FIND, the global alliance for diagnostics, has announced a support package that includes a total investment of $7 million alongside technical assistance and clinical evaluations to accelerate the availability of affordable SARS-CoV-2 self-tests in low- and middle-income countries (LMICs).
Following an open call for partners and a competitive selection process, contracts with the following companies have now been finalised: ACON Biotech (Hangzhou) Co. Ltd (China), Osang Healthcare (Republic of Korea), Jiangsu BioPerfectus Technologies Co. Ltd (China) and Premier Medical Corporation (India).
The request for proposals (RFP) process was launched by FIND in March 2021, in the context of the Access to COVID-19 Tools (ACT) Accelerator diagnostics pillar, which FIND co-leads. The diagnostics goals of the ACT-Accelerator Strategy and Budget include strengthening capacity for countries to expand access to COVID-19 testing, based on strategies to reach people where they live, work, and seek care, such as decentralised community-based testing and self-testing.
This RFP was launched in response to overburdened healthcare systems in LMICs, and the realisation that an urgent step change in the use of diagnostics was needed to narrow the global equity gap. Reducing this gap requires strengthening existing testing models and expanding genomic sequencing efforts, while also implementing new, decentralised, community-based testing models, including in non-traditional settings, such as schools and workplaces, and at border crossings. While self-testing is now a mainstay of pandemic control in many high-income countries, only a limited number of LMICs are implementing it due to a lack of affordable, quality assured self-tests, and clear guidance on when and how to use the tests, as well as what to do following test results.
Over 80 applicants responded to the RFP, and a shortlist of 26 companies was reviewed by a panel of external experts appointed by FIND. Criteria for the awards included the technical performance of the test, suitability for self-administration, and affordability for LMICs.
Following a due diligence process, contracts with four companies have now been finalised, all of which have COVID-19 self-tests in the final stages of commercial development. Additional partnerships are expected to be announced in the coming weeks.
The investment is funded by the German Federal Ministry of Education and Research (BMBF) through KfW and other donors, by way of grants to FIND. FIND will supplement this financial investment with technical support and will conduct an independent evaluation of the performance and usability of the tests in the settings of intended use. All support is dependent on a series of mutually agreed project milestones being successfully met.
The World Health Organisation (WHO) is currently drafting guidance on SARS-CoV-2 self-testing; data from the evaluations will be provided to WHO to support the development of global policy guidance and potential future regulatory submissions.
All four companies have either launched or are ready for commercial launch of their self-tests and have committed to the submission of regulatory dossiers for evaluation by WHO if/when possible, as well as transparency in their cost structure.
Marta Fernández Suárez, chief technology officer of FIND, said: “Self-testing can uniquely empower people to take control of their health, and has proved an important tool in the pandemic response in the Global North – but multiple barriers to access in LMICs means the Global South is being left behind yet again. The packages that these four companies are committing to are a major step towards making self-testing more accessible in LMICs, with volume commitments totalling at least 60 million tests per month and EXW pricing that is half that of current HIV self-tests.”
ACON Biotech has committed to a price of $1 “ex-works” (EXW) for their Flowflex SARS-CoV-2 Antigen Rapid Test, with a minimum volume commitment of 30 million tests per month to be made available in LMICs.
Osang Healthcare has committed to a price of $1.25 EXW for their GeneFinder COVID-19 Ag Self Test, with a minimum volume commitment of 10 million tests per month to be made available in LMICs.
Jiangsu Bioperfectus Technologies has committed to a price of $1.25 EXW for their bioPerfectus COVID-19 Ag Self-test Kit, with a minimum volume commitment of 10 million tests per month to be made available in LMICs.
Premier Medical Corporation has committed to a price of less than $2 EXW including distribution margin for their SureStatus COVID-19 Home Test, with a minimum volume commitment of 10 million tests per month to be made available in LMICs.
Winston Chen, general manager of ACON Biotech, said: “It is a great honour to work with FIND for the ACT-Accelerator diagnostics pillar, and we believe ACON could help people in LMICs to access high quality COVID-19 self-tests at an affordable price through this partnership. With their reliable performance, our Flowflex SARS-CoV-2 Antigen Rapid Tests have contributed a lot in the fight against the pandemic in the past two years. ACON is committed to developing and providing high-quality tests continuously to the world, especially to developing countries.”
Seung-Euk Hong, CEO of Osang Healthcare, said: “We are privileged to be a part of this FIND project. Our commitment at Osang Healthcare is to contribute to LMICs by supplying quality assured and affordable self-testing. We hope that all our efforts and dedication will help overcome the COVID-19 pandemic and eventually narrow the equity gap in the world in partnership with FIND.”
Jin Wei, general manager, R&D Center of Jiangsu Bioperfectus Technologies Co. Ltd, added: “We are very honoured to cooperate with FIND to bridge the gap between the LMICs and HICs (high-income countries) in COVID-19 self-testing. With more than ten years of experience in the global in-vitro diagnostic market for infectious diseases, Bioperfectus is pleased to participate in the ACT-Accelerator campaign and provide easy-to-use, accurate, and affordable self-testing kits for COVID-19. The cooperation means a lot to us and bolsters efforts in future R&D, manufacturing, quality control, sales & marketing of the COVID-19 self-testing kits.”
Nilesh Mehta, CEO of Premier Medical Corporation, commented: “As a global leader in rapid diagnostics for 25 years, we at Premier Medical Corporation understand the enormous positive consequences that high-quality and affordable diagnostics can provide to LMICs. We have always been committed to breaking the healthcare barriers in LMICs, and are proud to partner with FIND in helping us achieve that goal. Self-testing is an extremely important tool in long-term healthcare for all individuals, from all backgrounds, and we are extremely happy to help in bringing that vision to life.”
