Development of IVD and RUO analytical software for a European project
Desktop application in .NET 6 using C#, WPF graphical subsystem, and SQLITE embedded database.
GeneFirst, a UK-based molecular diagnostics company, works in the fields of infectious disease, cancer diagnostics, and personalized medicine.
They have developed an innovative technology that designs multiplex qPCR assays allowing for simultaneous detection and differentiation of up to seven pathogens per fluorescence channel. Using this technology, GeneFirst already came up with a diagnostic assay for the detection of HPV viruses.
The company set to develop and validate together with 4 European partners a solution that offers high-quality and comprehensive diagnostics for patients showing respiratory infection symptoms, including the SARS-CoV-2 virus.
As part of the system, the aim was to develop analytical software, compliant with European IVD requirements. Since their initial software was developed for research use and, therefore, was not compliant with IVD regulations, the company was looking for a partner to overcome this challenge: BioSistemika’s expertise turned out to be a perfect fit.
BioSistemika developed a desktop software solution based on our expert qPCR knowledge and previous experience with the development of intuitive and easy-to-use software for IVD medical devices.
The solution needed to be compliant with European IVD requirements and associated harmonized standards.
Software screens
To support IVD analytical software version certification as an in vitro diagnostic medical device in the EU, all the software-related documentation required by the IVDR was prepared and delivered with the software.
The final solution offers a simple and intuitive design to quickly grasp its functioning and ways to be used.
The project was supported by Innovative Health Initiative 2 Joint Undertaking.
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