Seattle, WA and Franklin Lakes, NJ, November 10, 2016 — PATH and our partner GSK will collaborate with Becton, Dickinson and Company (BD) to develop a new rapid diagnostic test to support clinical care of malaria patients.
This test aims to support efforts to eliminate Plasmodium vivax malaria, a disease that puts 2.85 billion people at risk worldwide, mainly in Southeast Asia and Latin America. P. vivax is especially difficult to eliminate because the parasite can lie dormant in the liver and cause relapsing illness. Relapse prevention using a class of drugs known as 8-aminoquinolines is the only means to kill the liver form of the parasite. Primaquine, an 8-aminoquinoline that has been available for over 50 years, is recommended by the World Health Organization and typically requires a 14-day regimen. Tafenoquine, an 8-aminoquinoline drug under development by GSK and Medicines for Malaria Venture, is being investigated as a single dose.
8-aminoquinoline drugs can cause serious side effects in patients with severe glucose-6-phosphate dehydrogenase (G6PD) deficiency, a hereditary condition in humans that commonly occurs in places where malaria is found. It is therefore necessary to test patients for G6PD deficiency before administering treatment with an 8-aminoquinoline. However, current diagnostic tests for G6PD deficiency lack simplicity to support scaling up.
“The lack of low-cost, point-of-care diagnostics to test for G6PD deficiency limits access to treatment to relapse-prevention drugs. The end result is patients with P. vivax malaria will continue to suffer from relapsing illness as well as spread the disease,” says Dr. Gonzalo Domingo, Malaria Diagnostics Lead at PATH. “This is a serious challenge to efforts to defeat malaria in countries that are close to eliminating P. vivax.”
To fill this gap, PATH and GSK first entered into an agreement in 2013 to advance a portfolio of new diagnostic tools to detect G6PD deficiency. In order to identify promising candidate tests to advance in development, PATH landscaped the commercial and research marketplace, conducted comparative studies of G6PD assays, developed a target product profile, and evaluated multiple prototypes.
Following this research, PATH and GSK have now partnered with BD, a global medical technology company to develop the diagnostic. In collaboration, BD will develop a point-of-care test for G6PD deficiency that measures levels of G6PD enzyme activity and hemoglobin in a small sample of blood. The test is expected to become commercially available in 2019.
“P. vivax malaria disproportionally affects children, and is known to cause low birth weight and anemia in pregnant women. It is a privilege for BD to be involved in this malaria elimination strategy. BD will bring its competencies and capabilities to develop the new G6PD diagnostics on a point-of-care platform. Simply stated, the collective impact of this collaboration between PATH, GSK, and BD may potentially save human lives,” said Renuka Gadde, BD Vice President for Global Health.
Susan Dixon, GSK Clinical Development Director and Diagnostic Project Leader, said, “Partnering with BD provides a real opportunity to progress the full development and registration of a new G6PD diagnostic. This will be hugely important in ensuring that patients can safely access 8-aminoquinolines such as tafenoquine, if approved for use, to prevent malaria relapse.”
Funding to PATH to support advancement of new G6PD diagnostic tools has been provided by the Bill & Melinda Gates Foundation and the United Kingdom Department for International Development.
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. Learn more at www.path.org.
BD is a global medical technology company that is advancing the world of health by improving medical discovery, diagnostics, and the delivery of care. BD leads in patient and health care worker safety and the technologies that enable medical research and clinical laboratories. The company provides innovative solutions that help advance medical research and genomics, enhance the diagnosis of infectious disease and cancer, improve medication management, promote infection prevention, equip surgical and interventional procedures, and support the management of diabetes. The company partners with organizations around the world to address some of the most challenging global health issues. BD has more than 40,000 associates across 50 countries who work in close collaboration with customers and partners to help enhance outcomes, lower health care delivery costs, increase efficiencies, improve health care safety, and expand access to health. For more information on BD, please visit www.bd.com.