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Low cost point-of-care diagnostic to address community vitamin D health disparities

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43MD013409-01A1
Agency Tracking Number: R43MD013409
Amount: $219,204.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: 102
Solicitation Number: PA18-574
Timeline
Solicitation Year: 2018
Award Year: 2018
Award Start Date (Proposal Award Date): 2018-09-21
Award End Date (Contract End Date): 2019-08-31
Small Business Information
3900 ESSEX LN STE 575
Houston, TX 77027-5175
United States
DUNS: 079204766
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 MICHAEL HEFFERNAN
 (281) 615-4704
 michael@fannininnovation.com
Business Contact
 TIFFANIE JOHNSON
Phone: (713) 579-0073
Email: tiffanie@fannininnovation.com
Research Institution
N/A
Abstract

PROJECT SUMMARYEpidemiologic and randomized clinical studies suggest that low vitamin
D levels are associated with decreased bone mineral density and increased fracture riskAdditionallyvitamin D plays a major role in various metabolic processes and deficiency has been
implicated in childhood ricketsosteoporosistype II diabetesand a variety of cancersSincevitamin D levels have been decreasing across the U Spopulationby approximatelyThere is a significant disparity in vitamin D status among non Hispanic BlacksMexican
Americansand non Hispanic whites in the United Stateswith non Hispanic Blacks having the
highest prevalence of vitamin D deficiencyandltng mlfollowed by Mexican AmericansBoth
groups also have a higher prevalence of vitamin D inadequacyng mlthan non Hispanic
whitesRandomized clinical trials have shown that adequate vitamin D intake through dietary
supplementation in populations at risk for nutritional deficiency can prevent fragility fractures and
may improve metabolic disease outcomeSupplementation is thus an easy and inexpensive
mode of treatmenthoweverthere does not currently exist a point of carecost effective method
of measuring a patient s vitamin D statusSerum vitamin D is measured clinically using platebased enzyme linked immunosorbent assayELISAtestswhich can take one to three hours and
require a laboratory settingBreviTest Technologies LLC is developing a portable analyzer to
perform a rapidquantitative ELISA test within aminute run timeThe sample is loaded into a
microfluidics cartridgeand an automated mechanism controls the movement of antibodyconjugated magnetic nanoparticles through successive fluid wellswhere enhanced mixing
patterns substantially reduce the time required for each ELISA stepThis innovative approach
enables the implementation of a rapidportablefully automated ELISA test with accuracy
comparable to a standard laboratory ELISAIn this SBIR Phase I projectwe will perform the
following specific aimsDevelop and optimize a rapid ELISA assay for total vitamin D using
the BreviTest portable analyzerandPerform proof of concept testing to detect total vitamin
D in simulated blood samples using the BreviTest portable analyzerDeployment of a point ofcare vitamin D test in retail pharmacies and health clinicsparticularly in at risk communitieswill
enable easy assessment of vitamin D statuswhich will facilitate targeted dietary supplementation
to address vitamin D deficiency in underserved populations PROJECT NARRATIVEThere is a significant health disparity in vitamin D levels across the USwith nonHispanic Blacks having the highest prevalence of vitamin D deficiency followed closely by Mexican AmericansLow vitamin D levels are associated with decreased bone mineral densityincreased fracture riskosteoporosisand a variety of cancersDeficiency is easily treatable with dietary supplementationhoweverthere does not
currently exist a point of carecost effective method of measuring a patient s vitamin D statusIn this SBIR Phase
I projectBreviTest Technologies proposes to developoptimizeand conduct proof of concept studies for an
affordable and quick vitamin D assay that can be used in retail pharmacies and health clinics for easy
assessment of vitamin D status

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

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