HEMEX HEALTH INC — Department of Health and Human Services SBIR Phase II: NIAID

Description

Project Summary/Abstract While significant progress has been made in reducing malaria prevalence and deaths, malaria elimination remains an extremely difficult goal. P. falciparum and P. vivax species of malaria parasites account for ~95% of all human malaria infections. P. falciparum is more virulent and has a higher incidence of adverse clinical outcomes, but P. vivax is more pervasive and widespread, often becoming the predominant species in regions moving toward elimination. These parasites follow a different course of disease and the treatment regimen differs, requiring an additional drug for P. vivax to eliminate a liver stage which causes disease relapse potentially years after infection. Current diagnostics have suboptimal accuracy, especially for P. vivax, as well as delayed turnaround times. Hemex aims to develop a one-minute, $1, point-of-care diagnostic that has a limit of detection for P. vivax andgt;5x lower than RDTs. This diagnostic platform will also have the ability to differentiate between P. falciparum and P. vivax to allow for appropriate treatment. The proposed project advances our current rapid malaria detection device, which detects the presence of any malaria parasites in patients with andgt;95% accuracy compared to microscopy. The new capability will be commercialized into a robust, portable, point-of-care product. It has the potential to greatly reduce malaria transmission and could substantially contribute towards reduction in human suffering as well as help to achieve malaria elimination.Project Narrative Plasmodium vivax remains one of the primary challenges of elimination efforts. Determining if an infection is P. vivax is important since the progression of the disease and subsequent drug regimen differs from the other main form of malaria, P. falciparum. This project proposes to enhance and expand our current highly sensitive point-of-care diagnostic, which currently detects malaria from all species down to less than 50? parasites per microliter, to also differentiate the parasite species in order for the appropriate treatment to be delivered. The proposed new device will take advantage of the different sizes and distribution of the iron-containing hemoglobin digestive by-product, called hemozoin, which is smaller and more diffuse in P. vivax than in P. falciparum.