Gynae Health startup Daye and clinical trial company Lindus Health have launched a clinical trial for a Diagnostic Tampon designed to allow women and assigned female at birth (AFAB) individuals to conduct HPV and STI tests in their homes. Supporting Daye’s mission to close the gender health gap, its Diagnostic Tampon has the potential to transform women’s experience when being screened for HPV and STIs, enabling comfortable, noninvasive at-home testing. Using a tampon can also improve the accuracy of the test, as a tampon collects a bigger and more comprehensive sample than a swab.
Statistics indicate that roughly 8 in 10 individuals will contract HPV during their lives. However, many women and AFAB individuals face barriers to screening due to challenges in scheduling and emotional concerns such as fear and embarrassment. Daye, previously known for developing the world’s first Cannabidiol (CBD) Tampon, has now developed a Diagnostic Tampon to aid in the at-home collection and analysis of samples for HPV and STI detection to address these issues.
The upcoming trial will involve 375 participants from the UK and Italy. Primary focus is to assess the efficacy, safety, and acceptability of the Diagnostic Tampon. Lindus Health will manage the trial, managing participant recruitment, consent procedures, and data collection via their trial management software.
Commenting on the trial, Michael Young, Co-Founder of Lindus Health said: “With 8 in 10 people estimated to contract HPV in their lifetimes, and with complications leading to a range of cancers, it is vital that the industry looks to break down the barriers to testing and early detection. Through this trial, we hope to be instrumental in delivering a more comfortable alternative to screening for women – which could, in turn, save many lives.”
Valentina Milanova, Founder of Daye, added: “Time is of the essence when it comes to HPV and STI detection, as catching them early can help to prevent some of the negative effects and complications — but unfortunately many people still face practical and emotional barriers to getting a diagnosis. We are committed to making it easier for women and AFAB individuals to take control of their health, and at-home testing has a huge role to play in speeding up access to diagnosis and treatment. Nothing could be more familiar to women than the humble tampon. After completing clinical trials with over 600 participants, we are looking forward to starting clinical investigations with Lindus to further assess the role they could play in HPV and STI testing at a global scale.”