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Women in US can now collect their own sample for cervical cancer screening
Self-collection has been shown to improve cervical cancer screening access, especially in underserved populations
The US medtech company BD has announced the FDA approval for the use of self-collected vaginal specimens for HPV testing when cervical specimens can’t otherwise be obtained.
The approval is hoped to allow women to self-collect vaginal specimens for HPV testing in a healthcare settings, which could include non-traditional locations, such as a retail pharmacy or mobile clinic.
HPV is the cause of virtually all cervical cancer, and HPV testing is the preferred screening method by the American Cancer Society in the United States.
The BD Onclarity HPV Assay is FDA-approved for HPV primary testing without the need for a traditional smear test performed with a speculum.
This new approval of self-collected samples has the potential to open the door to a less invasive testing option and improve access to testing for individuals who face barriers to cervical cancer screening.
“Many patients are uncomfortable with the intimate nature of a pelvic exam,” said Dr Jeff Andrews, board-certified gynaecologist and vice president of global medical affairs for diagnostic solutions at BD.
“Also, many people live in areas without a local doctor or clinician trained to obtain a sample with a speculum. The option to self-collect in a clinical setting can help women overcome some of these barriers.”
Cervical cancer is preventable, and screening plays a crucial role in early detection and prevention.
According to the American Cancer Society, approximately 50 per cent of cervical cancer diagnoses are in never-screened people, and 10 per cent of diagnoses occurs in under-screened individuals.
In addition, the National Cancer Institute estimates that 25 per cent of women in the US do not receive regular cervical cancer screening.
Various factors contribute to inadequate screening, including physical and geographic inaccessibility, financial insecurity, lack of awareness about the importance of screening, social or religious preferences, physical disability, medical conditions, or history of sexual, physical or psychological abuse that may make a pelvic examination for sample collection traumatising.
Self-collection has been shown to improve cervical cancer screening access, especially in underserved populations.
In the US, black, Hispanic and American Indian women have higher rates of cervical cancer than women of other racial groups, with black women having the highest rate of death.
With vaginal self-collection as an option for cervical cancer screening, women could become more inclined to participate in such care, allowing healthcare providers an alternative option to identify a high-risk HPV infection in more convenient care settings.
Dr Shieva Ghofrany, a practicing OB/GYN and fellow of the American Congress of Obstetricians and Gynecologists, said: “Self-collection provides greater access to testing.
“BD Onclarity allows healthcare providers to determine the specific HPV strains present in the samples and more precisely identify and treat individuals at high-risk and avoid unnecessary treatments for women at low risk.”
The National Cancer Institute (NCI) has been working with BD in a public-private partnership to address disparities in cervical cancer screening.
As part of this initiative, BD will be a participant in the Self-collection of HPV testing to Improve Cervical Cancer Prevention (SHIP) trial, which will begin enrolling this summer, to evaluate accuracy of self-collection for HPV testing both in healthcare and other settings, including at home.
The Femtech World Awards is proud to reveal the shortlist for Research Project of the Year as part of the third annual global celebration of innovation, impact and leadership across women’s health.
From fertility science and perimenopause research to regional ecosystem analysis, the shortlisted projects reflect the breadth and growing influence of femtech research worldwide.
The category is sponsored by OncoGenomX, with the winner to be selected by a representative from the organisation.
OncoGenomX is dedicated to offering solutions and providing comprehensive support services that empower Drug Developers, Clinical Researchers, Oncologists,NextGenSeq Diagnostics Laboratories, NextGenSeq Service Organisations, Cancer Diagnostics and Therapeutics Companies to achieve their ambitious goals
The shortlisted entries for Research Project of the Year are:
Women’s health remains significantly underserved in South-East Asia, with persistent gaps in access, awareness, and quality of care carrying substantial social and economic costs.
This report examines the femtech landscape in Indonesia, the Philippines, Singapore, Thailand, and Vietnam, highlighting market trends, emerging technologies including artificial intelligence, and the evolving support ecosystem.
It identifies key challenges facing femtech founders, including limited access to finance, low awareness and persistent stigma, marketing constraints linked to content moderation, and gaps in tailored ecosystem support.
Led by Stephanie Willson, MD, of the IVI RMA Global Research Alliance, the study explored whether embryos that show certain chromosome abnormalities during genetic testing may still have the potential to result in a healthy pregnancy and live birth.
The research analysed more than 7,600 frozen embryo transfers and found that some embryos previously considered unlikely to succeed were still capable of leading to successful pregnancies, although at lower rates than embryos without abnormalities.
The findings could help fertility clinics and patients make more informed decisions during IVF treatment, particularly in cases where there are limited embryos available.
Rather than automatically discarding these embryos, the research supports a more evidence-based and personalised approach to fertility care.
For many women, perimenopause can feel confusing and unpredictable, with limited research explaining what is happening in their bodies.
Natural Cycles set out to change that by leading one of the largest studies ever conducted on menstrual and ovulatory patterns, uncovering new insights into how ovulation behaves as women approach menopause.
Conducted in collaboration with researchers from George Washington University, Seattle Clinical Research Center, Gennev and the University of California San Diego, the study analysed nearly one million menstrual cycles from more than 197,000 women aged 18–52 across more than 140 countries.
The scale of this dataset made it possible to explore menstrual patterns and ovulation in far greater detail than has traditionally been possible in women’s health research.
The Femtech World Awards celebrates the innovators, researchers and organisations driving meaningful progress in women’s health.
What happens next
Winners across all categories will be revealed during the virtual ceremony on June 19, with winners receiving a trophy and an interview with a Femtech World journalist.
Women over 40 are seeking raves for mental and physical wellbeing, with a study suggesting the benefits go beyond nightlife.
The findings challenge the idea that nightlife and electronic dance music events are mainly for younger people.
Published in Psychology of Music, the study focused on the common misconception that nightlife is only for younger audiences.
Researchers surveyed 136 female clubbers aged 40 to 65 about their experiences at electronic dance music events.
The study, carried out at the University of Leeds in England, found women reported mental and physical wellbeing benefits from attending these events.
Seeing favourite DJs was the most common motivation, but many women also described dancing as a way to relieve stress and find emotional support.
The research found that 65.9 per cent of participants described attending a rave as “spiritual”, while 62.9 per cent said it offered an escape from everyday life.
A further 58.3 per cent said they felt like a different version of themselves in a club environment.
Nine in ten participants said they felt at home at electronic dance music events, with many pointing to a shared passion for music and the sense of community around it.
The study also suggested physical fitness played a role, with some women saying they had made clubbing part of their regular exercise routine.
However, the findings also highlighted challenges for older women in nightlife spaces.
One fifth of participants said they felt visibly out of place because of their age.
Nearly half reported unwanted physical contact, leading some to seek out different venues or attend only with friends.
Osteoporosis may raise the risk of death in postmenopausal women by up to 47 per cent, a new study suggests.
The findings point to an inverse relationship between femoral bone mineral density and mortality risk, especially within certain ranges.
Femoral bone mineral density is the amount of mineral in the thigh bone, which is often measured to assess bone strength and osteoporosis risk.
Dr Monica Christmas is associate medical director for The Menopause Society.
She said: “Osteoporosis often remains a silent threat after menopause, despite its profound effect on women’s lives—from loss of height, poor balance, and reduced mobility to disfigurement, pain, and even premature death.
“Early screening and preventive measures, including a calcium-rich diet (preferably from food sources), regular weight-bearing exercise, and hormone therapy when appropriate, can significantly improve bone health and reduce risks not only of fractures but also cardiovascular disease, certain cancers, and dementia.
“It’s time we bring this conversation to the forefront.”
In the study involving nearly 3,000 postmenopausal women, bone mineral density at four femoral sites was assessed using dual-energy x-ray absorptiometry, a scan commonly used to measure bone strength and fracture risk.
The analysis found that mortality risk was significantly higher when femoral bone mineral density reached the osteoporotic threshold or when osteoporotic fractures were present.
After full adjustment, osteoporosis was associated with a 47 per cent increased risk of mortality.
A stronger inverse association between increased bone mineral density and mortality risk was seen within specific ranges, suggesting bone mineral density could serve as a prognostic marker of wider health.
The relationship appeared especially notable within the range of 0.46 to 0.71 g/cm² for total femur bone mineral density.
Previous research has shown that postmenopausal women face a significantly higher risk of death within one year of hip or vertebral fractures.
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