GODX INC — Department of Health and Human Services SBIR Phase I: NIAID

Description

Project Summary AbstractWorldwide more than a million newborn babies die each yearmostly in the developing worlddue to serious bacterial infectionstypically sepsis or commonly known asblood poisoningThe diagnosis of neonatal sepsis remains challenging since many infants show subtle and nonspecific clinical signsDue to the fear of missing a positive diagnosisthe established clinical practice in US and many developed countries is to conductrule outtestswhich are impreciseinvasiverequiring large blood sample draws and are costlyMost of allthese tests prove unnecessary for the vast majority of infantswho do not have sepsisrather may present with other neonatal disease processes that mimic sepsisA related and widespread practice for the samerule outreasons is the accompanying prescription of antibioticswhich in the short or long run can harm the baby or render it resistantImportantlycurrent diagnostic lab tests can take more thandays and have a high percentage of either false positives or negatives due to poor sensitivity and specificityGoDx proposes to develop in this Phase I SBIR project a novellow costpaper basedand highly sensitive point of care diagnostic test that promises to significantly advance and improve the standard treatment paradigm for neonatal sepsisTo prove the feasibility of developing such a testwe will aim to establish important performance benchmarks and demonstrate superior blood sepsis biomarker detectionWe will focus on the evaluation of a proprietary combination of biomarkerswhich have shown promising results in our preliminary workThe resulting manufacturing process of our diagnostic tool will be uniquely simple and low cost so that it is ideal for use in the developing world where inadequate infrastructure prohibits the use of more complex lab test dependent on electricity and expensive specialized instrumentationWhen successfully completedwe hypothesize that our test will be able to detect sepsis specific biomarkers withspecificity andsensitivity within less thanminutesDevelopment of the multiplexed paper strip test in this projectwill position GoDx for prototyping and optimization of the prototype in Phase II!Project Narrative We are developing a rapidlow costpoint of carepaper based screening test for the detection of sepsis which claims the lives ofmillion newborns worldwidemostly in the developing world with limited resourcesOnlyof theill appearing babies evaluated each day for sepsis in the U Sultimately prove to have a serious bacterial infectionOur test will save costs to healthcare because medical providers will be able to quickly determine which infants are at very low risk of infection and avoid running expensive and invasiverule outtests such as lumbar puncturespinal tapdecrease antibiotic utilizationand minimize unnecessary hospitalization