PreQuine Platform. A novel point of care device for the diagnosis andmonitoring of Glucose-6-Phosphate Dehydrogenase (G6PD)

Abstract Malaria caused by Plasmodium Species threatens more than 2.5 billion people globally and sickens tens of millions annually. Radical cure for P. vivax and P. ovale requires 8-aminoquinoline hypnozoitocidal therapy targeting both the acute blood stage (schizonts) and dormant liver stage (hypnozoites). The only hypnozoitocidal therapies currently available are primaquine and recently approved tafenoquine, both of which can cause acute hemolytic anemia in Glucose-6-phosphate dehydrogenase (G6PD) deficient individuals. Because of valid concerns of drug induced anemia, clinicians are hesitant to, and often do not, prescribe primaquine or tafenoquine due to the high population prevalence (8%), or 400 million individuals, with various levels of inherited G6PD deficiency. The World Health Organization (WHO) currently recommends artemisinin-based combination therapies (ACTs) as a frontline treatment, with higher doses of transmission blocking primaquine and tafenoquine recommended for patients diagnosed with Plasmodium Species, when G6PD status is known. Unfortunately, point-of-care screening for G6PD status is significantly lacking, reducing the frequency that highly effective primaquine and tafenoquine are used for radical cure. The PreQuine Platform will address this unmet need for rapid, cost-effective, simultaneous screening and monitoring of patients for G6PD and Hgb levels. Included within the PreQuine Platform kit are test strips, a meter capable of quantifying G6PD enzyme and Hgb levels, and a built-in cell phone application which allows global tracking using unique patient IDs, monitoring treatment history, and direct connectivity to clinicians able to provide guidance regarding appropriate treatment in real-time. While the ongoing Phase II will successfully finalize the innovative base technology (meter and test strip), there remain several key areas of development required for a successfully commercialized launch, which we can address through the Commercial Readiness Pilot (CRP) Program. More specifically, full commercialization for wide scale adoption of test strips requires additional technical accessories and supporting infrastructure, including optimized meter development and validation, software mobile app development and validation, and system packaging. A full regulatory strategy will require development and execution for both domestic and international markets. Once strategies are established, technical product development will require integration with a fully compliant quality management system to support product launch and post-market surveillance. Commercial launch, market scaling and distribution strategies will be conceptualized and implemented to ensure a full ecosystem exists to transition the company from technical development to self-sustaining commercial sales. Finally, the first article system kits will be produced using all updated technical specifications and quality system controls and deployed in Multicenter Clinical Studies to demonstrate safety and efficacy.