By Deborah Borfitz

September 10, 2024 |  Women’s health startup Daye is on a mission to bridge the gender diagnostic gap with a tampon for the self-collection of vaginal and cervical fluids analyzed for biomarkers of sexually transmitted infections (STIs), including human papillomavirus (HPV). The tampon is a familiar device used by over 90% of the female population and much better suited to their anatomy than conventional vaginal swabs, according to Valentina Milanova, CEO and founder. 

Milanova was co-presenting at the recent Next Generation Dx Summit with Meri Beckwith, cofounder of Lindus Health, which collaborated on the so-called STAMP trial evaluating the efficacy of the diagnostic tampon for STIs and bacterial vaginosis (BV). The trial, enrolling 250 diverse participants between the ages of 25 and 65, found not only that the women preferred the diagnostic tampon over the swab, but outcomes compared favorably to a variety of other self-screening methods as well as a clinician-administered program. 

Data emerging from the trial were interesting enough that several journals have proactively approached Daye with offers of help to get the study published, Milanova noted. A sneak peek offered during the conference session indicates the Daye diagnostic tampon more often correctly identified BV, chlamydia trachomatis, Neisseria gonorrhoeae, and trichomoniasis vaginalis (linked to HPV) in comparison with the alternative sampling methods of vaginal swab, endocervical swab, urine, and culture.  

The clinical work conducted with Lindus Health enabled Daye to commercialize the diagnostic tampon in the UK and the US, having met the requirements of the European Medicines Agency, the Medicines and Healthcare products Regulatory Agency, and the Food and Drug Administration, Milanova reported. With the design of simple and convenient patient journeys, she added, it is expected that more people will start participating in STI and HPV screening programs “on their own terms.” 

The detection method begins when patients receiving a diagnostic tampon kit at their home or office. They then insert the tampon with an applicator that helps ensure it reaches their cervix, Milanova explained. Once they’ve used the tampon, they place it in a sterile pouch and send it off to the Daye lab for processing using quantitative PCR. Alongside the diagnostic data, patient self-reported outcomes and symptoms also get collected to “enable fast triaging and more accurate diagnosis.” 

Daye is “diagnostic assay agnostic,” she added. In the STAMP trial, the tampon was validated with several tests, including those sold by Roche, BD, Hologic, and Abbott. When test results are ready, they get published to a secure medical database that is accessible to patients along with aftercare options, including consultations with specialists and medication delivery.      

Unique Challenges

The success of STAMP trial depended on patient recruitment. Beckwith began his part of the co-presentation with the lessons learned by Lindus Health in running faster, more efficient infectious disease studies. The challenges to be overcome include the fact that studies are typically targeting diverse and evolving seasonal pathogens and the need to enroll participants at the right time within an infectious window, he said. 

In addition to this evolving disease landscape, ease of use is particularly important in infectious disease studies since they often take place at the point of care—potentially, a patient’s home. Determining the right study setting for sample donors who are infectious is “extra important,” said Beckwith.  

Among the ways Lindus Health has traditionally dealt with these challenges is to test for multiple strains in a single test to reduce the participant burden in these studies, including individuals who are asymptomatic, he continues. In past COVID studies, for instance, Lindus used a lateral flow test that also tested for influenza A and B viruses at the same time. 

So as not to miss the sometimes-narrow infectious window of 24, 48, or 72 hours, the company has found it helpful to build a registry of pre-consented sample donors who meet all the eligibility criteria of a study apart from being infectious and “then staying in very close contact with them, testing them, and enrolling them as soon as they display symptoms,” Beckwith said. Similarly, it has proven effective to pre-consent close contacts of people known to be infectious. The tactic was used to recruit thousands of patients a month for landmark COVID studies. 

Participants contending with a live infection are likely not keen on coming into a site to be tested, he continued, in referencing a partnership with healthcare technology company Tasso that offers blood collection devices for remote sample collection. Helpful companion approaches include remote video calls to explain key parts of the study or sampling protocol, sending trained nurses to participants’ home, and virtualizing study visits as much as possible. 

Deciding on an appropriate study model needs to take all these factors into account rather than getting “too hung up” on any one aspect of trial design, Beckwith said. Thinking collectively about how infectious a participant is, the course of symptoms, and the infectious window “can really make a big difference.”  

Enrollment is one of the biggest causes of delays in infectious disease studies, in turn causing the seasonal period of the condition of interest to be missed, he said. It is therefore “never good enough” to rely on a single recruitment and enrollment strategy. “We aways try to have multiple strategies ready to go at once and then we can double down on what is most effective as we’re conducting the study.” 

Direct digital marketing can be highly effective, Beckwith added, in addition to pre-consenting. He highlighted the value of working with community groups where infectious diseases are likely to spread and thus aid in more quickly reaching would-be participants. Infectious disease studies are unique, making it critical to understand the dynamics of what’s being targeted and how participants are likely to behave while infectious.  

Rapid Recruitment

As Milanova describes it, Daye is a gynecological health platform that develops novel medical diagnostic devices for women’s health. One of the key issues with clinical trials is that current recruitment systems aren’t well tailored to the needs of women. In fact, “until 1993, we didn’t actively recruit female participants into clinical trials and as a result there are still gaps in our ability to recruit [them].” Daye consistently faced this challenge until it started working with Lindus Health, she reported. 

“The female population is quite fed up with the current standard of care,” she said, as was discovered while developing the company’s self-sampling diagnostic tampon. The experience “can be quite invasive or intimidating,” on the one end featuring the speculum in painful pelvic exams causing bleeding in about 70% of patients and on the other self-sampling with a swab that they “don’t necessarily know what to do with.” 

Many women are unaccustomed to swabbing, as was learned during the UK’s YouScreen study where 13,000 participants did self-sampling with swabs to check for cervical cancer. “We [therefore] developed a novel self-sampling approach with a familiar device... the menstrual tampon, only in this case it is not utilized for the absorption of menstrual fluids,” she said. 

“Most of our patient population tend to be younger,” Milanova added, reflecting the age groups in which STI rates are highest. Conventional recruitment methods, such as distributing leaflets and posters at hospitals and doctor’s offices, may not resonate with this more social-savvy demographic. Many younger people prefer to be approached first via digital means, as was done successfully with the STAMP trial, she said. Other modern recruitment approaches adopted in the study included the use of lay language and many visuals. 

As a result, the study recruited about 500 participants in the first week of the campaign—a major feat for the “cost-mindful” company, said Milanova. “Gynecological health doesn’t get the lion’s share of either private or public funding, so being able to work with an organization like Lindus that facilitated a very efficient way to do patient recruitment made a difference in our ability to successfully execute and then close the gender research gap when it comes to diagnostics in STI and HPV.” 

‘Most Preferred Method’ 

The study with Lindus Health demonstrated that the Daye tampon increased the rates of sensitivity and specificity for common STIs and high-risk HPV strains due to improved sample collection. Adoption of the modern digital-first approach to recruitment meant the targeted patient populations were “more open to engaging with us.” Particularly high participation rates were seen for the post-trial focus groups where patient feedback on the overall experience with the diagnostic tampon relative to swabbing was solicited.  

“The swab was not designed for the vagina; it was designed for your nose and your throat and, like so many other areas of gynecological health, it was simply repurposed for vaginal health screening,” said Milanova. “In contrast, the tampon that we manufacture is designed specifically for the vaginal cavity,” covering the entirety of it in addition to the cervix. This enables the collection of much more bacterial mass and “pathogens from areas of the vaginal canal that might otherwise be left uncovered.”  

Participants in The STAMP study each had the Daye diagnostic tampon kit, and a separate self-sampling kit, delivered to their door, and were also invited to a clinic for a clinician-administered endocervical swab, she explains. Lab analysis of all the collected samples went “rather quickly” thanks to the fast patient recruitment.   

As-yet unpublished trial results reveal that the diagnostic tampon was “the most preferred method for self-sampling with the highest rates of diagnostic concordance among different age populations we were screening, and this was particularly important in the context of high-risk HPV strains where we want to minimize the rates of false-positives and false-negatives,” reported Milanova.