SWITZERLAND—WHO and the Medicines Patent Pool (MPP) have announced a license deal with SD Biosensor Inc., a global in-vitro diagnostic company, to provide a sublicense that grants the partners the right, know-how, and materials to produce SDB’s rapid diagnostic testing (RDT) technology.

This announcement was made in the presence of Dr Yukiko Nakatani, Assistant Director-General for Access to Medicines and Health Products, Hyo-Keun Lee, Vice Chairman of SD Biosensor Inc., and Charles Gore, Executive Director of the Medicines Patent Pool

The COVID-19 Technology Access Pool (C-TAP) negotiated a non-exclusive license agreement that allows for the production of diagnostics for COVID-19 and other diseases like HIV, malaria, and syphilis.

This license will ensure that the technology available under the license is suitable for poor and middle-income nations since it is simple to use, requires no equipment, and has a high sensitivity. 

The license’s broad reach will include COVID-19 diagnostics manufacturing, as well as increasing both its public health value and the predicted benefit to sublicensed manufacturers in terms of broader market prospects and financial sustainability in the inter-pandemic period.

The extensive know-how and support planned for sublicensed manufacturers as part of a phased technology transfer plan is intended to assist LMIC manufacturers in developing their manufacturing capabilities.

This will enable them  to achieve quality production at competitive prices, which can often mean the difference between success and failure.

Furthermore, the increased flexibility of prospective African-based sublicensees to use the license can help grow RDT production in the region and locally.

This follows last year’s announcement by the Global Fund, PEPFAR, and Unitaid to accelerate RDT manufacture on the African continent, initially focused on HIV RDTs, with WHO support.

This agreement, which is in line with the goals of WHA Resolution 76.5, has enabled this technology transfer support.

The goal is to increase diagnostics capacity, which encourages governments to contribute resources to research and product development, as well as to promote diagnostics production capacity locally, particularly in poor countries.

Additionally, it encourages access to diagnostics that assist disease management strategies, which remains a top objective for WHO and its partners.

Dr. Nakatani praised SD Biosensor’s commitment to share its RDT technology through the C-TAP platform, as well as the support it will provide to sublicensees.

The license demonstrates how the C-TAP mechanism can expand beyond COVID-19 to address other public health requirements, as well as WHO’s commitment to technology transfer and advocating the need for increased local manufacturing that benefits all patients, everywhere.

Charles Gore, for his part, stated that this non-exclusive, royalty-free license intends to enhance local and regional output and is fully aligned with MPP’s strategic goals. 

He went on to express his enthusiasm for collaborating with SD Biosensor and new partners, saying that this collaboration extends beyond providing rapid, sensitive diagnostics that are critical for access to treatment but also provides the necessary materials and know-how to do so.

Hyo-Keun Lee, Vice Chairman of SD Biosensor Inc., expressed his pleasure in sharing SD Biosensor’s unique RDT technology with LMIC through the C-TAP platform.

He also stated that in the event of a disease outbreak, rapid response can be achieved using SD Biosensor’s RDT technology on the African continent and that producing these products locally in Africa will improve production efficiency and contribute to improving health value in Africa.

The August 2023 funding announcement underlined the importance of collaboration in accelerating the manufacturing of health products in Africa, with HIV rapid diagnostic tests (RDTs) serving as the initial product emphasis.

In collaboration with WHO, the Global Fund to Fight AIDS, Tuberculosis, and Malaria, the United States President’s Emergency Plan for AIDS Relief, and Unitaid, an open Expert Review Panel for Diagnostic Products is being piloted to solicit Expressions of Interest from African HIV RDT manufacturers to accelerate the availability of quality assured RDTs in Africa.

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