P. vivax malaria is common in Asia, Latin America, and the horn of Africa, and the World Health Organization (WHO) estimates two and a half billion people worldwide are at risk of infection. It is also known as relapsing malaria, causing recurring bouts of illness unless a patient receives treatment to kill parasites in the liver, known as radical cure. Without radical cure, the cycle of P. vivax transmission can continue in a community, which threatens efforts to completely eliminate the disease. However, patients with a condition known as glucose-6-phosphate-dehydrogenase (G6PD) deficiency can become seriously ill if given radical cure with an 8-aminoquinoline-based drug.
WHO recommends that patients be tested for G6PD deficiency before radical cure is administered. Currently available rapid tests for G6PD deficiency do not adequately determine the G6PD status of women who carry the gene for G6PD deficiency on only one X chromosome and have intermediate G6PD activity levels. Current tests that provide this level of determination of G6PD activity in women are too expensive and complex for use at the point of care in low-resource settings where P. vivax is endemic.
To address this gap, PATH is advancing a portfolio of novel rapid tests for G6PD deficiency that are low cost, simple to use, and meet specifications to improve treatment of patients with P. vivax malaria and support elimination programs. As part of this work, PATH partnered with SD Biosensor to develop and evaluate a new diagnostic for G6PD deficiency.
SD Biosensor's STANDARD G6PD Test is a handheld device that delivers results in two minutes and provides a quantitative measure of G6PD activity, including in heterozygous women. The test uses a small sample of blood, which is placed on a disposable strip and inserted into the reusable device, a format similar to a blood glucose meter that is easy to use at the point of care in low-resource settings. It provides a quantitative measurement of both G6PD levels and total hemoglobin, enabling health workers to determine if radical cure with an 8-aminoquinoline-based drug is appropriate for patients.
"The STANDARD test fills a critical need by improving the ability for health care providers to determine the G6PD status of a patient when it is most needed," says Dr. Gonzalo Domingo, scientific director and malaria diagnostics lead at PATH. "The strength of the partnership resides in SD Biosensor's commitment to making the test available and affordable for malaria-endemic settings."
SD Biosensor has CE marked the STANDARD G6PD Test to conform with the European Union IVD Directive (98/79/EC) and the test is currently undergoing further clinical evaluations. Full clinical evaluation of the test through studies in Brazil, Ethiopia, and India is expected by mid-2019.
PATH will support and guide SD Biosensor in the registration, manufacture, and sale of the new test in countries where P. vivax is endemic and this product will be most impactful. PATH will work with SD Biosensor to provide the STANDARD G6PD Test at favorable pricing terms to priority countries, ensuring that cost will not pose a significant barrier to access where the test is needed most.
Funding to PATH to support advancement of new G6PD diagnostic tools has been provided by UKAid from the United Kingdom department for international development and the bill & melinda gates foundation.
PATH is the leader in global health innovation. An international nonprofit organization, PATH saves lives and improves health, especially among women and children. PATH accelerates innovation across five platforms—vaccines, drugs, diagnostics, devices, and system and service innovations—that harness our entrepreneurial insight, scientific and public health expertise, and passion for health equity. By mobilizing partners around the world, PATH takes innovation to scale, working alongside countries primarily in Africa and Asia to tackle their greatest health needs. With these key partners, PATH delivers measurable results that disrupt the cycle of poor health.
SD Biosensor is an in vitro diagnostics company with the goal of contributing to improving the quality of life through fast and accurate diagnosis of disease. Since our foundation, we have provided blood glucose monitors, glycated hemoglobin analyzers, cholesterol analyzers, ELISA kits, and rapid test kits worldwide. As a global diagnostics company, we have set a new benchmark for in vitro diagnostics with our core technologies. At SD Biosensor, we provide diagnostic products of excellent quality by developing fluorescence immunoassay products that can perform qualitative as well as quantitative results using antigen and antibody responses.