The World Health Organisation (WHO) has endorsed a new diagnostic tool aimed at reducing recurring cases of one of the world’s most persistent forms of malaria.
This tool tests for glucose-6-phosphate dehydrogenase (G6PD) deficiency, a genetic condition affecting over 500 million people globally. G6PD deficiency poses a significant risk when certain malaria treatments are administered, as these medications can trigger acute haemolysis or the destruction of red blood cells.
The Director of WHO’s Global Malaria Programme, Dr Daniel Ngamije Madandi, emphasised the potential of the tool to strengthen malaria responses worldwide by limiting Plasmodium vivax (P. vivax) reinfections and reducing transmission.
“This prequalification can help strengthen the global malaria response by reducing P. vivax reinfections and limiting transmission,” Dr Madandi said.
P. vivax malaria, which affected an estimated 9.2 million people in 2023, remains a global health challenge, present in all WHO regions except Europe.
The G6PD deficiency, while often undiagnosed, can lead to severe side effects when patients with the condition are given certain drugs used to prevent relapses of P. vivax malaria.
The absence of accessible and reliable testing has historically restricted the safe administration of effective anti-relapse therapies.
This new diagnostic tool, developed by SD Biosensor, Inc., addresses this gap by determining G6PD activity levels, enabling clinicians to tailor anti-relapse treatments based on patient-specific enzyme activity levels.
Designed for both laboratory and field use, the device works with a portable hand-held analyser that provides results within minutes. This rapid testing capability is particularly valuable in resource-limited settings where healthcare infrastructure may be insufficient.
WHO Assistant Director-General for Access to Medicines and Health Products, Dr Yukiko Nakatani, stated that the prequalification of this G6PD test would enhance access to quality-assured diagnostics, enabling safer and more effective treatment of relapsing malaria caused by P. vivax.
“The prequalification of this G6PD enzyme test for patients with P. vivax malaria can help countries in enhancing access to much-needed quality-assured tests, enabling safe and effective treatment and prevention of this type of relapsing malaria,” said Dr Nakatani.
The approval follows WHO’s recent update to its malaria treatment guidelines, which now recommend tafenoquine-based regimens in combination with chloroquine to prevent relapses of P. vivax. These updated guidelines offer hope for improved management of this challenging form of malaria.
Despite the milestone, WHO highlighted the need for more diagnostic tools.
Dr Nakatani urged manufacturers to submit additional products for prequalification, emphasising the importance of expanding the range of available diagnostic solutions to meet global demand.
“Currently, no other prequalification applications are received for this type of test. We encourage the submission of additional products to expand the range of effective diagnostic tools available to countries in need,” she added.
