Approximately half of the world’s population is at risk of malaria, a life-threatening disease caused by parasites transmitted by mosquitoes. In 2010, 99 countries had ongoing malaria transmission, with an estimated 655,000 deaths, mostly in African children under the age of 15. Malaria is preventable and curable, and early diagnosis and treatment of malaria prevents deaths and reduces transmission.
The World Health Organization recommends that all cases of suspected malaria be confirmed using parasite-based diagnostic testing before administering treatment. Reliable, robust, and cost-efficient microscopy and rapid diagnostic test technologies are necessary to eradicate malaria in the poorest regions of the world, where it is most devastating.
The majority of the malaria disease burden is caused by two sub-species of the Plasmodium parasite. Plasmodium falciparum is the most aggressive sub-species and is responsible for the highest mortality, primarily in Africa. Plasmodium vivax (P. vivax) is less aggressive but more difficult to clear from a patient. P. vivax primarily impacts Asia and the Americas. Because of the wide diversity in geographical context, health systems, and disease epidemiology, multiple diagnostic tools are required to support control and elimination initiatives. PATH is responding to these diverse needs at multiple levels.
Areas of focus
Improving global access to standard diagnostic tests
In some countries with high malarial burden, predominantly in Africa, access to available diagnostics and drugs is limited. In response to the urgent need for universal access to diagnostic testing, the Malaria Control Partnership at PATH is supporting national programs to implement systems that will ensure health care providers that manage symptomatic patients have access to rapid diagnostic tests and microscopy to inform febrile case management. Universal access to diagnostic tests is critical to managing patient care; those who test positive will receive antimalarials, while patients who test negative can be treated more promptly for other causes of febrile disease.
Supporting malaria elimination through disease surveillance
As the prevalence of malaria decreases, there is a need for tests that can detect lower levels of parasites in patients or detect past exposure to malarial infection. PATH is articulating these needs in the form of use-case scenarios and target product profiles in order to guide industry product development of diagnostic tests to support elimination efforts. The Diagnostic Group at PATH is working to incentivize the private sector to develop tests that meet these requirements.
Supporting radical cure for P. vivax
A key bottleneck to achieving elimination is the effective treatment of malaria caused by P. vivax infection. There is currently only one class of drugs, 8-aminoquinolines, which can entirely clear the parasite from a patient (radical cure). Unfortunately, patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency, are at high risk of experiencing adverse events such as acute hemolytic anemia if prescribed this class of drugs. G6PD deficiency is a common human genetic trait that is particularly prevalent in regions typically endemic for malaria. There is an urgent need for point-of-care G6PD tests to promote safe access to these drugs and the best case management of patients with P. vivax infection. PATH is working with national malaria programs, manufacturers, and other key stakeholders to accelerate development and introduction of point-of-care G6PD tests where they are most needed.