Periodic Reporting for period 1 - Reusable preg test (Developing a reusable pregnancy test)
Reporting period: 2023-07-01 to 2024-02-29
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
• 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
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.
>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.
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.