PATH DIAMETER

PATH DIAMETER

Consultation date: 05 August 2015

Malaria elimination strategy

Diameter is one of the 3 initiatives that the PATH has to address global challenges in malaria.

The aim of the DIAMETER team is to enable access to the most appropriate malaria diagnostic tools to support malaria elimination tactics. Starting in 2012, PATH received funding for the concept and technical feasibility stages of the development of a Plasmodium falciparum (Pf) infection detection test (IDT).

During the concept stage, the DIAMETER team conducted technology landscapes, a user needs analysis, and a market analysis. In close collaboration with the foundation and a technical advisory group, the DIAMETER team identified the histidine-rich protein 2 (HRP2) IDT as a high-priority investment and developed a preliminary target product profile for an HRP2 IDT with 10x improved limit of detection over existing commercial rapid diagnostic tests.

During the technical feasibility stage, PATH led new capture agent discovery activities and is currently in the process of evaluating promising antibodies. Additionally, PATH’s scientists and subcontracted partners have improved the scientific foundation for rational selection of HRP2 standards. PATH has advised partners and the foundation on the following initiative activities: development of baseline metrics on commercial rapid diagnostic tests, development of a regulatory strategy, development of a well-characterized repository of subclinical malaria-infected blood, and validation of preliminary target product profile requirements through impact modeling. The team and partners are performing laboratory evaluations of several partner IDT prototypes.

Through the recently initiated Biomarkers for Malaria Elimination (BIOME) study, the team seeks to identify the fraction of PCR-positive Pf-infected individuals a highly sensitive HRP2 IDT will detect.