Periodic Reporting for period 1 - 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: 2023-07-01 to 2024-06-30
Daye is a female-founded gynaecological health startup on a mission to overcome historical gender biases and close the gender gap in medical research and innovation. The company aims to empower women and assigned female at birth (AFAB) individuals to take control of their menstrual, sexual, hormonal and reproductive health.
A core objective is to make gynaecological screening more accessible and convenient. Many women face practical and emotional barriers to HPV and STI testing, including difficulties arranging appointments, fear, and embarrassment. To address this, Daye has developed an innovative diagnostic tampon for at-home sample collection and analysis. The familiar tampon format enables comfortable, non-invasive self-testing and can improve accuracy by collecting a more comprehensive sample than traditional swabs.
Utilising EIC funding, Daye has clinical trials with 375+ patients, in partnership with the Scottish HPV Reference Laboratory, Hologic, and The University of Edinburgh, to assess the diagnostic tampon's efficacy, safety, and acceptability. .The technology has the potential to encourage higher screening participation, enable earlier detection of HPV and STIs, and ultimately improve health outcomes for millions of women worldwide.
Another key objective is to provide comprehensive insights into the vaginal microbiome, which plays a critical role in gynaecological health. Imbalances are linked to higher risks of infections, STIs, fertility issues, and cancers. Daye's vaginal microbiome screening service, launching alongside the diagnostic tampon, allows at-home testing and personalized results via a digital platform.
By combining a novel collection device, multi-omic testing, an accessible digital experience, and an engaged community, Daye aims to set a new standard of care in gynaecological medicine. The company's data-driven approach will fuel research to elucidate the complex relationships between the microbiome, STIs, and women's health conditions.
A core objective is to make gynaecological screening more accessible and convenient. Many women face practical and emotional barriers to HPV and STI testing, including difficulties arranging appointments, fear, and embarrassment. To address this, Daye has developed an innovative diagnostic tampon for at-home sample collection and analysis. The familiar tampon format enables comfortable, non-invasive self-testing and can improve accuracy by collecting a more comprehensive sample than traditional swabs.
Utilising EIC funding, Daye has clinical trials with 375+ patients, in partnership with the Scottish HPV Reference Laboratory, Hologic, and The University of Edinburgh, to assess the diagnostic tampon's efficacy, safety, and acceptability. .The technology has the potential to encourage higher screening participation, enable earlier detection of HPV and STIs, and ultimately improve health outcomes for millions of women worldwide.
Another key objective is to provide comprehensive insights into the vaginal microbiome, which plays a critical role in gynaecological health. Imbalances are linked to higher risks of infections, STIs, fertility issues, and cancers. Daye's vaginal microbiome screening service, launching alongside the diagnostic tampon, allows at-home testing and personalized results via a digital platform.
By combining a novel collection device, multi-omic testing, an accessible digital experience, and an engaged community, Daye aims to set a new standard of care in gynaecological medicine. The company's data-driven approach will fuel research to elucidate the complex relationships between the microbiome, STIs, and women's health conditions.
During the reporting period, Daye made significant progress on the technical and scientific development of its innovative diagnostic tampon for STI, HPV, and vaginal microbiome screening:
- Completed two clinical trials demonstrating increased sensitivity, specificity and patient compliance compared to standard-of-care screening methods, validating the tampon's ability to accurately collect samples and the extraction protocols to enable reliable testing.
- Established a comprehensive biobank in Europe and the US to bridge the gender health data gap. The biobank will store samples collected via the diagnostic tampon to power future research into gynaecological health. The biobank currently holds over 2000 samples.
- Built a unique medical database with over 10,000 female health profiles to inform continuous product development, predictive algorithms for health outcomes, and an improved understanding of gynaecological disease aetiology and treatment.
- Designed a proprietary manufacturing line to produce the novel diagnostic tampon at scale, including material science innovation to create a sustainable, water-soluble applicator that reduces plastic waste and is biocompatibility tested and approved for human use.
- Developed a state-of-the-art virtual care platform and mobile app to act as a centralized women's health hub toenable STI/HPV screening, symptom tracking, aftercare prescriptions, and telemedicine consultations, featuring an AI-powered chatbot to answer common questions.
- Achieved key regulatory milestones - the diagnostic tampon is now MHRA registered, CQC and UKAS accredited, and ISO13485 and GMP certified. Proprietary lab protocols and a secure portal were designed for end-to-end data protection.
In summary, Daye has translated its unique diagnostic tampon from concept to clinic, achieving critical technical, scientific and regulatory milestones.
- Completed two clinical trials demonstrating increased sensitivity, specificity and patient compliance compared to standard-of-care screening methods, validating the tampon's ability to accurately collect samples and the extraction protocols to enable reliable testing.
- Established a comprehensive biobank in Europe and the US to bridge the gender health data gap. The biobank will store samples collected via the diagnostic tampon to power future research into gynaecological health. The biobank currently holds over 2000 samples.
- Built a unique medical database with over 10,000 female health profiles to inform continuous product development, predictive algorithms for health outcomes, and an improved understanding of gynaecological disease aetiology and treatment.
- Designed a proprietary manufacturing line to produce the novel diagnostic tampon at scale, including material science innovation to create a sustainable, water-soluble applicator that reduces plastic waste and is biocompatibility tested and approved for human use.
- Developed a state-of-the-art virtual care platform and mobile app to act as a centralized women's health hub toenable STI/HPV screening, symptom tracking, aftercare prescriptions, and telemedicine consultations, featuring an AI-powered chatbot to answer common questions.
- Achieved key regulatory milestones - the diagnostic tampon is now MHRA registered, CQC and UKAS accredited, and ISO13485 and GMP certified. Proprietary lab protocols and a secure portal were designed for end-to-end data protection.
In summary, Daye has translated its unique diagnostic tampon from concept to clinic, achieving critical technical, scientific and regulatory milestones.
Daye has developed the world's first tampon-based screening service for HPV, STIs, and the vaginal microbiome. EIC-funded clinical trials have demonstrated the Diagnostic Tampon's improved accuracy and patient acceptability compared to standard methods like swabs and speculums. The familiar tampon format enables comfortable, non-invasive self-testing and collects a more comprehensive sample, reducing false negatives.
Key forms of impact include:
-Increased screening participation and earlier detection of HPV, STIs, and cervical cancer precursors by enabling non-invasive self-testing at home, breaking down barriers like fear, embarrassment, and difficulties scheduling clinic appointments
-Detecting infections and precancerous lesions earlier allows for more timely treatment, reducing the risk of cancer and other negative health outcomes
-By facilitating more widespread screening, the diagnostic tampon can help identify asymptomatic infections that would otherwise go undetected and untreated, and facilitate timely treatment to prevent onward transmission.
-Patient-led screening with the diagnostic tampon enables more efficient use of clinical resources and can reduce costs associated with in-office testing
-Identifying cervical cancer precursors early also lowers downstream costs by preventing progression to invasive cancer, which is far more expensive to treat
-Daye's unique biobank of patient samples and dataset of over 10,000 health records, will fuel research into the natural history of HPV infection, the role of the vaginal microbiome, and the aetiology of cervical cancer, to inform the development of more targeted prevention strategies, diagnostics and therapies.
Daye is driving adoption and success through several key initiatives. We are commercializing via retail partnerships with Boots and Walmart, expanding to Amazon, and making our Diagnostic Tampon FSA/HSA reimbursable in the US, which validates its medical necessity and boosts sales. We are rolling out to OBGYN and fertility clinics, offering a more accurate and cost-effective alternative to in-office testing, with pilots underway with major providers. Over the next year, we will be raising our Series B to scale up manufacturing, expand the B2B salesforce, and drive growth in the EU and US markets. Additionally, we are continuing R&D to optimize the product, expand its range of biomarkers, and develop predictive algorithms for conditions like cervical, endometrial, and ovarian cancer, as well as chronic gynaecological health conditions like endometriosis and PCOS. We are also developing a new version of the applicator to collect cervical tissues for cytology and pap smears.
Key forms of impact include:
-Increased screening participation and earlier detection of HPV, STIs, and cervical cancer precursors by enabling non-invasive self-testing at home, breaking down barriers like fear, embarrassment, and difficulties scheduling clinic appointments
-Detecting infections and precancerous lesions earlier allows for more timely treatment, reducing the risk of cancer and other negative health outcomes
-By facilitating more widespread screening, the diagnostic tampon can help identify asymptomatic infections that would otherwise go undetected and untreated, and facilitate timely treatment to prevent onward transmission.
-Patient-led screening with the diagnostic tampon enables more efficient use of clinical resources and can reduce costs associated with in-office testing
-Identifying cervical cancer precursors early also lowers downstream costs by preventing progression to invasive cancer, which is far more expensive to treat
-Daye's unique biobank of patient samples and dataset of over 10,000 health records, will fuel research into the natural history of HPV infection, the role of the vaginal microbiome, and the aetiology of cervical cancer, to inform the development of more targeted prevention strategies, diagnostics and therapies.
Daye is driving adoption and success through several key initiatives. We are commercializing via retail partnerships with Boots and Walmart, expanding to Amazon, and making our Diagnostic Tampon FSA/HSA reimbursable in the US, which validates its medical necessity and boosts sales. We are rolling out to OBGYN and fertility clinics, offering a more accurate and cost-effective alternative to in-office testing, with pilots underway with major providers. Over the next year, we will be raising our Series B to scale up manufacturing, expand the B2B salesforce, and drive growth in the EU and US markets. Additionally, we are continuing R&D to optimize the product, expand its range of biomarkers, and develop predictive algorithms for conditions like cervical, endometrial, and ovarian cancer, as well as chronic gynaecological health conditions like endometriosis and PCOS. We are also developing a new version of the applicator to collect cervical tissues for cytology and pap smears.