A user-friendly point-of-care device for G6PDH determination

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R44AI129057-02A1
Agency Tracking Number: R44AI129057
Amount: $873,090.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NIAID
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): 2021-04-30
Small Business Information
8 ABINGTON RD, Mount Laurel, NJ, 08054-4719
DUNS: 078783141
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 (856) 343-5098
Business Contact
Phone: (856) 343-5098
Email: invitrodiagnosticsolutions@gmail.com
Research Institution
Abstract Malaria caused by Plasmodium vivax threatens overbillion people globally and sickens tens of millions annuallyRadical cure for Pvivax malaria includes therapy aimed both at the acute attackblood schizontocidaland against future attackshypnozoitocidalThe only hypnozoitocides available areaminoquinolines such as primaquine or tafenoquineHoweverclinicians often do not prescribeaminoquinolines due to the high prevalenceof individuals with various levels of inherited Glucosephosphate dehydrogenaseG PDdeficiencies andaminoquinolines can cause life threatening acute hemolytic anemia in patients with moderate to severe G PD deficienciesThere are no commercially available point of carePOCtests that can quantify both Hgb and G PD from a finger stick sampleIn Phase Iwe successfully met the performance as outlined by the World Health Organization and the Program for Appropriate Technology in HealthPATHResults of whole blood and plasma testing revealed excellent concordance between our PreQuine System and current reference methodsIn Phase IIwe propose to manufacture a simple to use inexpensive devicethe PreQuine Systemthat can be used in the field or clinical settingwhich will have a number of valuable featuresFirstthe PreQuine System will be comprised of test strips and a hand held meter with an on board temperature correction algorithmSecondthe PreQuine System will be ruggedlow costand minimally invasive for broad use in clinical settingspublic health labs and targeted outreach programsTo complete development of the PreQuine Systemwe willFinalize Assay Development by Assessing Bioactive ComponentsThree commercially available diaphorases will be tested to ensurea high degree of activity at the optimal pHlong term stabilityandno inhibition in the presence of maleimideTransition from Hand Assembly to Semi Automated Assembly of Test StripsThis will be achieved by optimizing process capabilities of coatingslitting and laminating the strips intoup card stockIncorporate a Temperature Correction FactorTFCThe PreQuine system must be enable function in a working temperature ofC toCThe TFC will be incorporated into the software and correct for temperature differencesFinallyValidation of the PreQuine SystemValidation for G PD and Hgb levels will demonstrate concordance between the manufactured test strips and reference methodsOnce validated and commercializedthe PreQuine System will provide point of care diagnostic tool to identify G PD deficient individuals who can or cannot tolerateaminoquinoline treatmentwhich will transform malaria treatment strategies and aid in the eradication of P vivax and Povale malaria Project Narrative Malaria caused by Plasmodium vivax and POval threatens overbillion people globallyAlthough radical cure for Pvivax malaria includes administeringaminoquinolinesclinicians often do not prescribe these drugs due to the high prevalenceof individuals with various levels of inherited Glucosephosphate dehydrogenaseG PDdeficiencieswhich can cause life threatening acute hemolytic anemia in patients with moderate to severe G PD deficitsIn this Phase II applicationwe propose to complete the development effort and validate the performance of this point of care device for the diagnosis of G PD using CLSI guidelines

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

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