Connect with us

Hormonal health

FDA approves menstrual blood diagnostic device in Thailand

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

Published

on

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

IBSA UK launches non-hormonal injectable for menopause symptoms

Published

on

IBSA UK has introduced Hyaluxelle, a non-hormonal menopause treatment for vulvo-vaginal atrophy, easing vaginal dryness and pain during intercourse.

Hyaluxelle is given as deep intradermal injections to the vulvar vestibule, the area at the vaginal opening, in two sessions one month apart, followed by clinical reassessment.

IBSA UK is the UK subsidiary of Swiss pharmaceutical company IBSA.

Vulvo-vaginal atrophy is a key feature of genitourinary syndrome of menopause, a long-term condition caused by low oestrogen that affects genital, urinary and sexual health.

At least half of post-menopausal women are affected, yet many do not seek help, often assuming symptoms are part of ageing.

The condition stems from thinning and drying of vaginal and vulval tissues linked to low oestrogen, leading to symptoms such as dryness, discomfort, altered pH and pain during intercourse.

Hyaluxelle combines high and low molecular weight hyaluronic acid, a moisture-retaining substance found naturally in the body.

The company says this creates a lower-viscosity injection at what it describes as the highest concentration available in the UK, supporting tissue hydration, firmness and elasticity.

The formulation is said to rehydrate the vulvar vestibule and create conditions for restoring tissue structure through collagen and elastin production.

Clinical studies indicate Hyaluxelle improves several vulvo-vaginal symptoms, including reductions in discomfort and pain during intercourse.

Studies also report gains in sexual function domains and a positive trend in some aspects of health-related quality of life.

Histological analyses suggest increased epithelial thickness, enhanced tissue regeneration and reduced inflammatory infiltration after the procedure. In studies, the treatment was well tolerated with no reported major complications.

Joanna, a 59-year-old woman living with severe symptoms, described the personal impact of delayed diagnosis.

She said: “I lived for years with pain, UTIs, cystitis and a loss of sensation, but every visit to my GP, even a female GP, was treated as a bladder issue.

“Nobody suggested it might be linked to the menopause or joined the dots, and none of the treatments I was given helped. Without the right information or support, I became desperate for answers.

“The symptoms affected everything, what I wore, how I exercised, how I slept, but the hardest part was the impact on intimacy with my husband.

“I withdrew from our relationship because I was scared sex would hurt, and the loss of closeness was devastating, and I no longer felt like myself.

“Women deserve clear explanations and real options when their symptoms are not getting better.”

IBSA says Hyaluxelle offers clinicians an option for women whose symptoms persist despite first-line therapies, or for those who cannot receive or choose not to receive hormonal treatments.

Continue Reading

Menopause

Flo Health and Mayo Clinic publish global perimenopause awareness study

Published

on

The US ranks sixth for perimenopause knowledge, behind the UK, Ireland, Canada, Australia and the Netherlands, research by the Mayo Clinic and period tracker Flo has revealed.

Perimenopause is the transition leading up to a woman’s last menstrual cycle and includes the 12 months afterwards, after which menopause is established as hormone levels change.

It typically happens in the mid-40s and lasts an average of six years, though symptoms may start in the 30s.

The study surveyed more than 17,000 women aged 18 and over across 158 countries about their knowledge of perimenopause symptoms.

The US ranked sixth overall, despite growing public discussion of menopause linked to celebrity advocacy and new workplace policies.

Participants most often recognised common symptoms such as hot flushes (71 per cent), sleep problems (68 per cent) and weight gain (65 per cent).

Broader symptoms, including fatigue, irritability and digestive changes, were far less likely to be identified as part of the perimenopause transition.

Among women aged 35 and over who reported being in perimenopause, the five most common symptoms were physical and mental exhaustion (95 per cent), fatigue (93 per cent), irritability (91 per cent), sleep problems (89 per cent) and depressive mood (88 per cent).

Dr Anna Klepchukova, chief medical officer at Flo, said: “We need to normalise conversations around perimenopause and menopause, so women feel empowered to have honest conversations with their doctors and other support systems.

“This study demonstrates a prolonged commitment from both Flo Health and Mayo Clinic in helping women better understand their bodies and advocating for their health through perimenopause, and every other phase of their health journeys, through medically-backed insights and advice.”

International differences

Perimenopause knowledge scores were highest in higher-income countries such as the UK, Ireland and Australia.

Lower scores emerged in Nigeria, France and parts of Latin America.

Digestive issues ranked among the top three reported symptoms in Nigeria, South Africa, India, France, Ireland and several Latin American countries, while mood symptoms such as depressive mood and anxiety ranked among the top three in Germany, Spain, Venezuela, the Netherlands and India.

Dr Mary Hedges, principal investigator at Mayo Clinic, said: “There is a mismatch in knowledge and expectations of perimenopause and actual symptoms experienced during perimenopause.

Many women in perimenopause may not yet be experiencing hot flashes, and are more likely to be experiencing the cognitive and physical symptoms of fatigue, exhaustion, mood, sleep, or even digestive changes.

“The findings from this study illustrate the need to advance perimenopause research and education, so that we can equip both patients and healthcare clinicians with the knowledge and skills needed to address symptoms and improve the quality of care we provide to women.”

The survey ran from 6 December 2024 to 16 May 2025.

Continue Reading

Menopause

Study offers hope to women suffering menopause hot flushes and night sweats

Published

on

A woman’s insulin levels in midlife are linked to when menopausal hot flushes begin and how long they last, new research suggests.

The study found that higher insulin levels at age 47 predicted younger onsets of hot flushes and night sweats, as well as longer durations of these symptoms.

Researchers drew on data from a US study that followed women from a pre- or perimenopausal baseline over 10 years.

Using metabolic measurements collected from participants at age 47, they tested how metabolic traits at this point related to physiological features of the menopausal transition.

Faria Athar, lead author of the study, said: “Higher insulin at age 47 was also associated with longer durations of hot flushes and cold sweats, and a rise in testosterone levels across the menopausal transition.”

Hot flushes, night sweats and cold sweats, collectively known as vasomotor symptoms, affect around 75 per cent of women during the menopausal transition.

Vasomotor refers to the narrowing and widening of blood vessels, which causes these sudden temperature changes.

These symptoms can appear two years before a woman’s final period and persist for as long as 10 years beyond it.

They do not affect all women equally, with age of onset, severity and duration varying considerably. Prior research shows factors such as race, ethnicity and socioeconomic status play a role.

Nicole Templeman, assistant professor of biology at the University of Victoria, said: “Given that insulin may be elevated in the early stages of metabolic disorders, we decided to investigate whether insulin levels prior to menopause might inform the incidence and severity of menopause symptoms.”

The researchers found that insulin levels and body mass index at 47 were both predictors of vasomotor symptom timing and duration.

The strongest statistical association was between higher insulin or BMI and a younger onset of hot flushes.

The analyses showed insulin may be a stronger predictor of hot flushes when taking other metabolic variables into account, while BMI appeared more closely linked to changes in oestrogen levels.

Athar said: “These findings help us to fill some of the gaps in our understanding of menopause symptoms and why their severity varies for different women.”

Continue Reading

Trending

Copyright © 2025 Aspect Health Media Ltd. All Rights Reserved.