Accelerating diagnostic access project

ROSANNA PEELING: In this step, we want to tell you about a Wellcome Trust funded project aimed at exploring options to accelerate diagnostic access. For many years, we’ve seen that access to quality assured diagnostics for diseases of public health importance in the developing world is often delayed by unnecessary duplications of clinical performance studies or blocked by gaps and other barriers along the bench to bedside pathway of test development, evaluation, regulatory approval, policy development, and implementation. You can see from the figure here that the time it takes for companies to get a test through regulatory approval policy development and adoption can be as long as 5 to 10 years.

The length and complexity of this access pathway have a substantially increased cost for companies, leading to higher pricing, which in turn, reduce the impact that the diagnostic tests can have on patient outcomes and disease control, including epidemic response and antimicrobial resistance.

We have four objectives for this project. First, we will conduct stakeholder mapping to better understand the regulatory licencing and introduction to use policies and pathways for diagnostic tests within key countries in Africa, Asia, and Latin America. With a focus on diagnostics that can be used at the point-of-care or point-of-need, and are therefore widely accessible to people everywhere. Our second objective is to increase awareness amongst regulators, clinicians, public health experts, and policymakers of the bottlenecks, barriers, gaps, and duplications in current access pathways and policies for new point-of-care diagnostic tests. Our third objective is to identify possible solutions to overcoming bottlenecks, duplications, and fragmentation that impede rapid and timely licencing and introduction to use of point-of-care diagnostic tests.

Finally, based on the outcome of the first three objectives, we will develop policy briefs for a regulatory policy framework to accelerate licencing and introduction to use of new quality assured point-of-care diagnostic tests.

This figure shows the activities and the timelines for our project, which unfortunately has been delayed by the COVID-19 pandemic. We have started the regional consultations now to explore with countries and partners in each region options for accelerating diagnostic access. In March of 2022, we will convene a global event, during which we will synthesise all the findings from the industry and regional consultations, and work with global and regional partners to develop concrete plans to move forward. These will be captured in a series of policy briefs.

This project has been made possible by a grant from the Wellcome Trust to the London School of Hygiene and Tropical Medicine, The International Diagnostic Centre, and Chatham House in London. Our regional partners are the Africa Centres for Disease Control and Prevention, the Latin America Alliance for the Development of In Vitro Diagnostics, ALADDiV, and Association of Southeast Asian Nations, ASEAN.