New Agreement Secures Historic US$1 Price for HIV Self-tests

8.1m people in 140 low and middle-income countries to get free access to lifesaving blood test.

MedAccess, the Clinton Health Access Initiative (CHAI), and Wondfo today announced an agreement to make Wondfo’s HIV self-test available for US$1.

The price is over 30 percent below the current lowest-priced World Health Organization (WHO) prequalified test and 50 percent lower than the most widely used test. This makes Wondfo’s HIV self-test the most affordable WHO prequalified self-test on the market.

HIV testing is critical across the ‘cascade of care’ but too often unavailable or inaccessible – as the gateway to treatment and prevention.

An estimated 1 in 5 people living with HIV are undiagnosed, meaning they are not on treatment and are at risk of advanced illness and unknowingly passing on the virus. Testing is the first step in accessing prevention interventions such as pre-exposure prophylaxis (PrEP), for people at high risk of contracting HIV.

The WHO recommends countries implement self-testing as part of a differentiated and comprehensive approach to HIV testing services. Self-tests give countries additional flexibility to meet the needs and preferences of their populations. Increasing access to HIV testing reduces the burden on healthcare workers who must otherwise individually administer each test.

WHO prequalified HIV self-tests have been available since 2017 but the lack of affordably priced products has limited their use, compared to HIV tests conducted by healthcare workers at health facilities in low-income countries.

Under the terms of the volume guarantee provided by MedAccess, Wondfo has committed to launch its newly prequalified HIV self-test at US$1 EXW^[1]for public sector purchasers in 140 low- and middle-income countries. This will allow national HIV programs and key partners to scale up HIV self-testing to further meet growing demand.

Building on the work of governments, Unitaid’s STAR Initiative, PEPFAR, Global Fund, the Bill & Melinda Gates Foundation, and the Children’s Investment Fund Foundation’s (CIFF’s) long-standing support for HIV self-testing, MedAccess projects that improved access to self-testing through this partnership will increase testing and treatment coverage, leading to an estimated 8.1 million additional people accessing testing.

MedAccess also expects HIV self-testing to play an important role in catalysing access to and easing monitoring for critical prevention interventions such as PrEP. 

The benefits of self-testing include:

• Increasing access to HIV testing for priority populations such as men, adolescents, commercial sex workers, people who use drugs, transgender people, and men who have sex with men: globally in 2020, 65 percent of new HIV infections were among people from priority populations and their partners.^[2]People from these groups often face stigma, discrimination, and even criminalisation if they seek an HIV test at a clinic. Self-testing can increase access to HIV testing for these groups. They can be distributed by a range of people including health workers, community leaders, peers, and partners, significantly expanding the channels for reaching people at risk.

• Reducing demands on healthcare workers: distributing HIV self-tests within health facilities can reduce the burden on providers at understaffed clinics. While provider-led testing is and will continue to be a cornerstone of HIV testing, self-tests can significantly increase the efficiency of and access to testing services by reducing the time required per person tested compared to conventional testing. 

• Increasing ease of HIV testing: self-tests are safe, easy to use, and provide accurate results in less than 30 minutes. With expanded HIV self-testing, people will be able to collect HIV self-tests from more and more convenient locations and can then test themselves and read their results in private, when and where they want. This is especially valuable for people at risk of HIV who need more frequent testing as part of HIV prevention programmes. This is timely as WHO releases new guidance on the use of HIV self-testing to support greater access to PrEP services.

Professor Wang Jihua, President of Wondfo said:

“Access to affordable diagnostics, such as HIV self-tests, is essential to closing the testing gap for killer diseases like HIV. We are delighted to enter into this partnership with MedAccess and CHAI to significantly reduce the price of Wondfo’s self-test and increase access in low- and middle-income countries. Our commitment to accelerating access to self-testing underlines our company’s belief in ‘Racing for Life’ – getting the right products to the people who need them as quickly as possible. We are ready to go further with our partners, expanding our efforts towards increasing access to high quality tests at lower costs.”

Dr Dave Ripin, Executive Vice President and Chief Science Officer at CHAI said:

“Significantly expanding use of HIV self-testing is a critical tool for finally closing the treatment gap. Just as importantly, the expansion of testing made possible by this pricing agreement will help generate more demand for key prevention interventions such as PrEP.”

Meg Doherty, Director of WHO Global HIV, Hepatitis and STI Programmes said:

“The announcement of the new pricing is an important step toward making HIV testing for diagnosis and prevention monitoring accessible worldwide. It will help programmes deliver HIV self-tests in public, community, and private sector service delivery channels.”

Dr Geoffrey Taasi, Program Officer HIV Testing and Counselling in the Ministry of Health, Uganda said:

“HIV self-testing is one of the game changers of our time to reach the underserved populations with HIV testing. The convenience to clients and cost-effectiveness for programs are key benefits for scale up. Testing for both case identification and scale up of critical prevention programs such as PrEP require innovations to close the treatment and prevention gaps. In Uganda, the high price of HIV self-test kits has previously been a barrier to expanding HIV self-testing in both public and private sectors despite the country having approved more than two HIV self-test products. The $1 agreement is a super catalyst to our scale up and expansion to reach more people as we look forward to closing the 19% identification gap.”

Michael Anderson, CEO of MedAccess said:

“Self-testing for HIV is crucial for the health of people who are at high risk but face discrimination and criminalisation if they seek a test at a health facility. Our partnership with Wondfo and CHAI will bring a high quality, high-performing test to market at the lowest ever price. We hope this will be a catalyst for other HIV self-test suppliers to lower prices to create a robust market that delivers affordable, high-quality products, increasing choice for users.”