Commercialisation and scale up of a Vaginal Microbiome Screening service with a menstrual tampon collection device and a digital layer to provide diagnosis, disease risk evaluation and aftercare.

Project Information

VMS - Vaginal Microbiome Screening

Grant agreement ID: 190192897

DOI

10.3030/190192897

Project closed

EC signature date 28 June 2023

Start date 1 July 2023

End date 30 June 2025

Funded under

• The European Innovation Council (EIC)

Total cost

€ 3 794 918,75

EU contribution

€ 2 499 999,00

Coordinated by

TAMPONENI INOVATSII OOD
Bulgaria

Periodic Reporting for period 2 - VMS - Vaginal Microbiome Screening (Commercialisation and scale up of a Vaginal Microbiome Screening service with a menstrual tampon collection device and a digital layer to provide diagnosis, disease risk evaluation and aftercare.)

Reporting period: 2024-07-01 to 2025-06-30

Summary of the context and overall objectives of the project

Women’s health has long been underserved, with many facing barriers to essential gynaecological screenings like those for human papillomavirus (HPV) and sexually transmitted infections (STIs). These barriers include difficulty scheduling clinic visits, fear, embarrassment, and discomfort with traditional testing methods like swabs or speculum exams. Additionally, the vaginal microbiome, a community of microorganisms in the vagina, plays a vital role in health, influencing risks of infections, fertility issues, and even cancers. Yet, accessing comprehensive microbiome testing remains challenging for most women.

Tampon Innovations, trading as Daye, is a female-founded gynaecological health startup, aims to bridge these gaps by making screening more accessible, comfortable, and empowering for women and assigned female at birth (AFAB) individuals. The company’s mission is to overcome historical gender biases in medical research and innovation, ensuring women can take control of their menstrual, sexual, hormonal, and reproductive health. With funding from the European Innovation Council (EIC), Daye has developed an innovative Diagnostic Tampon that allows women to collect samples at home for HPV, STI, and vaginal microbiome testing. This familiar tampon format is non-invasive, easy to use, and designed to collect more comprehensive samples than traditional methods, improving diagnostic accuracy through increased sensitivity and specificity.

The project’s objectives are to validate the Diagnostic Tampon through clinical trials, to set up manufacturing, launch a screening service, and build a data-driven platform to advance women’s health research. By partnering with leading institutions like the University of Edinburgh, the Scottish HPV Reference Laboratory, and Hologic, Daye is conducting trials to confirm the tampon’s effectiveness, safety, and user acceptance. The technology aims to increase screening participation, enable earlier detection of health issues, and reduce the global burden of cervical cancer and STIs. Additionally, Daye is creating a biobank and digital platform to provide personalized health insights and fuel research into the vaginal microbiome’s role in conditions like infertility and cancer. The project aligns with EU priorities, including the EU Cancer Plan, by promoting innovative, accessible health solutions and supporting women’s health equity.

The expected impact is significant: millions of women worldwide could benefit from easier access to screening, leading to earlier interventions and better health outcomes. By removing barriers and enabling female patients to manage their health at home, Daye’s solution has the potential to transform gynaecological care and contribute to healthier communities.

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

Tampon Innovations has made significant progress in developing our Diagnostic Tampon for at-home HPV, STI, and vaginal microbiome screening. The project team has completed a large randomised controlled clinical trial, involving over 250 participants, in collaboration with the Scottish HPV Reference Laboratory, Hologic, and the University of Edinburgh. This trial demonstrated that the Diagnostic Tampon is more accurate and preferred by users compared to standard swab-based methods. The tampon’s design allows for comfortable self-testing and collects a more comprehensive sample, reducing the chance of missed diagnoses.

The project has also established a biobank with over 4,000 samples collected using the Diagnostic Tampon, stored in Europe and the United States. This biobank supports ongoing research into women’s health, addressing gaps in medical data. Additionally, Daye created a medical database with over 15,000 anonymised health profiles, providing valuable insights into gynaecological conditions and informing future innovations in the space, while helping bridge the gender data gap.

To ensure scalability, Daye designed a specialised manufacturing line to produce the Diagnostic Tampon sustainably. The tampon is now registered with the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and meets international quality standards like ISO13485 and GMP. Daye also developed a user-friendly mobile app and virtual care platform, enabling patients to access test results, track symptoms, obtain prescription treatments, and consult healthcare providers remotely. These achievements mark a significant step toward making gynaecological screening more accessible and environmentally friendly.

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)

Daye’s Diagnostic Tampon is the world’s first tampon-based screening service for HPV, STIs, and the vaginal microbiome, offering an impactful, affordable alternative to traditional methods. Unlike swabs or speculum exams, the tampon is familiar, non-invasive, and patient-friendly, encouraging more women and AFAB individuals to participate in regular screening. Clinical trials have shown it detects infections and high-risk HPV strains with greater accuracy, reducing false negatives and enabling earlier treatment. This could lower the incidence of cervical cancer, which affects over 600,000 women globally each year, according to the World Health Organisation.

The project’s impact extends beyond screening. By facilitating at-home testing, it saves time and reduces the need for in-clinic visits, easing the burden on healthcare systems and lowering costs. The biobank and health database are powering research into the vaginal microbiome’s links to fertility, infections, and cancers, paving the way for new diagnostics and treatments. Daye is also driving adoption through partnerships with major retailers like Boots and Walmart, and by making the tampon reimbursable through health savings accounts in the United States. These efforts position the diagnostic tampon as a game-changer in women’s health, with the potential to improve lives worldwide.

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