UK gynaecological health start-up Daye and contract research organisation Lindus Health have teamed up to launch a clinical trial investigating a tampon capable of detecting human papillomavirus (HPV) and sexually transmitted infections (STIs).
The trial, overseen by Lindus Health, will enrol 375 patients across the UK and Italy to test the diagnostic tampon’s efficacy, safety and acceptability.
Female-founded Daye developed the diagnostic tampon for HPV and STI sample collection and analysis. According to London, UK-headquartered Daye, the tampon offers the advantage of collecting a bigger and more comprehensive sample compared with a conventional swab.
By integrating the test into an already regularly used healthcare product, the new tampon could provide a more accessible at-home alternative. Daye says that many women have difficulty in arranging appointments for sexual health testing, and there are emotional barriers to screening such as fear and embarrassment.
A 2021/2022 report on cervical screening data by the NHS found that 69.9% of eligible individuals aged 25–64 had last been adequately screened within the required number of years.
Daye founder Valentina Milanova said in a company statement: “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. At-home testing has a huge role to play in speeding up access to diagnosis and treatment.
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“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.”
Daye’s unique approach to menstrual care has already seen it disrupt much of the status quo in the women’s health space. In August 2023, the US Food and Drug Administration granted clearance for the company’s Nude Tampons, a product with gamma ray sanitisation to reduce the risk of vaginal infections.
The US women’s health market is expected to reach $153m by 2025, according to a report by GlobalData.