Developing a reusable pregnancy test

Información del proyecto

Reusable preg test

Identificador del acuerdo de subvención: 101114060

DOI

10.3030/101114060

Proyecto cerrado

Fecha de la firma de la CE 7 Junio 2023

Fecha de inicio 1 Julio 2023

Fecha de finalización 29 Febrero 2024

Financiado con arreglo a

• European innovation ecosystems

Coste total

Sin datos

Aportación de la UE

€ 75 000,00

Coordinado por

PHARMISTA TECHNOLOGIES AB
Sweden

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

Período documentado: 2023-07-01 hasta 2024-02-29

Resumen del contexto y de los objetivos generales del proyecto

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

Trabajo realizado desde el comienzo del proyecto hasta el final del período abarcado por el informe y los principales resultados hasta la fecha

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.

Avances que van más allá del estado de la técnica e impacto potencial esperado (incluida la repercusión socioeconómica y las implicaciones sociales más amplias del proyecto hasta la fecha)

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.