EOI - Driving equitable access to fit-for-purpose antigen-detecting rapid diagnostic tests for COVID-19

Background

Since the beginning of the COVID-19 pandemic, molecular testing has played a critical role in the management of suspected cases as well as contact tracing worldwide. Testing capacity, however, remains highly centralized, and often insufficient to meet the current demand. While countries in all regions have experienced these challenges, the needs are more acute in low- and middle-income countries (LMICs), where fragile health systems and exclusive reliance on global supply chains have often left LMICs unable to access much-needed tests. This situation is further compounded by the lack of reliable, affordable and easy-to-use rapid tests for clinical diagnosis of COVID-19. While such tests would be beneficial to high-income countries (HICs), they are critical for establishing testing programmes in LMICs.

An estimated 500 million COVID-19 diagnostic tests will be needed in LMICs over the next 12 months, 75% of which in decentralized settings (i.e. primary healthcare, community-level care, hospital triage). There is emerging consensus about the important role that SARS-CoV-2 antigen-detecting rapid diagnostic tests (Ag RDTs) will play in filling this gap, as the primary diagnostic for active infection detection in decentralised settings where timely molecular testing is not available. A target product profile (TPP) for the use of Ag RDTs in this context will be published by WHO in the near future (this EOI will be updated to include a link to the publication as soon as it is available).

 

Scope

This EOI aims to fill current diagnostic gaps in the detection of active SARS-CoV-2 infection for case management and contact tracing purposes in decentralized settings. In this context, a test that detects the virus in a user-friendly, field-appropriate format is desirable. While both point-of-care nucleic acid testing platforms and Ag RDTs would be appropriate in these settings, this call is specifically for Ag RDTs.

The focus is on accelerating supply and availability of quality-assured and regulatory-approved fit-for-purpose Ag RDTs that at least meet the minimal WHO TPP requirements, with preference given to those that meet some or all of the optimal requirements. Until the TPP is published, interim high-level guidance on performance and usability targets is provided in Appendix 1.

The ACT-Accelerator Diagnostics Pillar (ACT-A Dx) will engage end-to-end, from the development and deployment process to driving access to these fit-for-purpose Ag RDTs. This will include accelerating development, facilitating regulatory approvals, and increasing production capacity, addressing supply chain challenges, establishing mechanisms (such as volume guarantees) to de-risk the market, and strengthening local capacity for development and deployment of new tests within national testing strategies. This EOI is just one of several mechanisms being developed by ACT-A Dx, and is focused on the downstream activities of product development and manufacturing scale-up. Any support provided through this EOI will require a commitment to supplying Ag RDTs to LMICs under global access terms.

 

Proposals and business partnerships are sought in two areas: 

• Accelerating development and market entry of improved, quality-assured SARS-CoV-2 Ag RDTs for expanded use in LMICs.
• Rapidly creating the supply conditions (manufacturing capacity, diversity of supplier base, affordability) to meet the needs of LMICs 

Interested Parties

Proposals are sought from innovators, RDT developers, IVD manufacturers, and LMIC-based diagnostic stakeholders interested in:

• Expanding their own production capacity, with commitment to LMIC supply
• Supporting geographic diversification of manufacturing in one or more LMIC regions with local partnerships, including (but not limited to) contract manufacturing for open-label products
• Partnering with readily available high-quality manufacturing capacity globally, or offering their own excess production capacity to other developers Licensing and/or technology transfer 

Proposals should be submitted in PowerPoint, with no more than 20 slides that include the following information:

• Value proposition and expected impact
• Vision for proposed business model supporting the supply of tests in LMICs
• Summary of evidence supporting any claims (e.g. product performance, manufacturing capacity)
• Proposed activities, deliverables and timeline
• Freedom to operate and existing licensing agreements
• Estimated funding need and other support requirements (such as a request for matchmaking)
• Partnerships (if relevant) and role of each entity
• Team / key staff
• Declaration of any relevant interests

 

This EOI opened on 4 July 2020, and the first deadline for receipt of submissions is 24 July 2020, 23:59 CET. Subject to additional funding commitments, a second deadline will be established to enable inclusion of manufacturers who are not yet at a stage where they can submit a proposal, followed by a rolling process for further submissions

 

For detailed ToR, click here

Tags Healthcare and Healthtech Others