NEW YORK – Medical technology startup Erada Technology Alliance said today that Tokyo-based Global Health Innovative Technology (GHIT) Fund has awarded a £1 million ($1.2 million) grant to facilitate production, testing, and validation trials of a saliva-based rapid diagnostic test for malaria.
The funding will support final product development to complete commercialization of the RDT, a lateral flow immunoassay, South Africa-based Erada said. It noted that the University of Florida secured the GHIT grant earlier this month and that the test's underlying technology is based on research conducted at the university.
The firm added that the tool, which it anticipates marketing as Salva!, incorporates a collection device that is easy to use so that healthcare professionals, teachers, and parents can quickly collect saliva.
The diagnostic test is being developed to identify a new P. falciparum protein biomarker (PSSP17) in saliva that could replace presently used parasite markers, such as Plasmodium histidine-rich protein-2 (HRP-2), Erada said. HRP-2 has become increasingly ineffective due to a growing prevalence of parasite mutations and the inherent difficulties and shortcomings of blood-based RDTs, the firm said.
The company anticipates launching the RDT in 2021 in collaboration with CellFree Sciences, Frontier Institute, Johns Hopkins University, and Oasis Diagnostics. The collaborators anticipate initiating field trials in the Democratic Republic of Congo or Uganda in the second quarter of 2020.
During these studies, Saliva!'s acceptability, usability, sensitivity, and reliability will be compared with the most sensitive molecular laboratory tests used in malaria detection.
GHIT's grant also covers design and small-scale production of 2,000 Saliva! kits that contain the saliva collection device and a lateral flow immunoassay cassette. Further, the grant covers the provision of quality-assured medical device production conditions enabling heat-stable, high-affinity recombinant humanized monoclonal antibodies for capture and detection of PSSP17 on the lateral flow test.
The overall objective of the project is to fulfill all the criteria for obtaining CE marking and subsequent World Health Organization prequalification of the Salva! kit, Erada said.
Baltimore, Maryland-based Johns Hopkins has provided an exclusive license for the technology to Erada.