Daye Begins Clinical Trial for Diagnostic Tampon

Daye and clinical trial startup Lindus Health have launched a clinical trial for a Diagnostic Tampon that will enable women and assigned female at birth (AFAB) individuals to conduct STI and HPV tests at home. 

The trial will eventually enroll 375 patients across the United Kingdom and Italy to measure the diagnostic tampon’s efficacy, safety, and acceptability. Lindus Health is responsible for full trial delivery and supporting protocol drafting and submission packages, including recruiting and consenting participants, data collection through their proprietary trial management software, and project management. 

“With eight 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,” Lindus Health Co-Founder Michael Young said.  
“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.” 

Industry estimates indicate that roughly 80% of the planet’s populace will be infected with HPV at some point in their lives. However, many women and AFAB individuals face both practical and emotional barriers to screening, including difficulties in arranging appointments, fear and embarrassment. 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.
 
“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,” Daye Founder Valentina Milanova stated. “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.” 
 
Lindus Health is a London-based startup launched in 2021 that runs clinical trials three times faster than the old-fashioned industry standard. Clinical trials are the biggest bottleneck to advances in healthcare and by removing this constraint the firm aims to improve health for everyone. Lindus does this by using its pioneering industry-first platform that can manage a trial from start to finish. Lindus Health has delivered more than 80 trials across the United Kingdoim, United States, and Europe to tackle various conditions including diabetes, asthma, acne, social anxiety, major depressive disorder, hypertension, chronic fatigue syndrome and insomnia. The company has raised $24.5m from investors, including Peter Thiel, CREANDUM, Firstminute Capital,  Presight Capital, Seedcamp, Hambro Perks, Amino Collective and Calm/Storm. 
 
Daye is a female-founded gynaecological health startup that is developing solutions for menstrual pain management, vaginal health, and hormonal awareness. Founded in 2017, Daye invented the world’s first Cannabidiol (CBD) Tampon; the company is pioneering gynocentric research and creating products and services for period pain, menstrual care and at-home testing for STIs, HPV and vaginal infections. Daye was recognised by WIRED as one of London’s hottest startups in 2022 and 2019, and Daye’s founder, Valentina Milanova, was named on the 2023 Forbes 30Under30 Europe list.