ViWipe: non-invasive paper-based diagnostics using menstrual blood

ViWipe is a paper-based, non-invasive system for menstrual blood collection and diagnostics of sexually transmitted infections (STIs) such as Human Papillomavirus (HPV), Chlamydia or Gonorrhea. We aim to offer a sustainable and accessible solution to current cervical screening methods that overcomes barriers in underserved and marginalised groups. This proposal aims to increase access equality by targeting individuals who are often excluded from or reluctant to participate in traditional testing due to stigma, discomfort, or embarrassment. Relying on patent-pending paper-based technology and molecular diagnostics, ViWipe aims to provide an accessible, comfortable and sustainable alternative to current testing methods. This proposal aims to achieve the following objectives: (1) developing a functional prototype, (2) establishing a commercialisation strategy including intellectual property protection and market analysis, and (3) conducting a small feasibility study to determine diagnostic accuracy and user acceptability. The prototype development includes optimising the sample collection design, choice of materials (non-woven fabrics, filter paper, plastics) and the adaptation of a power-free, paper-based DNA extraction method to enhance nucleic acid recovery and user-friendliness. The diagnostic workflow will be validated using spiked blood samples with synthetic DNA of HPV-16, HPV-18, Chlamydia trachomatis, and Neisseria gonorrhoeae, alongside bacterial cultures and viral surrogates, ensuring compatibility with molecular detection methods such as PCR and LAMP. After the workflow has been optimised, a small validation study in collaboration with BioIVT will assess diagnostic performance in menstrual blood samples from healthy individuals and patients with confirmed HPV or STI infections. This will also involve PPIE strategies including questionnaires, co-design workshops and research focus groups to ensure user-centred design. To further understand the market potential of ViWipe, a commercialisation strategy will focus on market research, intellectual property, stakeholder engagement, regulatory pathway analysis, and prototype scalability. ViWipe has the potential to transform women’s reproductive healthcare by offering an accessible, non-invasive, and sustainable solution. It supports early detection, reduces healthcare costs, and addresses gaps in diagnostic accessibility, particularly in low-resource settings. A robust risk mitigation plan, including prototype refinement, alternative sample sourcing, and workflow optimisation, will ensure project feasibility. This project lays the foundation for future commercialisation and clinical validation, ultimately advancing menstrual blood diagnostics as a viable alternative for reproductive health screening.