Developing a reusable pregnancy test

Project Information

Reusable preg test

Grant agreement ID: 101114060

DOI

10.3030/101114060

Project closed

EC signature date 7 June 2023

Start date 1 July 2023

End date 29 February 2024

Funded under

• European innovation ecosystems

Total cost

No data

EU contribution

€ 75 000,00

Coordinated by

PHARMISTA TECHNOLOGIES AB
Sweden

Periodic Reporting for period 1 - Reusable preg test (Developing a reusable pregnancy test)

Reporting period: 2023-07-01 to 2024-02-29

Summary of the context and overall objectives of the project

Before initiating the project, we had verified the market need via 4 separate market studies, developed an MVP to show proof of concept, raised initial investments, secured IP and developed a first product design. For the WomenTechEU program, we wanted to intensify our focus around the technical development in order to raise a pre-seed investment of around €500 000. Hence, the overall objectives of this project was to;

• Develop our MVP into a miniaturized prototype
• Perform usability studies on the product design with end-users and
• Develop a regulatory strategy
• Secure IP in other parts of Europe
• Initiate strategic collaborations, both within Sweden and within Europe
• Intensify our focus on outreach/marketing and share knowledge among stakeholders

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

The overarching technical goal was to improve our sensor in terms of sensitivity, selectivity and reusability through optimizing the MIPs. We are pleased to say that we were successful in this quest with the following goals achieved;

>MIPs are robust and can withstand harsh conditions without loss of recognition properties.
>We can measure levels as low as 12.5 mIU/ml of hCG.
>No hook effect at high hCG levels.
>Preliminary data showing MIP preference to hCG over LH.
>Epitope specificity validated by surface plasmon resonance (SPR).
>We can repeatedly regenerate the sensor numerous times with reproducible signal response.
>Experiments indicate compatibility with urine.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

In order to successfully launch this product onto the market, we need to further optimize the sensor performance and the number of times we can obtain reproducible results when reusing it. Therafter, we need to make sure that the embodied system (hardware, software, sensor + strips) all function together. The last step of the development phase will be to perform a usability study and submit this data alongside our performance evaluation study to the FDA in the US and a Notified body here in Europe in order to get regulatory approval.