PreQuine Platform; A novel point of care device for the diagnosis and monitoring of Glucose-6-Phosphate Dehydrogenase (G6PD)

Grant Number: 2SB1AI129057-04
Grant Agency and Type: NIH NIAID
Amount: $ 2,893,164
Principal Investigator: Robert Harper
Disease Indication: G6PD

Commercialization Readiness Pilot (CRP) program aims to facilitate the transition of previously or currently funded SBIR projects to the commercialization stage by providing additional support for technical assistance and later stage research and development (R&D) not typically supported through Phase II or Phase IIB grants or contracts.

The goal of this CRP SBIR project is to complete development and prepare for clinical trials and commercialization of the PreQuine Platform, a novel, point of care diagnostic test for simultaneous quantification of G6PD and Hgb for patients diagnosed with malaria and patients suffering from acute anemia. Malaria caused by Plasmodium vivax and plasmodium oval threatens over 2 billion people globally and sickens tens of millions annually.  While treatments such as primaquine and tafenoquine can provide a cure, over 8% of the global population is contraindicated due to inherited Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency. When administered in these individuals, these malaria treatments can cause serious, and often life-threatening issues.

Currently care providers mostly use rapid diagnostic tests (RDTs) for semi-quantitative determination of G6PD followed by a separate device for measuring Hgb levels which leads to inaccurate determinations of G6PD units. The innovative PreQuine Platform combines a single (dual analyte) test trip and meter for the simultaneous quantitative determination of hemoglobin (Hgb) and G6PD. Successful commercialization of an accurate, low cost and accessible, detection platform would globally transform malaria care, especially in underserved populations.

Successful commercialization and wide scale adoption of the PreQuine Platform requires additional technical accessories and supporting infrastructure including optimized meter development, validation, software mobile app development and validation, and system packaging.

With the support of CRP to commercialize the PreQuine platform IVDS will:
1- Complete Development of System Level Technology and supporting Infrastructure.
2- Develop Regulatory Strategy Roadmap and Implement Quality System Requirements.
3- Enhance Quality Management System and Manufacturing Infrastructure.
4- Conduct Market Research and Develop Intellectual Property Strategy, Including Analysis of the Patent Landscape in the US and Abroad.
5- Device Production and Multicenter Clinical Study Validation (Not Clinical Trials)
6- US FDA 510 Submission

IVDS develops novel testing technologies for the healthcare, veterinary, and consumer markets. IVDS scientists have helped bring 10 FDA-approved products to market over their careers in diagnostics.
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