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FDA approves menstrual blood diagnostic device in Thailand

The developers say the device could provide an alternative diagnostic test to the Pap smear

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The US biotech company Qvin has announced FDA approval in Thailand for its menstrual blood diagnostic device.

Qvin has developed its Q-Pad technology to provide women with accessible and “non-invasive” diagnostic testing for prevention and early detection.

The company aims to eliminates common barriers to traditional laboratory testing, which can be difficult due to lack of access to care, cultural shame, religious beliefs or financial means.

Thailand, where the device was recently approved, has a population of 30 million women ages 15 years and older who are at risk of developing cervical cancer.

However, the FDA approval is hoped to allow thousands of women to have access to menstrual blood testing and test for HR-HPV.

Q-Pad, a menstrual pad used twice during menstruation, includes a removable cotton strip which is sent to a laboratory for clinical testing. Users are then sent their lab report results through an app or through their healthcare provider.

According to the developers, the device will provide an alternative diagnostic test to the Pap smear, providing an accessible and non-invasive way to screen for HR-HPV.

“As part of our efforts to help women in Thailand prevent cervical cancer, we believe Qvin’s Q-Pad is one of the most innovative ways to screen for HR-HPV earlier,” said Dr Chairat Panthuraamphorn, managing director and CEO at Samitivej Hospital.

“We believe this is a progressive, modern-day approach to cervical cancer prevention and an excellent alternative to Pap smears in our hospital system.”

Dr Sara Naseri, Qvin CEO and co-founder, said: “Receiving FDA approval in Thailand is exciting and contributes to our vision of a world where women do not die from cancers, like cervical cancer, that are entirely preventable if caught early.”

“Approval not only marks a milestone on our journey to move the study of women forward, but it means we can provide accessible testing to millions of people in Thailand to identify HR-HPV earlier to try and eliminate cervical cancer there and look for more countries to follow.”

Dr Paul D. Blumenthal, Professor of obstetrics and gynaecology at Stanford University, said: “It is well known that regular HPV screenings save lives by leading to detection of cervical pre-cancer, which enables patients and providers to treat it effectively before it turns into cervical cancer, a leading cause of death for women globally.

“I’m thrilled that the Q-Pad has been cleared in Thailand, which has high cervical cancer rates.

“Access to testing means users will be able to take control of their health easily and efficiently.”

The FDA Thailand regulatory clearance was completed in collaboration between Qvin, N Health Laboratories and Bangkok Health Research Center (BHRC).

In addition to regulatory clearance, Bangkok Health Research Center plans to conduct a 1,500-person comparative study on HR-HPV using both Q-Pads and Pap smears.

The data collected will be used to further understand the prevalence of HPV and cervical cancer in Thailand and develop strategies to screen for HR-HPV sooner and save lives.

Menopause

Menopause frequently missing from electronic health records – study

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Menopause is often absent from women’s electronic health records, a study of nearly 396,000 women has found.

Researchers found menopause appeared almost seven times more often in participant surveys than in electronic health records (EHRs).

The findings suggest important reproductive health information, including age at menopause, may often be missing from health records used for research.

Audrey Hendricks, associate professor of bioinformatics at CU Anschutz and the study’s principal investigator, said: “Ultimately, we cannot study what we do not measure. We cannot treat what we do not know.

“Menopause has enormous implications for women’s health, but if we don’t consistently capture when menopause occurs and other important reproductive health information, we limit our ability to understand how this transition affects disease risk and health outcomes.”

Researchers at the University of Colorado Anschutz analysed data from women taking part in the National Institutes of Health’s All of Us Research Program.

They compared menopause information reported by participants in surveys with menopause diagnoses recorded in their electronic health records.

Around 193,000 menopause observations were identified in survey data, compared with approximately 28,000 diagnoses in EHR data.

Menopause was documented in electronic health records for only about 7 per cent of women in the dataset.

Nearly all participants with a menopause diagnosis recorded in their EHR also reported menopause in survey data. However, substantially fewer women had menopause documented in their health records.

Other important information was also frequently unavailable, including age at menopause, which researchers may use when examining links between menopause and chronic disease risk.

Menopause is a physiological transition that can affect cardiometabolic health and many other aspects of women’s health.

Researchers said relatively little is known about how factors including the timing and type of menopause influence health outcomes across diverse populations.

Large-scale programmes such as All of Us combine participant surveys, electronic health records and genomic data, but menopause-related research depends on relevant reproductive health information being available.

Missing menopause information can make it harder to investigate how the transition relates to health and disease.

The findings may also help researchers using All of Us data define menopause-related study populations, design studies and estimate how many participants are needed.

Hendricks said: “We have an enormous opportunity to use large-scale datasets to understand women’s health across the menopause transition and to identify who may be at greater risk for disease.

“But we need to make sure that the information researchers need is actually being collected.

“We must do a better job of capturing women’s health information, including reproductive health and measures related to menopause.”

Researchers said more complete and consistent collection of menopause and reproductive health information could help future studies examine factors such as age at menopause and their relationship with disease risk and health outcomes.

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Fertility rate in England and Wales hits record low, new figures reveal

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The fertility rate in England and Wales fell to a record low of 1.39 children per woman in 2025, down from 1.41 a year earlier.

New figures show that parts of London and cities with major universities accounted for many of the areas with the lowest local fertility rates.

The City of London recorded the lowest rate in 2025 at 0.37 children per woman, followed by Cambridge at 0.87 and the London boroughs of Islington and Westminster at 0.90.

The Office for National Statistics (ONS) defines the fertility rate as the average number of live children women would expect to have over their childbearing lives.

Brighton & Hove recorded a rate of 0.95, followed by Southwark at 0.97 and Norwich at 0.98.

Exeter, Oxford and York, along with the London boroughs of Camden and Hammersmith & Fulham, each recorded 1.01 children per woman.

At the other end of the table, Pendle in Lancashire and Luton in Bedfordshire had the highest rate at 1.93.

They were followed by Oldham in Greater Manchester at 1.87, Bradford in West Yorkshire at 1.84 and Barking & Dagenham in London at 1.83.

The overall fertility rate for England and Wales declined from 1.41 in 2024 to 1.39 in 2025.

A rate of around 2.1 is needed for a population to remain stable over time when the impact of migration is excluded.

Twelve of the 25 local authorities with the lowest fertility rates in 2025 were in London.

In Wales, Swansea recorded the lowest fertility rate at 1.18, while Carmarthenshire, the Isle of Anglesey and Newport each had the highest rate at 1.48.

There were 585,396 live births in England and Wales in 2025, down from 594,677 in 2024 and the lowest number since 1977.

Live births fell across every region in England. The West Midlands recorded the largest percentage decline at 3.1 per cent, while the North East had the smallest at 0.3 per cent.

The average age of parents also increased slightly.

Mothers had a provisional standardised mean age of 31.1 in 2025, compared with 31.0 in 2024. Fathers had an average age of 34.0, up from 33.9.

In 1975, the average age was 26.4 for mothers and 29.5 for fathers.

The proportion of births where the mother was born outside the UK also increased, from 20.8 per cent in 2005 to 27.5 per cent in 2015 and 34.6 per cent in 2025.

India was the most common country of birth for non-UK-born mothers in 2025 for the fourth consecutive year.

It was followed by Pakistan, Nigeria and Romania.

In 2025, 56.4 per cent of births were to parents who were both born in the UK, down from 62.7 per cent in 2015.

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Menopause

Menopause hormone therapy may improve cardiovascular health outcomes, study suggests

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Hormone therapy started in peri- or early post-menopause was linked to a 22 per cent lower risk of cardiovascular events in women with vasomotor symptoms in a recent study.

The findings came from an observational analysis of 20 years of health data and do not show that hormone therapy caused the reduction in cardiovascular risk.

The association was strongest among Black women and women who started treatment within 10 years of menopause onset, although researchers cautioned that the findings should not guide clinical practice.

The study is the first of its kind in the US to assess the risk of future cardiovascular events among women with vasomotor symptoms who use hormone therapy during peri- and early postmenopause.

Samar R. El Khoudary, professor and chair of the Department of Epidemiology at the VCU School of Public Health and one of the study’s senior researchers, said: “The menopause transition represents a critical window for understanding how hormone therapy may relate to cardiovascular disease risk. Our findings suggest that timing of initiation may influence cardiovascular outcomes.”

The researchers stressed that the findings do not support using hormone therapy to prevent cardiovascular disease.

Potential benefits must also be weighed against risks, including the increased breast cancer risk observed with longer-term use.

The study was not a randomised controlled trial, the gold-standard method for testing biomedical treatments.

Rebecca C. Thurston, associate dean for Women’s Health Research at the University of Pittsburgh School of Medicine and one of the study’s senior researchers, said: “These findings point to women with vasomotor symptoms as those who may show cardiovascular benefit from hormone therapy initiated during the perimenopause and postmenopausal years.

“However, conclusions should be tempered by the observational nature of the study, and findings should not guide clinical practice.”

Vasomotor symptoms, meaning hot flushes and night sweats, affect up to 80 per cent of women during the menopause transition and last for an average of seven to ten years.

Their frequency and severity build through perimenopause and typically peak in early postmenopause.

Hormone therapy replaces oestrogen and progesterone that women’s bodies stop producing after menopause and is currently the most effective treatment for these symptoms.

Clinical trials led by the Women’s Health Initiative in the early 2000s raised concerns about hormone therapy’s impact on heart disease, stroke, breast cancer and other risks, leading to years of reluctance among patients and providers to use the treatment.

El Khoudary said: “Hot flashes and night sweats have a significant impact on a woman’s quality of life and ability to work productively.

“While hormone therapy is an effective treatment for these symptoms, questions have remained about its cardiovascular effects, particularly the importance of when treatment is initiated during the menopause transition.”

More recent research suggests the effects of hormone therapy on the heart and vascular system may vary by age and treatment timing, with women younger than 60 who start treatment closer to menopause onset having different levels of risk.

In 2026, the US Food and Drug Administration removed “black box” warnings from hormone therapy products, reflecting evolving evidence on the benefits and risks of treatment.

Researchers from Virginia Commonwealth University and the University of Pittsburgh analysed data from more than 2,700 women taking part in the Study of Women’s Health Across the Nation (SWAN).

The women reported vasomotor symptoms and had not previously experienced cardiovascular events.

Clinical data collected between 1997 and 2017 were used to examine whether women who started hormone therapy for vasomotor symptoms were more or less likely to experience stroke, congestive heart failure, heart attack or revascularisation procedures than women who did not start treatment.

El Khoudary said: “By using data from the SWAN study, we essentially were able to emulate a series of hypothetical clinical trials to gain a deeper understanding into how hormone therapy taken to mitigate vasomotor symptoms during peri- and early postmenopause influences cardiovascular risk over time.

“It allowed us to examine clinically meaningful cardiovascular disease events over long-term follow-up in a population and treatment window that has been challenging to study prospectively.”

Starting hormone therapy during peri- or early postmenopause was associated with an estimated 22 per cent lower risk of cardiovascular disease events.

Women who began hormone therapy within 10 years of menopause onset had an estimated 27 per cent lower risk compared with women who did not start treatment.

Among Black women, starting therapy during peri- or early postmenopause was associated with an estimated 49 per cent lower risk of cardiovascular disease events.

No clear reduction was seen among women who started therapy more than 10 years after menopause onset or among White women and other racial and ethnic groups.

El Khoudary said: “The differences in cardiovascular outcomes by race and ethnicity are notable, particularly because Black women are more likely to experience severe vasomotor symptoms.

“These findings highlight the need to better understand how hormone therapy timing may influence cardiovascular outcomes across diverse populations.”

It remains unclear why cardiovascular risk differed according to when hormone therapy was started, although researchers believe differences in blood vessel health with age may play a role.

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