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PATH, Mologic to Develop Malaria Rapid Diagnostic Test

NEW YORK (360Dx) – Mologic and PATH said today that they have entered an agreement to advance a new rapid diagnostic test (RDT) to support treating and eliminating Plasmodium vivax malaria.

PATH, an international nonprofit with a focus on improving health, especially among women and children, is supporting Mologic in commercializing the RDT and obtaining regulatory approvals.

Financial and other terms of the agreement were not disclosed.

More than 2.5 billion people worldwide are at risk of infection with P. vivax, a strain that prevails mainly in Southeast Asia and Latin America and causes relapsing illness. 

PATH is advancing a portfolio of tests for G6PD deficiency that meet requirements for use in settings where P. vivax malaria is close to elimination. As part of this effort, it is working with Mologic to develop a novel qualitative point-of-care RDT that has the potential to improve access to G6PD testing and support appropriate administration of primaquine.

PATH and Mologic said that they have optimized the Mologic RDT for use in environmental conditions typical in malaria-endemic countries, resulting in a test that is designed for use at the community level and other settings where malaria is commonly diagnosed and treated.

They noted that the RDT provides positive or negative results that can be easily interpreted by test users to determine if a patient has severe G6PD deficiency and is therefore at increased risk for side effects if treated with primaquine.

The qualitative G6PD RDT can provide a simple and affordable alternative to quantitative tests, which provide a numerical readout of G6PD levels but may be more expensive, and the first product variant is expected to come to market in 2019, they noted.

P. vivax is especially difficult to eliminate because the parasite can lie dormant in the liver and re-emerge, causing periods of relapsing illness. With each relapse, patients become progressively sicker, and can continue to spread the disease through mosquitoes to other members of the community.

UKAid and the Bill & Melinda Gates Foundation provided funding to PATH to support advancing new G6PD diagnostic tools