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Point-of-Care Prognostic Tool for Sepsis

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R44GM125418-02
Agency Tracking Number: R44GM125418
Amount: $471,444.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: 300
Solicitation Number: PA18-574
Solicitation Year: 2018
Award Year: 2019
Award Start Date (Proposal Award Date): 2019-07-01
Award End Date (Contract End Date): 2021-06-30
Small Business Information
5603 ARAPAHOE AVE STE 1, Boulder, CO, 80303-1377
DUNS: 961776577
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 (303) 952-2810
Business Contact
Phone: (303) 952-2810
Research Institution
Sepsis is a devastating cause of morbidity and mortality in intensive care unitsICUswith estimates of U Sincidence ranging fromtomillion cases annuallyThe heterogeneity of clinical presentationetiologypatient historyseverityetccreates a major challenge for patient management and has significantly complicated development of new therapiesalmost all of which have failed to show significant benefitBecause of its high incidence and high cost of treatmentsepsis imposes a heavy financial burden on the health care systemA 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 needMBio Diagnostics is proposing to build on a successful Phase I SBIR research programWorking in collaboration with the Cincinnati Childrenandapos s Hospital Medical CenterCCHMCthe program designed to translate the multi biomarker pediatric sepsis mortality risk algorithmPERSEVEREto the MBio point of care platformThe MBio platform is unique in its ability to deliver a panel of quantitative immunoassay results from an easy to usesingle use cartridge and portable readerUnder this Phase II SBIRMBio will establish feasibility of the point of care sepsis tool by developing theplex immunoassay on the MBio platform and then validating on a set of clinical samplesSpecific aims are toFinalize theplex PERSEVERE assay and establish the whole blood assay protocoldelivering a multiplexed sandwich immunoassay on the MBio cartridge and reader platform that combinesheat shock proteinHSPA BMatrix metalloproteinaseMMPInterleukinILC C chemokine ligandCCLand Granzyme BGZMBBuild a analytical performance dataset establishing assay analytical sensitivityprecisionand linearity using CLSI guidelinesValidate the MBioplex assay by evaluating a set of up toclinical serum samples sourced from the CCHMC sample repositoryandRun a prospective clinical sample evaluation including sepsis patients in an intended use setting at the CCHMC Pediatric Intensive Care UnitMBio has outstanding Phase I data showing that its platform delivers a unique and important assay solution in a format compatible with point of care implementation in the ICUWith clinical guidance and the characterized sample repository contributed by program collaborator DrHector Wongthis Phase II 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 patientsThe same platform can be expanded to include biomarkers for adult sepsis classificationA successful research program will produce a product with broad applicability for acute disease management

* Information listed above is at the time of submission. *

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