The EU grant has helped us pushing forward our collaboration with hospitals and finding the group of bacterial pathogens where we need to focus to have the greatest clinical impact in terms of identifying resistance markers. These are known as the ESKAPE group: Escherichia coli, Staphylococcus aureus, Klebsiella pneumoniae, Pseudomonas aeruginosa, Enterococcus faecium/faecalis. They are responsible for two thirds of all healthcare associated infections .
On the one hand, our RUO platofrm, targetting microbiology and mass spectrometry research labs, is commercialized (TRL 9), and during this year we have extended its user base to more than 40 users from more than 25 institutions (see Figure 1). Main updates on the software are:
- Simplified data preparation workflow.
- Improved usability and language close to microbiology experts.
- New methods and modules (Heatmap, reproducibility analysis, FTIR data, SVM, PLS-DA cross validation and more).
- Sample identification and prediction, allowing building customised detection methods.
- Social features, allowing sharing research results with your contacts within or external to your own organisation.
More importantly, our clinical-IVD version are already in TRL 6-7 with some of the main resistance mechanisms in the clinically relevant ESKAPE group, with technology demonstrated with real samples in hospitals and moving towards demonstration in real clinical settings integrated with the laboratory workflow and multi-centre studies. Several publications have been submitted to international journals and relevant conferences. Figure 1 shows
After the feasibility study, our company is now ready to formally start clinical evaluation and regulatory phases. We have identified the most severe pathogen strains causing most of the infections for which we have a potentially good biomarker identified. The next step will be then to obtain both analytical and clinical validation for our method. Analytical validation is being done together with our collaborator in the Medical University of Vienna. Clinical validation will be done by multicentre studies coordinated by our collaborating hospitals and under the umbrella of the formal agreements we are signing with them currently. After validation, we will implement our quality management system and obtain certification ISO 13485 and probably 9001. This will lead to the corresponding notified body audits to obtain compliance with European IVDR. We plan to be in the clinical market during 2022. In the meantime, we’ll also use the experience to obtain USA FDA approval to be open to other markets besides Europe.
During the project we have also performed market study and optimise our market entry and commercialisation strategy. The project allowed us as well to attract talent, as we hired two Applications Specialists and partnered with a sales executive consultant.
