Research & Development

ACT-A Dx Knowledge Hub

The Diagnostic Journey

Diagnostics are a fundamental component of patient care as robust detection of diseases is essential to support an effective clinical plan. However, despite tremendous progress in global health, millions of people still lack the right diagnostic tools and technologies needed to combat health challenges. In the first phase of the diagnostic journey, research and development (R&D) helps address this challenge by translating an idea or concept into diagnostic tools and technologies, which can be used to identify conditions and address health needs.

Challenge

Reliable and affordable diagnostics have been identified as essential tools in the global response to combat the COVID-19 pandemic. Yet, when the pandemic hit, there were no COVID-19 in-vitro diagnostic (IVDs) tools and technologies available to detect or screen for SARS-CoV-2. Years of under-investment in diagnostics, coupled with a lack of coordination in R&D efforts, meant that both high- and low-income countries did not have the diagnostic tools and technologies to contain and effectively respond to the pandemic.

Approach

Without COVID-19 IVD tools and technologies, countries are unable to respond effectively. As the COVID-19 pandemic grew, monetary and non-monetary resources were mobilized through the ACT-Accelerator platform on a scale and timeline never seen before. The ACT-Accelerator Diagnostics Pillar partnership, through the support of its working group partners, has been using these resources to fast-track the development of quality-assured IVD tools and technologies for COVID-19 testing and surveillance.

With the support of partners, the following key activities were prioritized to support R&D efforts:

Develop fit-for-purpose, affordable, and accessible COVID-19 IVD products including molecular tests and antigen-detection rapid diagnostic tests AgRDTs for both professional use and self-tests to meet demand in low- and middle-income settings
Invest in molecular point-of-care tests and technologies that can detect multiple respiratory pathogens, specifically including SARS-CoV-2, with a single sample
In-country evaluation studies on usability and clinical performance of IVD tools to detect SARS-CoV-2
Create data solutions to accompany testing roll-out
Maintain a database and pipeline of products
Develop target product profiles to support the development of fit-for-purpose IVDs
Develop WHO International Standards for IVDs

Making an impact

R&D investments in COVID-19 IVD tools and technologies led to SARS-CoV-2 tests being one of the first tools deployed as part of the global response to the pandemic. The rapid development and rollout of these tests helped countries to understand transmission dynamics, create surveillance programmes, and implement timely medical (vaccines, oxygen, therapeutics) and non-medical counter-measures to safeguard communities. Notable R&D achievements are highlighted. To learn more about the R&D achievements and work, refer to the key learnings and resource section below.

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for first automated PCR tests
to become available

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for first rapid tests to be approved for emergency use

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commercialized COVID-19
tests independently evaluated

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commercially available
COVID-19 tests

molecular point-of-care multi-pathogen platforms being assessed

partnerships with digital
health developers

Key Learnings & Featured Work

Reflections on R&D

Leveraging the ACT-Accelerator experience, there are key lessons to expand the use of diagnostic tools and technologies for COVID-19 as well as other diseases of endemic and pandemic potential.