OpGen, FIND to collaborate on MDx testing for LMICs

2019 04 30 22 11 5866 Bacteria 400

OpGen on Tuesday announced it has signed an R&D collaboration agreement with FIND, the global alliance for diagnostics, to develop OpGen’s Unyvero A30 RQ platform for rapid pathogen identification and antimicrobial resistance (AMR) detection in low- and middle-income countries (LMICs).

The Unyvero A30 RQ platform is a sample-to-answer instrument that runs a disposable cartridge that can test up to 33 diagnostic targets from one specimen, OpGen said, adding that the platform's time to result can be 30 minutes for simple tests and around 45 to 90 minutes for most applications.

Given the favorable cost of goods profile of both the instrument and cartridge, the product lends itself to being deployed in LMICs with constrained resources, OpGen said.

An initial part of the current project with FIND involves a feasibility study for the rapid detection of AMR markers from blood cultures. For the feasibility phase, expected to conclude by the end of the first quarter of 2023, FIND is providing 700,000 euros ($699,237) in joint funding.

"AMR is one of the most pressing health emergencies of our time, with the potential to undo decades of medical progress," Cecilia Ferreyra, director of AMR at FIND, said in a statement. "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."

OpGen said that its R&D team at its German subsidiary, Curetis, will focus on developing a molecular test panel to provide a set of pathogen ID and AMR detection assays for the platform. Curetis also aims to develop a workflow compatible with available blood culture systems in target regions without any need for separate sample preparation steps, and to adapt some key features of the A30 RQ platform important for use in environments often found in LMICs, such as those with continuous operation with unstable power grids, OpGen said.

OpGen added that it may collaborate in the future and reach a commercialization agreement with FIND should the current project demonstrate feasibility.

A future collaboration agreement would aim to bring the Unyvero A30 RQ platform and initial application products through required clinical studies and regulatory approvals in LMICs, OpGen said.

The partners would seek to make the system and tests commercially available at an attractive cost profile to commercial distribution partners targeting LMICs, OpGen added.

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