During the feasibility study, scientists at OpGen’s German subsidiary Curetis will work to develop a molecular testing panel with a comprehensive set of pathogen ID and AMR detection assays while also creating a simple, easy-to-perform workflow for testing using the blood culture systems available in target regions without the need for sample preparation. The collaboration’s goal is to find methods to adapt the A30 RQ platform—which is capable of test for up to 33 diagnostic targets from a single specimen—for use in environments often found in LMICs, such as those with continuous operation with unstable power grids.
“AMR is one of the most pressing health emergencies of our time, with the potential to undo decades of medical progress,” said Cecilia Ferreyra, director of AMR at FIND. “Simplifying blood culture systems so that the pathogen responsible for an illness and its resistance profile can both be identified quickly is crucial for halting and preventing this silent pandemic, especially in LMICs that bear the greatest burden of AMR.”
Based on the results of the feasibility study, co-funded by FIND with €700,000, which is anticipated to be completed by the end of the first quarter of 2023, OpGen and FIND will discuss the option of future collaboration and a commercialization agreement. Such a collaboration would be focused on bringing the Unyvero A30 RQ platform and the first products developed in the feasibility collaboration through the necessary clinical studies for marketing approval. Further, the two partners aim to develop the products that can be sold at a price point that will encourage the use of the tests to help address the unmet testing need for AMRs in LMICs.
OpGen noted that the platform, which uses a one-time use disposable cartridge and can deliver results in 30 to 90 minutes depending on the complexity of the test being run, is a good candidate for use in LMICs for rapid AMR detection due to the low cost of good associated with producing the assays.
“We are excited to partner with FIND, in demonstrating that our Unyvero A30 RQ platform is ideally suited to being used in LMICs for rapid detection of AMR which is a truly global issue that must be addressed in a multilateral and indeed global fashion,” said Oliver Schacht, president & CEO of OpGen in a press release. “The R&D contract and associated funding will support the required R&D efforts on our side and expedite such development.”
FIND (Foundation for Innovative New Diagnostics), based in Geneva, Switzerland, was created in 2003 at the World Health Assembly to address the pressing need for affordable diagnostic tests in LMICs. It was launched by the Bill and Melinda Gates Foundation and World Health Organization’s Special Programme for Research and Training in Tropical Diseases (TDR). Its initial focus was to speed up the development and evaluation of tuberculosis tests. Since then, its work has expanded to include improving diagnosis in other diseases including hepatitis C, HIV, malaria, and neglected tropical diseases.