P. vivax malaria elimination efforts boosted by new agreement to expand access to G6PD testing

P. vivax causes an estimated 6.4 million cases of malaria per annum[1]. Eradication of P. vivax malaria remains challenging, as the parasite often persists in the patient’s liver following treatment of the infection in the bloodstream, causing reinfection and relapse.

For complete treatment of P. vivax malaria, known as ‘radical cure’, the World Health Organization (WHO) recommends chloroquine or artemisinin combination therapy followed by a course of 8-aminoquinoline drugs – primaquine or tafenoquine – to treat liver-stage infection. However, 8-aminoquinoline drugs can trigger a severe blood disorder known as haemolytic anaemia in patients who are deficient in the enzyme glucose-6 phosphate dehydrogenase (G6PD), a condition that affects over 400 million people worldwide.

To avoid administering 8-aminoquinoline drugs incorrectly to G6PD deficient patients, the WHO recommends conducting a G6PD deficiency test prior to treatment. This is especially critical for tafenoquine, as it is a single dose treatment and remains in the blood for several days after intake.

However, this recommendation has not been adopted in many countries, as point-of-care G6PD tests are not widely available. As a result, doctors are often cautious, prescribing lower doses of 8-aminoquinoline drugs taken over longer periods. This can lead to patients stopping treatment when they feel better, despite the infection not being cleared.

The SD Biosensor STANDARD G6PD Test is currently the only quantitative point-of-care G6PD test on the market. MedAccess has provided a volume guarantee to secure supply of G6PD testing and enable SD Biosensor to reduce the price of its point-of-care G6PD devices and testing strips in low- and middle-income countries. PATH will continue to work with countries with P. vivax malaria incidence to introduce and increase access to G6PD testing and uptake of radical cure treatment.

“We have an opportunity to substantially reduce the sickness and death that P. vivax malaria inflicts on communities every year while contributing towards eliminating the disease,” said Michael Anderson, CEO of MedAccess. “Our partnership with SD Biosensor and PATH will not only unlock access to G6PD testing but also to highly effective treatment options that will cure people more quickly and reduce reinfections. This is a good example of how smart finance can support business in global health to unlock benefits for patients.”

“This test fills a critical market need by improving the ability for healthcare providers to determine the G6PD status of a patient when it is most needed,” said Dr. Gonzalo Domingo, scientific director and malaria diagnostics lead at PATH. “This volume guarantee will ensure that the test continues to be available in malaria-endemic settings.”

A SD Biosensor, Inc. representative stated “STANDARD G6PD Test will be distributed not only in Africa but also, in low- and middle-income countries where G6PD diagnosis is required. Through this partnership, we are very glad to provide our STANDARD G6PD Test to low- and middle-income countries at an affordable price and to collaborate with international organisations for the purpose of eliminating P. vivax malaria through social collaboration.”

MedAccess’ guarantee is a crucial market-shaping intervention for G6PD testing and for P. vivax malaria treatments more broadly. Multiple countries are currently in the process of introducing and piloting treatment courses that are expected to increase adherence and reduce patient relapse, such as short course primaquine treatment and tafenoquine. Maintaining supply of G6PD testing is critical for the continuation of these programs.

SD Biosensor and PATH began working together in 2018 to develop a point-of-care G6PD diagnostic to be available in key markets and support the elimination of P. vivax malaria. The product, which was developed with support from the Bill & Melinda Gates Foundation and the UK’s Foreign, Commonwealth & Development Office, received approval from the Australian Therapeutic Goods Administration in May 2021.

Ends

For further information, please contact Rob Kelly, Head of External Relations at MedAccess,
on +44 7867 132038 or rkelly@medaccess.org

Have more questions? See the FAQ page: https://www.path.org/programs/diagnostics/medaccess-volume-guarantee-for-sd-biosensor-standard-g6pd-test/

About MedAccess

MedAccess is a UK-based social finance company with a mission to make global healthcare markets work for everyone. By applying the rigour and skills of business finance, it provides a novel solution to the challenge. MedAccess offers financial guarantees and debt products that reduce commercial risk and allow medical manufacturers to accelerate supplies into new markets at affordable and sustainable prices. In this way, vaccines, medicines, diagnostic tests and medical devices can reach patients far sooner than existing market forces would allow.

For more information see www.medaccess.org and follow MedAccess on Twitter @MedAccessUK

About SD Biosensor

SD BIOSENSOR is a company specializing in IVD product development and manufacturing with the goal of contributing to improve the quality of life through fast and accurate diagnosis of disease. Since the foundation, SD BIOSENSOR has provided various diagnostic solutions such as blood glucose monitoring system, dry chemistry analyzers, ELISA, rapid test kits, fluorescent test system and molecular test system worldwide. From 2020, the company is supplying numerous diagnostic products that are WHO prequalified for the global public health, especially for malaria, HIV, HCV, and COVID-19. To learn more about SD BIOSENSOR’s products, please visit http://en.sdbiosensor.com/xe/

[1] https://www.who.int/publications/i/item/9789240015791