Description
Countries in the Indo-Pacific region are committed to eliminating malaria. Dynamic malaria epidemiology and diverse socio-economic contexts in the region require multiple strategies and tools to achieve and sustain malaria elimination. This includes appropriate tools for screening and diagnosing malaria and neglected tropical diseases (NTDs). These tools must be responsive to changing diagnostic needs, including safely providing access to novel treatment options, identifying genetic mutations that hinder accurate diagnoses, and facilitating integrated surveillance efforts.
A consortium comprised of PATH (USA/Vietnam), Burnet (Australia), WEHI (Australia), will advance a portfolio of high-quality diagnostics to ensure equitable access to optimal malaria treatment options across genders and populations at risk of exclusion, as well as accelerate malaria elimination in accordance with national and regional aspirations in the Indo-Pacific. The consortium will advance diagnostic products that improve malaria case detection, ensure access to the best treatment options, and support strategies to reduce the malaria burden in difficult-to-reach communities. This will be achieved through three workstreams:
(i) Research and development. Diagnostic products as well as critical reagents that support a strong supply of high-quality malaria in-vitro diagnostic tests will be advanced through a rigorous stage gate process towards readiness for clinical evaluation.
(ii) Clinical evaluation. The consortium will conduct clinical evaluations in the Indo-Pacific region to support regulatory data packages as well as generate in-country evidence on the usability and value proposition of the products.
(iii) Availability and access. The partners will work with community, country, regional, and global stakeholders on health economic and operational activities that support sustainable integration of the products into the country health system, with a focus on ensuring equitable access to the products. This will include alignment with NTD strategies.
Given the critical need to include marginalized populations in malaria control efforts, a dedicated research agenda will ensure that gender equality, disability and social inclusion underpins the workplans for the activities under all three workstreams. The research agenda will seek to challenge assumptions and knowledge gaps on critical risks that undermine achieving equitable access to the products.
The program includes upstream development efforts to strengthen the supply and quality of next generation malaria rapid tests with novel antigens, antibodies as well as serology-based assays to assess the risk of relapse due to P. vivax infection. Clinical evaluations to support product registration will be conducted for new malaria rapid tests with improved analytical sensitivity for P. vivax and lines to address gene deletions, tests to screen for G6PD deficiency in novel use-cases, and a multiplex serological test to support a range of integrated surveillance and screening purposes. Finally, access to and availability of these products will be ensured through robust stakeholder engagement, value-proposition refinement, and assessments of cost-effectiveness.
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