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BioMensio mobile biosensing platform: the first truly palm-sized and accurate digital multi-drug test

Periodic Reporting for period 2 - BioMensio (BioMensio mobile biosensing platform: the first truly palm-sized and accurate digital multi-drug test)

Reporting period: 2020-03-01 to 2021-04-30

As the key to reducing drug related fatalities and injuries is using preventative tools more widely, the main goal of our project is to productise our platform so that it can be mass-deployed. The planned developments will turn our current prototype into a full drug testing device, which we plan to rapidly scale up for roadside, emergency medical care and workplace settings.

The specific objectives of our Phase 2 project are the following:
- Adding 6 drug families for parallel detection (sufficient for road-side and workplace use).
- Improving analysis sensitivity and detection speed down to 1-2 minutes.
- Preparing for mass manufacturing by redesigning hardware components and readout algorithms, and implementing quality processes to reach €5/cartridge and €1,5/MSMA sensor COGS.
- Preparing for operational scalability by evaluating partners for long term cooperation.
- Validating the market readiness of our drug analyser by testing it with selected partners.
- Finding new piloting partners for diagnostic device as well as food safety application piloting
- Conducting product demonstrations towards potential customers and new channel partners.
Work Package 1
WP1 has been progressing nicely. Main achievements include successful development work with algorithms and approaching our performance targets. In addition, we made progress regarding SARS-CoV-2 R&D work and conducted pre-clinical studies with several partners.
Work will continue on during the final period, mainly regarding cartridge development.

Work Package 2
WP2 includes some new tasks to correspond to our re-orientation regarding SARS-CoV-2 detection. Work has been progressing nicely, even though the pandemic has slowed us down. The main achievements include developing the new cartridge tester and starting testing with new cartridges.
During the final period, we will focus on improvements and also validation/piloting of the new reader.

Work Package 3
Piloting has been progressing slowly, however we have successfully conducted pre-clinical studies and are running negotiations with other partners. We also made progress with our reader’s UI.
The final year will focus on further trials and the selection of the final piloting partner, as well as preparation for market launch.

Work Package 4
WP4 faced some delays due to Covid-19, however we managed to improve our website and update our LinkedIn page regularly. We have also made progress regarding patents and have filed three patent applications.
Hopefully during the final project year, we are once again able to travel to conferences etc. and organise demonstrations.

Work Package 5
We have carefully followed the work plan set out in the Biomensio proposal. In order to achieve the desired outcome, we made some changes in the work plan. The amendment was approved and work is progressing nicely and with good results. All deliverables have been submitted.
To deploy drug testing as widely as detecting drunken drivers or employees, saliva-based solutions have a clear advantage. Saliva sample collection is quick and easy, non-gender specific, can be directly observed (no falsification), and can be done on-site with no need of special facilities. Advanced saliva testing technologies like ours can detect a person’s actual intoxication on the spot (not just prior consumption, which does not necessarily mean being under the influence at the time of taking the test). This is particularly relevant for traffic patrols, paramedics and workplaces.

Our Lab-on-a-Chip (LoaC) solution has several advantages to the commonly used solutions like Lateral Flow Test based methods. Our solution provides more rapid transport of sample liquid and reagents compared to LFT, and can therefore provide results faster and more reliably. Our solution is fully digital and connected to the Cloud offering workflow management benefits to the end user organization. We can provide also semi-quantitative or even quantitative results and we can upgrade the solution to handle the detection of more drugs than commonly available in the market. Our platform is adaptable to different applications and any liquid matrix. During the past period we have extensively evaluated feasibility for detection of infectious diseases. Rapid, sensitive, multianalyte detection, digitally displayed results and easy to use device are key advantages of our platform. By adapting surface chemistry, fluidics and data analysis, our platform can be applied to rapid diagnostic screening, e.g infectious diseases or allergens, rapid monitoring of food quality at production sites as well as environmental monitoring.