Daye, a women’s health startup, is advancing its diagnostic tampon for self-collection of vaginal and cervical fluids to enhance the detection of sexually transmitted infections (STIs) and human papillomavirus (HPV). The company presented data from its STAMP trial at the Next Generation Dx Summit, highlighting the tampon's efficacy and user preference over traditional vaginal swabs.
The STAMP trial, conducted in collaboration with Lindus Health, enrolled 250 participants aged 25 to 65. Results indicated that women favored the diagnostic tampon over swabs. The trial outcomes compared favorably to other self-screening methods and clinician-administered programs. According to Valentina Milanova, CEO and founder of Daye, several journals have expressed interest in publishing the study's findings.
Enhanced Detection Rates
Preliminary data from the STAMP trial suggest that the Daye diagnostic tampon more accurately identified bacterial vaginosis, Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis (linked to HPV) compared to vaginal swabs, endocervical swabs, urine samples, and cultures. This improved detection is attributed to the tampon's design, which covers the entire vaginal cavity and cervix, collecting more bacterial mass and pathogens.
Regulatory Approval and Commercialization
Based on the clinical work with Lindus Health, Daye has commercialized the diagnostic tampon in the UK and the US, meeting the requirements of the European Medicines Agency, the Medicines and Healthcare products Regulatory Agency, and the Food and Drug Administration. The company aims to simplify patient journeys to increase participation in STI and HPV screening programs.
Patient Experience and Sample Collection
The diagnostic process involves patients receiving a kit at home or in the office. They insert the tampon using an applicator to ensure it reaches the cervix. After use, the tampon is placed in a sterile pouch and sent to Daye's lab for quantitative PCR analysis. Patient-reported outcomes and symptoms are also collected to facilitate fast triaging and accurate diagnosis.
Daye emphasizes that its diagnostic approach is assay-agnostic, having validated the tampon with tests from Roche, BD, Hologic, and Abbott in the STAMP trial. Test results are published to a secure medical database accessible to patients, along with aftercare options, including specialist consultations and medication delivery.
Recruitment Strategies and Patient Preferences
Lindus Health played a crucial role in the STAMP trial by implementing effective patient recruitment strategies. Meri Beckwith, cofounder of Lindus Health, shared insights on running efficient infectious disease studies, emphasizing the importance of ease of use, especially in point-of-care settings. Strategies included testing for multiple strains in a single test, building a registry of pre-consented sample donors, and utilizing digital marketing and community groups for recruitment.
Milanova highlighted that the female population is often dissatisfied with the current standard of care, finding traditional methods like speculum exams invasive and self-swabbing confusing. The diagnostic tampon offers a more familiar and less intimidating alternative. The study recruited approximately 500 participants in the first week, demonstrating the effectiveness of modern, digital-first recruitment approaches.
Tampon Design and Improved Sample Collection
Milanova emphasized that the swab was not originally designed for the vagina, whereas the Daye tampon is specifically designed for the vaginal cavity, covering the entirety of it in addition to the cervix. This design enables the collection of more bacterial mass and pathogens from areas of the vaginal canal that might otherwise be left uncovered, leading to improved sensitivity and specificity for common STIs and high-risk HPV strains.