Pragma Health Corp. — Department of Health and Human Services SBIR Phase I: NICHD

Description

PROJECT SUMMARYApproximatelyof couples trying to become pregnant will not conceive aftermonthsThe resulting infertility diagnosis and treatment regimen can be overwhelming to patientsStudies have shown that up toof enrollees will discontinue treatment before achieving a pregnancythey often cite physical and emotional burdenlogistical concerns with repeated clinic visitsand cost as reasons for ending their treatmentAt home diagnostic tests that measure key reproductive endocrinology biomarkers have the potential to remove many of these burdensUnfortunatelyexisting at home tests provide clinical utility to very limited use cases becausethey only measure one or two relevant biomarkersthey require qualitative subjective analysisthey return results too slowlyIn this researchwe propose the development of Barcode Embedded Rapid Diagnostic TestsBERDTsas an at home test to measure fertility hormones in urineThese tests have novel spatial patterning of reagents that allows them to be automatically and quantitatively analyzed by a mobile phone applicationOnce results are determined on the patient s phonethe application can provide clinical decision support as well as securely share the test results with the patient s clinician through electronic medical recordsEMRWe have assembled an interdisciplinary consortium that consists of biomedical engineeringpoint of care deviceand software development expertisePragmaDxIncbiomarker assay development in the Department of Chemistry at Vanderbilt Universityand clinical reproductive endocrinology and infertility expertise at Vanderbilt University Medical CenterTo meet our shared goalsour specific aims willoptimize manufacturing conditionsdevelop and evaluate mobile phone and server side softwareand rigorously compare the performance of BERDTs to standard clinical laboratory methods using de identified patient specimensA successful outcome of this Phase I SBIR will be the development of a diagnostic test and mobile phone software that is capable of measuring multiple hormones in urine at the point of carewith accuracy comparable to standard clinical laboratory assaysIt will be ready for a rigorous clinical evaluationwhich will be the subject of a Phase II SBIR application PROJECT NARRATIVEMore thanof couples trying to conceive will not become pregnant within one yearWhile treatments can be effectivethere are substantial logistical and financial barriers that prohibit enrollment in these servicesAccurate at home hormone measurements have the potential to allow these services to reach broader use