SD Biosensor: G6PD testing
Testing for G6PD enzyme deficiency is essential for healthcare workers to safely provide the most appropriate treatment for P. vivax malaria.
From 2022 to 2025, we provided SD Biosensor with a volume guarantee to secure the availability of G6PD tests in countries with a high P. vivax malaria burden.
The challenge
Public health
The P. vivax malaria parasite caused an estimated 6.9 million cases of malaria in 2022. Complete treatment requires elimination of the parasite from the blood as well as the liver. This treatment is known a ‘radical cure’.
However, doctors are wary of prescribing the most effective treatments because the treatments can cause severe anaemia in patients who are deficient in the enzyme glucose-6 phosphate dehydrogenase (G6PD). This affects 400 million people worldwide.
The World Health Organization (WHO) recommends conducting a G6PD deficiency test prior to treatment of P. vivax malaria patients, to guide treatment decisions. But many countries have not adopted this recommendation meaning point of care G6PD tests are not widely available.
In places with no access to G6PD testing, patients are usually prescribed longer courses of primaquine with lower dosing. However, patients often stop taking the pills when they start to feel better and this can lead to reinfection because the parasite persists in their liver.
Market situation
G6PD testing is required for countries to be able to roll-out tafenoquine, a new, more effective treatment for P. vivax malaria.
However, widespread adoption of G6PD testing has been limited due to inconsistent supply, low affordability, and the absence of cost-effectiveness, operational, and feasibility studies. In turn, commercial sustainability of the product has been threatened by the relatively small market size, uncertain demand, and complexity of producing and commercialising testing equipment. This caused some suppliers to exit the market.
At the time, SD Biosensor’s STANDARD G6PD Test was the only quantitative point-of-care G6PD test on the market. Demand visibility was critical to sustaining production levels and supporting the commercial feasibility of the product, while high-burden priority countries finalised studies, and rolled-out G6PD testing in accordance with WHO recommendations.
Impact
By the end of the agreement:
20,500
additional people on any treatment
42,300
malaria relapses averted
$2m
saved for procurers
The product
The G6PD point-of-care test allows doctors to test patients for G6PD deficiency and receive results within two minutes.
The device requires taking a pin prick of blood, which is tested in the analyzer. This looks for quantitative G6PD enzyme activity.
The analyzer is battery-operated and fits in the palm of one hand, so it can be easily stored and moved.
The partnership
MedAccess provided a volume guarantee to SD Biosensor.
SD Biosensor continued to produce and supply its G6PD testing devices and test strips globally, and offered both products at a reduced price in low-and-middle-income countries.
PATH continued to work with countries with high P. vivax malaria incidence to increase use of G6PD testing and uptake of ‘radical cure’ treatment.
The new ceiling price was available in certain eligible countries.
Impact
Our guarantee helped to ensure the G6PD market remained active ahead of expected market entry by companies with new devices. A healthy market with multiple suppliers will ensure more stable supply of G6PD testing in the future and lead to more competitive pricing.
A more stable G6PD testing market will also support increased prescription of effective treatment, contributing to reductions in P. vivax malaria reinfections and supporting progress towards elimination.
By the end of the agreement, we estimate that the partnership contributed to:
- 20,500 additional people receiving treatment, whereas without testing they wouldn’t have received any medication
- 42,300 fewer P. vivax malaria relapses
- $2 million saved for procurers, over the volume guarantee period.
How we calculated the impact of this agreement
Lives changed
Estimates for treatment eligibility were derived from projections by Watson et al. Estimates of treatment outcomes were derived from a 2020 meta-analysis by Rodrigo et al.
Money saved
Impact was based on actual price reductions for G6PD tests over the course of the volume guarantee.
Markets shaped
We work with partners, including donors, procurers and ministries of health, to track changes in health markets where our investments are supporting access to products. We monitor for changes to policy, procurement practices and supplier movement, all of which affect markets and contribute to the long-term sustainability of impact.