementation in the ICU With clinical guidance and the characterized sample repository contributed by program collaborator Dr Hector Wong this Phase I research program is an important first step toward a high clinical need tool for sepsis patient management The outcome of the proposed research program will be a multi biomarker assay system that provides rapid classification of mortality risk in pediatric sepsis patients The same platform can be expanded to include biomarkers for adult sepsis classification A successful research program will produce a product with broad applicability for acute disease management