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Rapid Test to Assist Therapy in Neonatal Sepsis and Necrotizing Enterocolitis

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 4R44AI141283-02
Agency Tracking Number: R44AI141283
Amount: $1,000,000.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: R
Solicitation Number: PA17-302
Solicitation Year: 2017
Award Year: 2019
Award Start Date (Proposal Award Date): 2019-05-03
Award End Date (Contract End Date): 2021-04-30
Small Business Information
349 EDDY ST, Providence, RI, 02903-4204
DUNS: 140315248
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 (401) 301-2046
Business Contact
Phone: (401) 301-2046
Research Institution
The primary goal of this proposed research is to develop a rapid point of care test that assesses the risk of neonatal sepsisNSand or necrotizing enterocolitisNECin infants based on Inter alpha inhibitor proteinsIAIPlevels in bloodThe test is expected to be simpleuser friendlyportable and suitable for use in the NICUNS and NEC are associated with high mortality and morbidityincluding adverse neurodevelopmental outcomesFurthermoreboth conditions are associated with systemic inflammatory responses and their initial clinical presentations are similarnon specific and subtle leading to a greater likelihood for misdiagnosisIt is important for clinicians to discern which patients are at risk for progressing to NEC or NS as clinical deterioration in both diseases can progress in a fulminant manner resulting in shock and death within hours of clinical presentationThere is currently no sensitive and specific test for early detection of NS and NECIAIP are found in plasma at a relatively high concentration and play an important role as innate immunity proteins to modulate host inflammatory response to pathological insultsDuring acute systemic inflammation following severe infectiontrauma and injurythese proteins are rapidly depleted leading to a rapid decrease in plasma levelsWe previously reported that IAIP levels are significantly decreased in adult sepsis and in infants with NS and NECIn our recently completed studieswe confirmed that IAIP level is a sensitive and specific predictive marker for NS and NEC and more remarkablythe IAIP test has excellent high negative predictive value in both NSand NECindicating that this test is potentially useful to influence the judgment on whether or not to discontinue antimicrobial treatment when the conventional tests are uninformativeFurthermoreour results demonstrated that it is feasible to develop a quantitative lateral flow based test that is capable of measuring IAIP withinminwhich is comparable to the results obtained by ourhrlaboratory based competitive ELISAR andgtIn this proposalwe will extend these studies to improve the rapid assay design and further optimize the prototype test toward a fully developed product through design verification and design validation using clinical samples collected from infants suspected with NS and NEC at multiple clinical sitesThe specific aims of the Fast track SBIR project areFeasibility study to convert the competitive rapid lateral flow assay to a more robust and improvedsandwichrapid IAIP assay formatDesign verification study of the lateral flow IAIP rapid testIntegration of the IAIP rapid test strip with the reader system andCross verification studies of the IAIP rapid test performance and confirmation studies of its predictive value using collected clinical samplesThese studies are designed to obtain a robust and fully developed prototype test that is ready to enable future studies required for regulatory approval by the FDAThe impact of this project is immense as the rapid test will help reduce the high morbidity and mortality associated with the devastating diseases of NS and NEC as well as support antibiotic stewardship in infants The goal of this proposed research is to develop a rapid test based on Inter alpha inhibitor proteins that can be useful to detect infants with life threatening conditions such as whole body infectionsepsisand necrotizing enterocolitis using a simpleportable device suitable for a bedside testingThe potential impact of the proposed research is immense as it will reduce the devastating effects of these diseases

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

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