Developing a reusable pregnancy test

Informazioni relative al progetto

Reusable preg test

ID dell’accordo di sovvenzione: 101114060

DOI

10.3030/101114060

Progetto chiuso

Data della firma CE 7 Giugno 2023

Data di avvio 1 Luglio 2023

Data di completamento 29 Febbraio 2024

Finanziato da

• European innovation ecosystems

Costo totale

Nessun dato

Contributo UE

€ 75 000,00

Coordinato da

PHARMISTA TECHNOLOGIES AB
Sweden

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

Periodo di rendicontazione: 2023-07-01 al 2024-02-29

Sintesi del contesto e degli obiettivi generali del progetto

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

Lavoro eseguito dall’inizio del progetto fino alla fine del periodo coperto dalla relazione e principali risultati finora ottenuti

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.

Progressi oltre lo stato dell’arte e potenziale impatto previsto (incluso l’impatto socioeconomico e le implicazioni sociali più ampie del progetto fino ad ora)

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.