New partnership to increase access to dual rapid testing for syphilis and HIV

MedAccess, CHAI and SD Biosensor announce partnership to make dual rapid test for syphilis and HIV available for under US$1 in over 100 low- and middle-income countries.

MedAccess, the Clinton Health Access Initiative (CHAI) and SD Biosensor today announced a partnership to significantly increase access to innovative combined rapid testing for syphilis and HIV. SD Biosensor’s STANDARD Q HIV/Syphilis Combo test will now be the first World Health Organization (WHO) prequalified combination HIV/syphilis test available for under $1 for public sector purchasers in low- and middle-income countries.

The point-of-care rapid diagnostic test enables simultaneous diagnosis of both syphilis and HIV in under 20 minutes from a single finger-prick sample. Pregnant women with a confirmed diagnosis can start treatment more quickly, protecting both their health and their unborn child. Each year, more than 210,000 stillbirths or newborn deaths are caused by congenital syphilis, which could be prevented if the mother is tested and treated in time.

The partnership, made possible by a volume guarantee agreement between MedAccess and SD Biosensor, enables the South Korean diagnostics company to offer a price reduction of over 32 percent, making STANDARD Q the lowest priced WHO prequalified dual HIV/syphilis test on the market. This new price can contribute to bridging the gap of more than 6 million pregnant women in the highest burden countries who know their HIV status but are currently not tested for syphilis.[1]

Ms. Joy Phumaphi, interim co-CEO of CHAI stated:

“Every year hundreds of thousands of syphilis infections pass undiagnosed from mothers to their unborn children, resulting in stillbirths, congenital defects, or deaths of their newborns. In many cases they never even know the cause. This agreement has the potential to revolutionise syphilis testing in low- and middle-income countries, ensuring mothers are tested during their pregnancy and provided with affordable and readily available treatment to cure the disease and prevent transmission.”

Michael Anderson, MedAccess CEO, added:

“Syphilis brings devastation to thousands of women and their families, turning what should be a time of joy into one of deep despair. Through this partnership, SD Biosensor is leading the way on increasing access to innovative dual testing, helping to protect women and children from the lifechanging effects of both HIV and syphilis. This is the clearest possible example of how innovative finance can reduce costs and increase access to essential diagnostics, which remains a critical healthcare gap, with almost half of the global population still having little to no access to quality diagnostics.”[2]

Tae Young Heo (Taylor), Chief Executive Officer of SD Biosensor, said:

“We are very pleased to offer the HIV/syphilis rapid dual test at an affordable price to many low- and middle-income countries through this partnership. Syphilis remains the second leading cause of stillbirths worldwide. We hope that the STANDARD Q test will provide rapid diagnosis for many pregnant women suffering from the disease, enabling them to be treated as soon as possible.”

While screening for HIV is routine in many countries during antenatal care, antenatal syphilis screening and treatment rates remain low across sub-Saharan Africa and parts of Asia. In many countries, up to 95 per cent of women are tested for HIV during antenatal care,^[i] but less than 50 per cent are tested for syphilis.^[ii] Despite the WHO’s 2019 recommendation for rapid dual testing of HIV and syphilis for pregnant women during antenatal care,^[iii] only 23 per cent of countries have adopted the test in their antenatal care programs.^[iv]

The test’s new reduced price – $.95 ex works for public sector orders placed directly with the manufacturer – is an opportunity to catalyse the introduction of dual HIV/syphilis tests into existing antenatal care platforms to close the testing gap between HIV and syphilis, increasing rates of maternal syphilis diagnosis and linkage to treatment.^[v] For instance, introducing the dual HIV/syphilis test in place of a single HIV test in Nigeria would more than double syphilis screening rates.^[vi]

The countries included in the agreement account for 98 percent of the global burden of congenital syphilis and 93 per cent of the global HIV burden. Despite maternal syphilis being readily treatable through a form of penicillin that is off patent, widely supplied, and typically available at US$0.50 per dose in low- and middle-income countries,^[vii] this devastating sexually transmitted infection leads to an estimated 355,000 adverse pregnancy outcomes annually.^[viii]

“The announcement of the new dual HIV/syphilis test pricing is exciting,” said Meg Doherty, Director of WHO Global HIV, Hepatitis and STI Programmes. “It will help more countries adopt the dual HIV/syphilis testing and accelerate progress toward EMTCT for both HIV and syphilis and deliver services for key populations, where both HIV and syphilis infections are common.”

Syphilis remains the second leading cause of stillbirths globally and is attributed to 11 percent of all stillbirths occurring each year across Africa. Combining effective treatment delivery with increased syphilis screening rates that match those for HIV among pregnant women in the 20 highest burden countries could eliminate one-third of the adverse outcomes resulting from syphilis infection —saving at least 74,000 lives and averting 53,000 cases of severe illness each year.  It will significantly contribute to the WHO’s goal of eliminating mother-to-child transmission of HIV, syphilis, and hepatitis B.  The benefits of increased syphilis testing in pregnant women will extend beyond the health of the child, to also ensure that women and their partners are diagnosed and treated.

MedAccess is a social finance company, wholly owned by the UK’s CDC Group. Its work on this partnership was funded by UK aid through the Foreign, Commonwealth & Development Office.

About

The Clinton Health Access Initiative, Inc. (CHAI) is a global health organization committed to saving lives and reducing the burden of disease in low- and middle-income countries, while strengthening the capabilities of governments and the private sector in those countries to create and sustain high-quality health systems that can succeed without our assistance. For more information, please visit: http://www.clintonhealthaccess.org

MedAccess’ mission is to make global healthcare markets work for everyone. Its core purpose is to make medical supplies more widely available at lower prices in under-served markets. By applying the rigour and skills of business finance, MedAccess provides a novel solution to the challenge. MedAccess offers volume guarantees 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. MedAccess is a UK-based social finance company wholly owned by the UK’s CDC Group. Its work is funded by UK aid through the Foreign, Commonwealth & Development Office. For more information see https://www.medaccess.org and follow MedAccess on Twitter @MedAccessUK.

SD Biosensor is a company specialising in point-of-care testing. It is a total solution provider in the in-vitro diagnostics (IVD) industry, meaning not only does it sell on-site diagnostic reagents and equipment that diagnoses diseases with simple methods in the field, but also takes the responsibility for developing and manufacturing them. SD Biosensor has established a full line-up portfolio, extending from screen tests to confirmation tests, which account for about 70% of the global IVD market. Since the outbreak of COVID-19 last year, the company has developed more than 20 COVID-19 reagent-kits, of which the COVID-19 Ag Test was the first in the world to obtain WHO Emergency Use Listing. Moreover, SD Biosensor has been successfully selling M10, the on-site molecular diagnostic platform, after its launch in August. For further information, please refer to the official website: https://www.sdbiosensor.com

References

[1] Based on the 10 LMICs (excluding India) with the highest number of pregnancies with active syphilis (Indonesia, Democratic Republic of Congo, Mozambique, Uganda, Nigeria, Mal, Tanzania, Angola, Ethiopia, and Madagascar).

[2] https://www.thelancet.com/action/showPdf?pii=S0140-6736%2821%2900673-5

[i] UNAIDS. HIV testing among pregnant women. Joint United Nations Programme on HIV/AIDS. 2017. http://aidsinfo.unaids.org/?did=5b55166567e422581636f6ed&r=world&t=null&tb=d&bt=dnli&ts=0,0&tr=world&tl=2 (accessed May 7, 2019).

[ii] WHO. Report on global sexually transmitted infection surveillance 2018. World Health Organization. 2019. https://www.who.int/reproductivehealth/publications/stis-surveillance-2018/en/ (accessed May 7, 2019).

[iii] WHO, Dual HIV/syphilis rapid diagnostic tests can be used as the first test in antenatal care. 2019. https://www.who.int/publications/i/item/WHO-CDS-HIV-19.38

[iv] Global AIDS Monitoring (UNAIDS/WHO/UNICEF) and Global HIV, Hepatitis and STIs Programmes (HSS), WHO, 2021

[v] https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(19)30248-7/fulltext

[vi] https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(19)30248-7/fulltext

[vii] https://supply.unicef.org/s1559005.html

[viii] https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(19)30248-7/fulltext