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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 5.4 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 as of end-2025:

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.

SD Biosensor's G6PD analyzer

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.

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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 at the end of 2025, 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.

Wondfo: HIV self-test

Self-testing enables people at risk of HIV to test themselves quickly, conveniently and discreetly.

Since 2022, we have supported Wondfo with a volume guarantee to offer its HIV self-test at a record low price, helping national HIV programmes expand use among key populations.

The challenge

Public health

HIV causes AIDS, which is one of the leading causes of death by infectious disease. In 2022, more than 5 million people living with HIV did not know their HIV status, meaning they are not on treatment and are at risk of developing AIDS-related illnesses and unknowingly passing the virus on. Testing is the gateway to accessing HIV prevention, treatment, and care.

Current HIV testing strategies are not effectively reaching priority populations, such as people who use drugs, sex workers and LGBTI people. People from these groups often face stigma, discrimination, and even criminalisation if they seek an HIV test at a clinic. The World Health Organization (WHO) recommends countries implement self-testing as part of HIV testing services.

Market situation

WHO prequalified HIV self-tests have been available since 2016. They are not widely used in lower-income countries because of their historically higher costs compared to professional-use tests offered in health facilities.

Global health organisations have provided a lot of support to introduce and scale-up HIV self-testing, with six suppliers now providing WHO-prequalified tests. However, the market remains dominated by a single company, leading to higher prices and limited use as donors and countries face pressure on HIV budgets.

Impact

By the end of 2025:

An additional

1.23m

people tested for HIV

An additional

19,800

people living with HIV starting treatment

$1.12m

in savings for procurers

The product

HIV self-tests are safe, easy to use, and provide accurate results in less than 30 minutes.

People will be able to collect self-tests from convenient locations before testing themselves and reading their results in private, when and where they want. This is especially valuable for people at higher risk of HIV who need more frequent testing.

The test requires taking a pinprick blood sample which is tested in the device. If a person returns a positive test, they should seek a confirmatory test with a qualified health worker.

Wondfo's HIV self-test

The partnership

MedAccess provided a volume guarantee to Wondfo.

Wondfo committed to launch its newly prequalified HIV self-test at $1 for public sector purchasers in 140 low- and middle-income countries. This will enable national HIV programmes and key partners to scale up HIV self-testing to meet growing demand, enable the expansion to new use-cases for self-testing (e.g. for pre-exposure prophylaxis (PrEP) monitoring) and increase treatment coverage.

CHAI helped facilitate the volume guarantee and supports countries’ adoption of the prequalified HIV self-tests.

Impact projections

Wondfo’s HIV self-test obtained WHO prequalification in July 2022 and national registrations in priority countries are ongoing, helping to build long-term supply security.

Our guarantee enabled Wondfo to reduce the price of its self-test to the lowest on the market, driving competition and setting a benchmark price for future entrants. This brings the price close to that of professional-use tests, giving countries a wider range of options to choose from and the flexibility to design programmes that take advantage of the unique benefits of HIV self-tests.

It also improves the attractiveness of HIV self-tests as an option for expanded use cases where frequent testing is recommended, such as supporting the use of pre-exposure prophylaxis (PrEP).

We project that improved access to self-testing through this partnership will contribute to:

  • 8.1 million additional people tested for HIV and an additional 131,000 people starting treatment.
  • 33% reduction in HIV self-test price for public procurers.

How we calculate the impact of this agreement

Lives changed

Estimates for test uptake and linkage to care are based on a meta-analysis by Njau et al. Average HIV positivity rates for Africa reported by UNAIDS were applied to estimate people living with HIV identified through testing.

Money saved

Impact is based on comparing the negotiated price to the expected lowest priced equivalent HIV self-test.

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.

SD Biosensor: Dual test for HIV and syphilis

Syphilis testing rates in pregnant women lag far behind those for HIV, despite the serious risks to mothers and babies.

From 2021 to 2025, we supported SD Biosensor with a volume guarantee to reduce the price of its HIV/syphilis rapid test, enabling more countries to protect mothers and babies with dual testing.

Impact

By the end of the agreement:

770k

pregnant women with syphilis treated

162k

stillbirths averted

$13.6m

saved for procurers

The product

The dual test is a point-of-care rapid diagnostic test that simultaneously detects antibodies to both Treponemal pallidum (TP, the cause of syphilis infection) and HIV in under 20 minutes from a single finger-prick blood sample.

The dual test means syphilis testing can be integrated into HIV testing programmes in antenatal care settings, closing the testing gap between HIV and syphilis.

SD Biosensor's dual test

The partnership

MedAccess provided a volume guarantee to SD Biosensor for the dual test.

SD Biosensor agreed to reduce the price of its dual test to below $1 for public purchasers in over 100 low- and middle-income countries. SD Biosensor continued to produce and supply the dual test, increasing availability and access to the product in low-and-middle-income countries.

CHAI helped to facilitate the volume guarantee agreement and continues to support country adoption of the dual test.

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How we calculated the impact of this agreement

Lives changed

Estimates for additional women receiving access to syphilis testing were based on 2020 antenatal testing coverage for syphilis in African countries. Downstream patient outcomes were estimated based on 2020 seroprevalence and treatment rates in African countries, and a meta-analysis of risk for adverse outcomes of pregnancy by Gomez et. al.

Money saved

Impact was based on comparing the negotiated price to the expected weighted average market price of HIV-syphilis dual tests, including expected distributor mark-up where relevant.

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.

Hologic: Viral load testing

Millions of people living with HIV cannot access the regular viral load testing needed to keep their treatment on track and prevent onward transmission.

From 2018 to 2022, we provided a volume guarantee to Hologic which enabled the company to set an all-inclusive ceiling price of $12 per test on its Panther® platform, increasing access to viral load testing for millions of people.

Read case study

The challenge

Public health

HIV causes AIDS, which is one of the leading causes of death by infectious disease. HIV transmission can be reduced if patients start taking combinations of medicines – called antiretroviral therapy (ART) – soon after acquiring HIV. Effective ART regimens can suppress HIV viral load, which can prevent death and onward transmission and allow patients to live longer, healthier lives.

In 2014, UNAIDS launched the “90-90-90” targets, calling for 90% of people living with HIV to know their status, 90% of those diagnosed to receive treatment, and 90% of those on treatment to achieve viral suppression by 2020. Those targets were later updated to “95-95-95” by 2030. However, in 2017, the year before the MedAccess agreement, only 81% of people receiving antiretroviral therapy were virally suppressed, and millions of people with HIV lacked access to viral load testing.

Market situation

Hologic’s Panther® platform can test for HIV and viral hepatitis viral load and provide diagnosis for COVID-19 and human papillomavirus (HPV), the leading cause of cervical cancer. The Panther® platform obtained World Health Organization (WHO) pre-qualification in December 2017.

The total size of the viral load market was around $190 million a year. At the time, the two dominant suppliers in Africa offered HIV viral load testing at a wide range of prices. Procurement of products and services was fragmented, leading to untransparent pricing. As a result, access to regular viral load testing was often limited in sub-Saharan Africa. Countries that had purchased viral load testing equipment had many machines out of use due to inconsistent service and maintenance.

Impact by end-2022

By the end of the agreement:

932k

patients not virally suppressed identified

457k

patients switched to 2nd-line treatment

The product

Hologic’s Panther® platform provides fully automated molecular testing for HIV, viral hepatitis, human papillomavirus and COVID-19. Its sample-to-result automation can run 320 tests in 8 hours, providing health care professionals and patients with faster access to accurate viral load or diagnostic results to support treatment decisions.

The Panther® platform can test for a range of illnesses simultaneously. In countries with high rates of coinfections alongside HIV, it can reduce the time patients wait for test results and lead to improved care.

Hologic's Panther platform

The partnership

MedAccess provided a volume guarantee to Hologic, agreeing to make up any shortfall in the agreed sales volumes.

Hologic agreed to register Panther® for use in 50 low- and middle-income countries, and set a multi-country, all-inclusive ceiling price of $12 per patient test (a 30% price reduction on all products and services required to generate an HIV viral load test result), including the cost of placing the instrument, consumables and reagents, staff training and instrument service and maintenance. This was the first time a company had offered an all-inclusive price for viral load testing.

The Clinton Health Access Initiative (CHAI) supported the formation of the partnership and is responsible for monitoring the implementation of the agreement.

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Impact by end-2022

By the end of the agreement:

13

countries switched to all-inclusive tender process

$45m

direct savings for procurers

13

countries now have more than two suppliers of viral load testing

The impact

By the end of the agreement in 2022, our guarantee had helped bring a new level of consistency and transparency, improved platform maintenance, and a new approach to procurement by funders. This has helped to stimulate price reductions up to 50% in some countries.

The introduction of the all-inclusive pricing framework improved procurement practices in the wider market, allowing for improved price transparency for HIV viral load procurement.

Supply security also improved with Hologic registering Panther® in 13 new countries where there were previously limited competitors.

The partnership has resulted in 932,000 patients benefitting from improved clinical outcomes and $45 million savings by purchasers.

Read case study

How we calculated the impact of this agreement

Lives changed

Impact was based on estimates of the total reach of guaranteed tests and the depth of impact on patients by those tests. The depth factor was derived from the proportion of people receiving a viral load test that will switch to second-line antiretroviral therapy and the HIV-related mortality and disability burdens in Africa.

Money saved

Impact was estimated based on actual price reductions achieved throughout 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 our investments. To quantify change against a baseline, we used publicly available indicators as proxies for market-wide change.

Hemex: Sickle cell disease diagnosis

Sickle cell disease (SCD) is the most common genetic disease in the world. Every year, more than half a million babies are born with the disease. Without early diagnosis and access to basic care, mortality remains extremely high.

In 2025, we partnered with Hemex to provide a working capital facility (loan) to help the company scale up access to its Gazelle® SCD testing platform.

The challenge

Public health

SCD is a genetic condition that affects red blood cells, causing them to become stiff and crescent-shaped. These misshapen cells can block blood vessels, leading to pain, organ damage, and serious complications like anaemia, strokes and infections.

Without proper care, children with SCD face high risks – especially in low-resource settings. Around 500,000 babies are born with SCD each year, mostly in Sub-Saharan Africa and India. In 2021, sickle cell disease caused more than 81,000 deaths among children under five, making it the 12th leading cause of death in this age group worldwide. The true toll is likely even higher, as many children die before ever receiving a diagnosis.

Early diagnosis through newborn screening can save lives by enabling timely treatment – such as antibiotics, malaria prevention and vaccinations – and non-medical interventions. Despite its global impact, access to screening and care remains limited in many countries, making SCD a major public health concern recognised by the UN and WHO.

Market situation

In high-resource countries, newborn screening and proper care have greatly improved life expectancy for people with SCD. But in low-resource settings, scaling up testing and treatment is difficult, meaning millions of children are not tested and therefore those with SCD do not start treatment early.

Standard tests used in many countries rely on expensive equipment and skilled staff, which many low-resource areas cannot afford or support.

Near point-of-care (POC) testing, which takes place where the patient would be treated rather than in a laboratory, offers a more practical alternative, especially in remote regions. Hemex’s Gazelle® device is portable, accurate, and designed for use in these settings, helping make early diagnosis and care more accessible and affordable.

The product

The product

The Gazelle® diagnostic platform, launched in 2021, is a major innovation in sickle cell testing. It offers highly accurate, lab-quality results in minutes, using a simple, portable device that does not require expert training. 

It uses a small reader and disposable cartridges to analyse blood samples, delivering results in just eight minutes.

Gazelle® is accurate and easy to use in low-resource settings, and can also test for other conditions like malaria, hepatitis, and COVID-19. Clinical studies show it performs as well as standard lab tests.

 

 

The partnership

MedAccess has provided a $2.5 million working capital facility to Hemex.

Hemex will work to scale up access to its Gazelle® platform in India, the Middle East and sub-Saharan Africa.

Impact projections

SCD is a neglected area with limited global funding to support screening and early intervention. Hemex’s SCD test provides a near POC testing option that is easy to use and accurate.

The working capital facility will contribute to increased access to SCD testing through support for continued Hemex growth in India and across sub-Saharan Africa.

Lives changed

MedAccess projects that an additional six million people will be reached with SCD testing on the Gazelle® platform during the working capital facility’s three-year tenor.

Markets shaped

The working capital facility is expected to have significant market shaping impact on the sickle cell diagnostic market, and potentially impact the wider health system through increasing access to novel low-cost, accurate blood tests:

  • Accelerate scale-up
  • Encourage innovation and investment
  • Build competition.

How we calculate the impact of this agreement

Lives changed

People reached estimates are based on the public health context and expected usage rates of the Hemex Gazelle® platform.

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. 

 

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