NEW YORK (GenomeWeb) – Genedrive announced today that it has partnered with the Foundation for Innovative New Diagnostics (FIND) to begin a study to evaluate the firm's hepatitis C Virus ID Kit.
Genedrive's HCV ID Kit runs on the firm's portable molecular diagnostics platform and is designed for use in low-resource settings, delivering results in 90 minutes. The platform uses PCR amplification and melt curve analysis to rapidly amplify and detect target nucleic acid sequences without the need for nucleic acid isolation.
As part of the agreement, FIND will lead evaluation studies on the firm's assays in Cameroon and Georgia between September 2018 and May 2019. The studies are designed to confirm the assay's accuracy across a variety of genotypes, as well as to assess "usability in the intended market setting," the firm said.
In addition, Genedrive will provide product in-kind to support the study.
"Positive outcomes should further facilitate our commercialization activities in these regions, as well as provid[e] important clinical field data that others look to as they decide to implement Genedrive in their own specific settings," Genedrive CEO David Budd said in a statement.
FIND will integrate the evaluations of the firm's kit as part of its wider HCV diagnostics efforts. The group is the lead partner on a multi-year, multi-country project funded by Unitaid to advance development of simple HCV diagnostic tools.
Earlier this week, FIND signed a memorandum of understanding with Clinical Research Malaysia to develop a new strategy to diagnose HCV in decentralized primary healthcare facilities. Last month, FIND awarded grants to several firms to develop new HCV diagnostics, as well.