SBIR Phase I: A user-friendly point-of-care device for simultaneous G6PDH and hemoglobin determination

This SBIR Phase I project seeks to transform treatment regimens for individuals suffering from malaria infections. Malaria, particularly caused by Plasmodium vivax (P. vivax) and Plasmodium ovale (P. ovale) remain a potential cause of morbidity and mortality amongst the 2.85 billion people living at risk of infection. The only drug currently available for treatment therapy for P. vivax and P. ovale is primaquine, which can cause life-threatening anemia in individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency. Clinicians often do not prescribe primaquine due to the high prevalence (8%) of individuals who are born with G6PD deficiency. The World Health Organization (WHO) and the Program for Appropriate Technology in Health (PATH) are urgently searching for a reliable assay for the diagnosis of G6PD deficiency to effectively treat patients and aid in the eradication of P. vivax and P. ovale malaria. This novel assay proposed will quantify G6PD and hemoglobin (Hgb) concentration simultaneously from a finger stick sample. This system comprises a single test strip coupled with a reflectance-based meter and cell phone application with Blue Tooth connectivity to incorporate a patient?s I.D., test results, global tracking, and history of treatment. It is projected that this point-of-care assay will be used to screen >23 million people for G6PD within 5 years of launch and generate over $27.5 million in compounded revenue. In the long term, the novel assay will create a universal point-of-care platform that can be utilized for other diseases or conditions that affect patients in the Unites States for which point-of-care assays are not currently available. The proposed novel platform will quantify both Glucose-6-Phosphate Dehydrogenase (G6PD) and hemoglobin (Hgb) concentrations simultaneously from a single finger stick sample using a point-of-care (POC) reflectance-based meter. There is currently no such device on the market, which is urgently needed to screen patients being treated for P. vivax and P. ovale malaria. A significant portion (8%) of the world population is G6PD deficient, which places these individuals at risk for life-threatening anemia after treatment with current therapeutics such as primaquine against malaria. The POC assay utilizes a novel lysis and reagent layer membrane platform to enable a reflectance-based meter to measure non-over lapping wavelengths to quantify G6PD and Hgb concentrations. In this proposal, a functional prototype reflectance-based meter and data collection software will be constructed and compared to readings obtained using the current ?gold standard? Konica Minolta spectrophotometer. Secondly, the POC assay will be validated through performance testing using a G6PD-deficient whole blood specimen bank provided by the Program for Appropriate Technology in Health (PATH). Concordance of the data obtained from 20 samples for the proposed assay will be compared to the World Health Organization?s (WHO) approved spectrophotometric method for measuring G6PD and an FDA approved method for measuring Hgb. Success will be indicated by an R2 > 0.95, which demonstrates linear equivalency, as well as a demonstration that 90% of the data points fall within 2 sigma of each value. A POC assay that can simultaneously screen patients for both G6PD deficiency and Hgb levels will allow clinicians to treat patients with P. vivax and P. ovale malaria infections effectively and aid in the eradication of malaria.