In order to have a framework of the musts and limitations for the final device, a list of all prerequisites that should be considered in the final device, both from end-costumers and regulatories point of view, along with the technological conditions for each partner was made.
The next step was to develop the proteomic and genomic biosensors and corresponding microfluidic manifolds. The latter was designed in a way that the least amount of blood, collected through fingerprick, is needed.
Based on the outcome of the proteomic and genomic biosensor development phase, two cartridges were designed and developed for the measurement of BTMs and genetic profile in a single drop of blood from fingerprick. These cartridges consisted of the corresponding proteomic and genomic biosensor and a microfluidic manifold to allow the flow of small amount of blood and reagents in the microsystem. After production the cartridges were packed to increase the shelf-life of the cartridges.
The final device with an integrated potentiostat has been finalized taking into account all prerequisites, both from end-costumers and regulatories point of view, along with the technological conditions for each partner. It was designed to be portable, user-friendly and answer the needs of both biosensors in different steps of sample preparation, measurement and reporting.
The next step was to validate and test the cartridges as well as the device and the potentiostat. The primary results showed the proteomic cartridge to be reproducible and accurate in measuring the target BTMs. The cartridge was also tested with the device and similar results were achieved. The device potentiostat (LabStat) was also validated using the commercial Autolab which also showed somehow comparable results and certain advantages for the LabStat, including simultaneous measurement of up to 64 electrodes in a couple of seconds. The device itself was also successful in finalizing all the tasks needed for sample preparation and testing when genomic cartridge was used.
As it was the objective to test the device in practice, two clinical studies have been designed and ethically approved. These studies were meant to be conducted in Austria (European population) and Iran (Middle Eastern population). The participants have been recruited and followed in the course of the project based on the submitted protocol. At the same time preliminary modeling simulations have been performed in order to have a better understanding of the needed variables and also the modeling techniques for the later clinical validation phases.
However, considering the delays due to the COVID 19 pandemic and BREXIT, it was, unfortunately, not possible to finalize the lab validation step in time and send the device to the clinical partners for final clinical validation before the contractual end of the PoCOsteo project, and this while the data of the clinical studies conducted in the past 4,5 years resulted in a new modeling simulation that might help with better prediction of fracture and osteoporosis.
