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Development of First Gen Oxalate Monitoring Test

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43DK121658-01
Agency Tracking Number: R43DK121658
Amount: $149,676.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: 300
Solicitation Number: PA18-574
Solicitation Year: 2018
Award Year: 2019
Award Start Date (Proposal Award Date): 2019-05-01
Award End Date (Contract End Date): 2020-04-30
Small Business Information
12085 RESEARCH DR, RM 155
Alachua, FL 32615-6837
United States
DUNS: 080218765
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (352) 317-8966
Business Contact
Phone: (954) 300-7469
Research Institution

ABSTRACT Hyperoxaluriadefined as the presence of excess oxalic acid and or oxalate salts in urinary excretionsis a physiological condition associated with an increasing number of common and debilitating chronic diseases whose prevalences are increasing in both the United States and the rest of the worldOxalic acid is a natural and abundant by product of metabolismbut also a highly oxidized organic compound with powerful chelating activity thatin high concentrationscan cause death in both animals and humans due to its corrosive effectsMore commonlyhoweverhyperoxaluria is now associatedor correlatedwith a variety of pathological disordersincluding cardiomyopathycardiac conductance disordersurolithiasisfungal infectionscystic fibrosiscolitisprimary hyperoxaluria type Ipyridoxine deficiencyand steatorrheaThusregulating oxalate levels in the body is receiving greater recognition as an important factor in controlling the effects of hyperoxaluria in multiple pathologiesUnfortunatelycurrent testing for hyperoxaluria is expensivetimeconsuming and mainly conducted by trained technicians in well equipped laboratoriesThis SBIR proposal addresses a serious issue in the field of hyperoxaluria associated pathologiesthe lack of a simplerapid pointof care device to monitor oxalate levels in biological fluidsTo address this deficiencywe propose to complete the development of a dipstick test that rapidly and accurately measures oxalate levels in urineTo obtain proofof conceptthe team proposes the following Phase I Specific AimsDevelop a dipstick test from which results can be obtained by visual readingandPerform in vitro testing of the dipsticks to determine the sensitivityspecificityaccuracyand reproducibilityDevelopment of a dipstick for quantifying changes in oxalate levelssimilar to the glucometer for measuring glucose levelswould represent a unique advancement for patients suffering with diseases ranging from calcium oxalate kidney stone disease to cystic fibrosis and primary hyperoxaluria typeOur preliminary data suggest the stated aims will be readily achievedOnce proof of concept is confirmedthe team will move into Phase IIwhich will focus on clinical functionality and performance of the dipstick PROJECT NARRATIVE Oxalic acid is a naturally occurring substance thatin high concentrationsis toxic to most organismsElevated levels of oxalic acid in urinereferred to as hyperoxaluriahave been found to be present in a number of pathological conditionsincluding kidney stone diseaseprimary hyperoxaluria type Icardiomyopathyand vulvar painUnfortunatelymeasurement of oxalate is time consuming and highly technical requiring skilled technicians and sophisticated equipmentthuspatients and physicians are usually unable to quickly obtain urinary oxalate levels reducing patient physician during visits as a mean to adjust or recommend dietary changesThis SBIR focuses on the development of a urine dipstick that will permit rapid simple point of care measurements of oxalate

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

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