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Self-sampling HPV kits could screen an extra million women for cervical cancer

Self-sampling has already been introduced in several countries with the aim of increasing cervical screening participation rates

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Source: King’s College London

Self-sampling HPV kits could enable more than a million more women in England to participate in cervical screening over the next three years, new research has shown.

A new study has found that do-it-yourself human papillomavirus (HPV) tests could dramatically increase the rates of cervical screening uptake.

The YouScreen trial, led by King’s College London in partnership with NHS Cancer Alliances in North Central and North East London, NHS England and the NHS Cervical Screening Programme, provided self-sampling HPV kits to women who were at least six months overdue for their cervical screening.

Researchers found offering self-sampling kits to under-screened women when they attend their GP practice and by posting kits to women’s homes could boost the numbers screened in England by about 400,000 each year.

The findings, published in eClinicalMedicine, showed that this convenient test could be an effective way to tackle the problem of low cervical cancer screening attendance.

“Self-sampling has been hailed as a game-changer for cervical screening and we now have evidence in a UK population to show that it really is,” said lead investigator, Dr Anita Lim.

“Women who don’t come for regular screening are at the highest risk of developing cervical cancer. Cervical screening participation has been falling in England for over two decades. Currently, almost a third of eligible women aren’t getting screened regularly and in some parts of London this is as high as 50 per cent.

“It is crucial that we make cervical screening easier by introducing innovations like self-sampling, alongside the current cervical screening programme, to help protect more people from this highly preventable cancer. Self-sampling can do this by offering people choice and convenience.”

Self-sampling has already been introduced in several countries with the aim of increasing cervical screening participation rates, including the Netherlands, Australia, Denmark and Sweden.

Emerging evidence from other studies suggests that self-sampling tests are similarly good at detecting HPV, which can lead to pre-cancerous cells.

Women in the YouScreen trial used a vaginal swab to take their sample either at-home or at the GP practice. Samples taken at home could be posted for free directly to the laboratory for testing. If HPV was detected, a follow-up test was required.

The study, the largest trial of self-sampling for cervical cancer in the UK to date, offered HPV self-sampling kits to over 27,000 un- and under-screened women, aged 25-64 from 133 GP practices in north and east London between January 2021 and November 2021.

Around 8,800 women sent back self-samples; 64 per cent were from ethnic minority groups and 60 per cent from deprived populations. Approximately 13 per cent returned self-sample kits when mailed directly to them from the screening programme and 56 per cent returned a kit when it was offered at their GP practice.

Dr Lim said: “The YouScreen trial has given us the evidence we need to demonstrate that self-sampling helps get more women screened in England.

“It’s really encouraging that we received self-samples from groups that have been historically underserved including people from deprived and ethnic minority backgrounds, LGBTQI+, people with learning disabilities and victims of sexual violence.

Professor Peter Sasieni, head of the research group at King’s and now at Queen Mary University of London, said: “We are well on our way to turning cervical cancer into a rare disease in the UK. This is thanks to the NHS cervical screening programme, the HPV vaccine and the ability to now test for HPV.

“Unfortunately, women born before 1990 are unlikely to benefit from the HPV vaccine so regular screening is vitally important to protect those who have not been vaccinated from this cancer.

“YouScreen showed that this simple test is popular with both women and GP practices and could boost screening participation in England by over a million over three years. That in turn would help to accelerate the decline in cervical cancer rates.”

Mairead Lyons, a senior consultant to YouScreen from King’s College London, said self-sampling is a win-win for everyone.

“YouScreen demonstrated that for GPs, nurses and other healthcare professionals at general practice, being able to offer self-sampling to under-screened women when they attend for other appointments is a pragmatic way to deliver cervical screening to those at risk,” she explained.

NHS director of screening and vaccination, Deborah Tomalin, added: “It’s extremely promising that this study suggests simple DIY swab tests could have a really positive impact in supporting more women to take part in cervical screening from their own homes, and the NHS will now be working with the UK National Screening Committee to consider the feasibility of rolling this out more widely across England.

“In the meantime, if you are invited for cervical screening by the NHS, it’s vital that you come forward – it could save your life and remains vital towards our ambition of eradicating cervical cancer in England within the next two decades.”

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Congress urged to invest over $20bn to close women’s health gap

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Congress is being urged to invest US$20bn over 10 years to close the women’s health gap.

The American College of Obstetricians and Gynecologists, the Society for Women’s Health Research and the Women First Research Coalition have unveiled the National Strategy to Close the Women’s Health Gap.

The framework calls for a coordinated national effort to improve women’s health research, care and outcomes.

It says women make up more than half of the US population, but their health needs across conditions and life stages have been understudied and underserved for decades.

Kathryn Schubert, president and chief executive of the Society for Women’s Health Research, said: “The women’s health gap has persisted for far too long.

“This strategy offers Congress a road map to improve health outcomes, drive innovation, and build a healthier future for women, families, and communities.”

The strategy notes that Congress required women to be included in National Institutes of Health-funded clinical research through the NIH Revitalization Act in 1993.

However, it says major gaps remain in women’s health research, clinical care and how evidence is put into practice.

The plan proposes US$7bn for research and innovation, including expanded federal investment in women’s health research across the NIH, VA, DoD and the Advanced Research Projects Agency for Health.

It would also establish a Women’s Health Research Interdisciplinary Fund at the NIH and create a national network of Women’s Health Centers of Excellence.

The centres would aim to accelerate the translation of research into clinical care and serve as training sites for researchers and clinicians.

A further US$1bn would be used for regulatory coordination and modernisation, including cross-agency collaboration and work to address sex differences in drug and treatment approvals.

Sex differences are biological differences between females and males that can affect disease risk, symptoms, treatment response and side-effects.

The funding would also support updated NIH tracking systems for women’s health research investment and publication standards on how sex as a biological variable is considered in research.

The strategy calls for US$4bn for data and evidence infrastructure, including a public-private partnership focused on women’s midlife health data.

It would also convene a public workshop to review existing women’s health research datasets and develop common data elements to fill gaps and make datasets more widely available.

Another US$7bn would go towards strengthening the clinical and research workforce.

This would include career pathways, loan repayment programmes, a women’s health clinical workforce loan repayment programme modelled on the National Health Service Corps and interdisciplinary training.

The workforce measures would include particular emphasis on rural and underserved areas.

The final US$1bn would support public awareness and education campaigns to improve health literacy, preventive care and participation in women’s health research.

Health literacy means a person’s ability to find, understand and use health information to make decisions about care.

The campaigns would use digital and traditional media developed in consultation with patient advocacy organisations and relevant medical societies.

Sandra E Brooks, chief executive of the American College of Obstetricians and Gynecologists, said: “Closing the women’s health gap requires not only funding research, but also investment in the people who conduct that research and those who translate research findings and discoveries into better patient care.

“Strengthening the women’s health research and clinical workforce is critical to accelerating the innovation needed to improve health outcomes for women.”

The strategy says women have higher annual out-of-pocket healthcare costs than men and live 25 per cent of their lives in poorer health.

Supporters say this strengthens the economic and public health case for long-term congressional investment.

The framework has been endorsed by organisations across women’s health, ageing, heart disease, autoimmune disease, cancer, reproductive medicine and neurological conditions, including the Women’s Alzheimer’s Movement at Cleveland Clinic, the National MS Society and UsAgainstAlzheimer’s.

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Stardust period tracker shares health data, study reveals

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Stardust shared sensitive period tracking data with third-party analytics firms, according to new privacy research from Mozilla.

The findings expose a privacy divide in femtech, where users often trust apps with highly sensitive reproductive health information.

The research was carried out by Mozilla’s Privacy Not Included team, which tested several period tracking apps.

It found that Stardust, a period tracker used by millions, shared users’ reproductive health data with analytics companies, a practice the research said contrasted with its privacy-first marketing.

Analytics companies collect and examine information about how people use digital products, often to help businesses understand user behaviour or improve marketing.

The findings raise questions about whether privacy promises made by health apps match what happens to users’ data.

According to research reported by TechCrunch, one other period tracking app tested by Mozilla received what researchers called a “squeaky clean” rating, suggesting similar services can operate without sharing sensitive health data in the same way.

Period tracking apps have come under greater scrutiny in the US since the 2022 overturning of Roe v Wade, which removed federal constitutional protection for abortion.

Some users and privacy advocates have warned that menstrual and reproductive health data could potentially be sought in legal cases.

The research also points to a broader regulatory problem for consumer health apps.

In the US, many health apps are not covered by HIPAA, the health privacy law that applies to medical providers and some healthcare organisations.

That means some consumer apps may be able to collect, share or monetise sensitive health data under rules that differ from traditional healthcare privacy protections.

The femtech market, estimated in the report at US$50bn, has grown quickly, but privacy regulation has not always kept pace with app development.

Stardust had not publicly responded to Mozilla’s findings at the time of the original report, and its privacy policy remained live on its website.

The issue is particularly sensitive for period tracking because the data can reveal patterns around fertility, pregnancy, contraception and reproductive health.

Mozilla’s wider Privacy Not Included initiative has examined consumer technology products for privacy and security concerns since launching in 2017, including connected devices, children’s toys and health apps.

The findings come as US lawmakers continue to debate stronger federal privacy rules for sensitive health information collected by consumer apps.

The American Data Privacy and Protection Act, which has been stalled in Congress since 2023, includes provisions addressing sensitive health information collected by consumer apps.

Experts have also warned that anonymised health data can sometimes be re-identified when combined with other information, such as location data.

Re-identification means linking supposedly anonymous data back to a specific person.

A 2019 study found that menstrual cycle data combined with location information could identify individual users with high accuracy.

State-level privacy laws in places such as California, Virginia and Colorado have also given consumers new rights around personal data, although enforcement can vary.

Privacy advocates say the research underlines the need for clearer data practices, stronger safeguards and greater transparency in femtech.

For users, the findings are a reminder that health apps do not automatically protect health information in the same way as healthcare providers.

The report suggests period tracker companies that put privacy first may be better placed to build trust in a market where long-term use depends on confidence.

Mozilla’s investigation suggests privacy promises in femtech do not always match practice, and that period trackers can function without sharing sensitive user data in the same way.

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Entrepreneur

Juno Bio secures US$3.8m for precision diagnostics

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Juno Bio has secured US$3.8m to expand its diagnostics platform for vaginal health and reproductive care.

The funding round was led by Ada Ventures, with participation from Artesian, Entrepreneur First and Illumina Accelerator.

The women’s health startup said the seed funding will support the launch of its first CLIA-certified sequencing laboratory in Oakland, California, and a new clinical vaginal microbiome and STI test for healthcare providers.

CLIA certification refers to US laboratory standards for testing human samples used in diagnosis, prevention or treatment decisions.

Dr Leighton Turner, co-founder and chief scientific officer of Juno Bio, said: “The vaginal microbiome is still one of the least understood systems in the body at a clinical scale.

“With our lab, we’re starting to build a measurement standard that clinicians can actually use.

“We believe the level of detail from this kind of testing can meaningfully improve how vaginal healthcare is provided.”

The company is developing precision diagnostics for vaginal health, where patients can experience recurring symptoms, inconsistent diagnoses and treatments based on trial and error.

Juno Bio said bringing testing in-house gives it greater control over the process, from sample handling to results, while allowing it to refine its technology and build what it says is one of the largest datasets focused on the vaginal microbiome.

The vaginal microbiome is the community of bacteria and fungi that naturally live in the vagina. Changes in this balance can be linked to infections, symptoms and wider reproductive health issues.

Juno Bio’s newly launched clinical test examines the wider vaginal microbiome and screens for four common sexually transmitted infections, or STIs.

Rather than looking for a single cause, the test is intended to give clinicians a broader picture of what may be contributing to symptoms.

Juno Bio says this matters because multiple infections can occur at the same time and microbiome changes may be linked to fertility, menopause or recurrent infections.

Dr Anna Powell of Johns Hopkins said: “Vaginal microbiome testing has the potential to significantly reshape how we understand and manage vaginal health, particularly for patients with recurrent or unexplained symptoms.

“While the field is still evolving, advances in sequencing and data interpretation are moving us closer to a future where more personalised, microbiome-informed care can complement existing diagnostic approaches.”

Check Warner, co-founding partner at Ada Ventures, added: “Juno Bio is setting a new standard for how vaginal health is understood and managed.

“What they’ve built at this stage, with this level of capital efficiency, is exceptional.

“We’re proud to support the team as they scale their clinical infrastructure and continue leading innovation in this critically underserved category.”

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