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Start-up wins FDA breakthrough designation for at-home cervical cancer screening solution
Teal Health aims to make it easier for women to collect cervical cancer screening samples from home
The US healthcare start-up Teal Health has received breakthrough device status from the US Food and Drug Administration (FDA) for its at-home cervical cancer screening solution.
The Teal Wand is a device that aims to help women collect their own vaginal sample for cervical cancer screening from their home or health clinic, without the need for an invasive exam.
FDA breakthrough, which was awarded after reviewing Teal Health’s midpoint clinical trial data, will grant the start-up priority status when it submits its final study data for FDA review.
The programme helps patients have more timely access to medical devices that could provide more effective diagnosis or treatment of life-threatening diseases and for their potential to benefit populations impacted by healthcare disparities.
With one in four US women not up-to-date on their cervical cancer screening, Teal Health says this FDA breakthrough designation is particularly significant in that it is aimed to increase access for people who rarely or never screen or who can’t undergo a standard exam with the speculum by having an option to screen themselves at-home or in more convenient locations.
Kara Egan, co-founder and CEO of Teal Health, said: “I am so grateful to the amazing team at Teal, our hardworking PIs and sites, the supportive participants in our study, and the FDA for recognising the importance of Teal’s solution to help close the women’s cervical cancer screening gap in the US.
“The speed of our study shows that if you design for and engage with women to advance women’s health, you’ll be met with resounding enthusiasm from this group that has been overlooked and under researched for far too long.
“This study and breakthrough designation is an important moment for women’s health.”
Late last year, Teal Health followed its initial study with a nationwide clinical trial, titled SELF-CERV, which included 17 leading health organisations and more than 600 participants.
The research was designed to validate the performance of the Teal Wand and compare results against a clinician collected sample with a speculum and brush.
The study, which completed enrolment for its initial FDA indication this month, received an overwhelming response from women, exceeding initial enrolment goals.
Lead SELF-CERV enroler, Clair Kaplan, director of clinical research and principal investigator at Planned Parenthood of Southern New England, said: “The Teal Wand and self-collection really resonated with our patients and they were excited to be a part of the SELF-CERV trial.
“We saw upwards of an 80 per cent enrolment rate, which more than met our expectations. I am honoured to have been part of the efforts to advance cervical cancer screening and create more options for patients to get the care they need.”
Cervical cancer is preventable and is curable 92 per cent of the time. However, it is the second leading cause of cancer death among women aged 20-39 and incidence is increasing among women aged 30-44.
More than half of cervical cancer cases are in people who are not routinely screened, which is in large part due to barriers such as discomfort during the exam, lack of information, time and access.
Studies show that women of all races and socioeconomic levels experience these barriers, with native American, black and Hispanic women resulting in higher under-screened rates.
Self-collection, which has already been adopted in countries such as Australia, is thought to increase access to screening.
Trena Depel, vice president of clinical and regulatory at Teal Health, said: “FDA’s recognition of the Teal Wand as a breakthrough device acknowledges the important public health benefit that self-collection for cervical cancer screening can have on those who are rarely screened or who do not participate in clinician-based screening for cervical cancer.
“The clinical performance of the Teal Wand shows promise that an at-home self-collection device is possible in the near term and Teal looks forward to working closely with FDA to expedite this option to eligible women and people with a cervix.”
A new Female Health Hub launched by the English FA will support women and girls in grassroots football in England with trusted advice on health issues affecting play.
The hub brings together expert-backed guidance, practical tools and player insights in one place, giving women and girls practical advice and reassurance on female health in football.
It has four core aims: to help women and girls better understand their bodies and how female health affects performance and participation, to educate players on key health topics and when to seek further advice or support, to provide practical strategies to help navigate common female health challenges, and to help break down taboos and normalise conversations around female health in football.
Users of the hub will also be able to hear directly from members of the England women’s national team, who share their own experiences of navigating female health matters while playing at the highest level of the game.
“Our ambition is to create a game where women and girls can thrive,” said Sue Day, the FA’s director of women’s football.
“To achieve that, it’s essential that players feel supported in environments that understand and respond to their female health needs.
“We’ve heard directly from grassroots players that they want better information and support around female health, but that they often don’t know where to find it.
“The launch of the Female Health Hub marks an important step in changing the landscape.
“We want every player to feel confident in her own skin and supported without judgment, so she can feel empowered by her body, rather than held back by it.”
The platform was launched following research conducted by the FA that highlighted the need for better education and support around female health in football.
According to the FA, 88 per cent of adult players surveyed said their menstrual cycle has an impact on their ability to train or play, but 86 per cent reported they had never received education about the menstrual cycle in relation to football performance and training.
The research also found 64 per cent of women experience issues related to sports bras or breast health while playing football, despite sports bras being considered one of the most important pieces of playing kit.
Players also expressed strong interest in learning more about injury prevention, at 87 per cent, nutrition, at 84 per cent, and mental health, at 77 per cent, in relation to female health.
The first phase of the Female Health Hub focuses on three of the most requested topics: menstrual health, breast health and injury resilience, with further content to follow, including nutrition and pelvic health guidance.
The Royal College of Midwives (RCM) has referred to the women’s health strategy as a ‘missed opportunity’ to address maternity services.
The renewed strategy was released by the government this week, with the aim of putting women’s experiences at the centre of care and ensuring they are “better heard and served”.
However, the government stated that because of ongoing investigations into maternity services across the country, the strategy “does not seek to address safety in maternity and neonatal services”.
The RCM described this as a “missed opportunity” and urged the government to ensure that, following the inquiries, maternity is placed “at the very heart” of the strategy.
Gill Walton, RCM chief executive, said the college was “deeply disappointed” that maternity services “do not feature as a headline priority” in the renewed strategy.
She said: “This is a significant missed opportunity and one that is very difficult to understand.
“Pregnancy, birth and the postnatal period are not a footnote in women’s health – they are one of the most significant and consequential phases of a woman’s life.
“A strategy that treats maternity as an afterthought is not truly a women’s health strategy at all. It is exactly the kind of thinking that has allowed maternity services to reach the point they are at today.”
Walton acknowledged that the strategy contained commitments on ensuring women’s voices shape their care, on supporting families through pregnancy loss and on the principle that services should be held accountable when they fail to listen to women.
She added: “But a strategy that addresses one part of women’s health while leaving maternity care behind is only doing half the job.”
Walton urged the government to ensure that this is addressed when the ongoing investigations into maternity care conclude, with any recommendations placed “at the very heart of this strategy with the seriousness and urgency that women, families and midwives deserve”.
In the foreword to the renewed plans, health and social care secretary Wes Streeting referred to the ongoing independent National Maternity and Neonatal Investigation as action being taken by the government to improve safety in maternity services.
The strategy also refers to the new National Maternity and Neonatal Taskforce, chaired by Streeting, which aims to help deliver “safer, more equitable care” for women, babies and families.
The foreword said that, because of ongoing initiatives, it was “important that this work continues without restriction and that the government can properly respond to the findings”.
It added: “This renewed women’s health strategy therefore does not seek to address safety in maternity and neonatal services other than that related to women’s health before and during pregnancy and the actions we are taking immediately to improve maternity and neonatal care.”
The strategy does, however, include plans to prioritise health education in schools, communities and healthcare settings to “empower women” with the “knowledge and tools they need to help control their fertility” and “prepare for the best pregnancy outcomes.
It also promises to provide women with access to “safe and high-quality contraception, abortion care, fertility services, preconception care and support after pregnancy loss in convenient settings.
Article produced in association with London Pregnancy Clinic and Jeen Health
For the majority of couples planning a pregnancy, genetic testing is not something they think about until a problem arises.
Pre-conception genetic carrier screening challenges this approach by identifying risk before pregnancy begins.
As panel sizes have grown and at-home testing options have become widely available, carrier screening is transitioning from a niche clinical referral into a mainstream component of reproductive planning.
What Carrier Screening Tests For
Being a carrier of a genetic condition means carrying one copy of a variant in a gene associated with that condition, without being affected by it.
In most cases, carriers are entirely unaware of their status.
The clinical significance of carrier status emerges when both members of a couple carry a variant in the same gene: in this scenario, each pregnancy carries a one in four chance of resulting in a child who inherits two copies of the variant and is affected by the condition.
The conditions most frequently included in expanded carrier screening panels include cystic fibrosis, spinal muscular atrophy (SMA), fragile X syndrome, sickle cell disease, and a range of metabolic and enzyme deficiency disorders.
The Beacon 787 carrier test, offered by Jeen Health, screens for 787 conditions from a single sample, making it one of the most comprehensive panels currently available to UK families.
Who Is Most Likely to Benefit
Any couple planning a pregnancy can consider carrier screening. It is particularly relevant for:
- Couples with a family history of a known inherited condition
- Those from populations with higher carrier frequencies for specific conditions, including Ashkenazi Jewish, South Asian and African communities
- Couples pursuing fertility treatment, where genetic information informs treatment planning
- Those who wish to have the most complete picture of their reproductive health before conception
Importantly, being a carrier of a condition does not mean a child will be affected. It means there is a defined statistical risk that can be quantified, discussed and planned for with appropriate clinical support.
How the Test Is Performed
Carrier screening is typically carried out on a blood or saliva sample.
For at-home options such as the testing offered by Jeen Health, a cheek swab collection kit is dispatched to the patient, the sample is returned by post, and results are delivered digitally within a defined turnaround period.
In-clinic carrier testing may use a blood draw and provides the advantage of immediate access to a clinical consultation at the point of result delivery.
London Pregnancy Clinic offers genetics counselling through its partnership with Jeen Health, allowing couples to receive and contextualise carrier test results with expert support.
Genetic counselling before and after testing is recommended by Genomics England as a standard component of any genomic testing pathway.
What Happens If Both Partners Are Carriers
If both partners are identified as carriers for the same autosomal recessive condition, they are typically offered further counselling to discuss their options.
These may include proceeding naturally with an awareness of the risk, using prenatal diagnosis (CVS or amniocentesis) during pregnancy to test the fetus, or pursuing preimplantation genetic testing (PGT) in the context of IVF, which allows unaffected embryos to be selected before transfer.
The purpose of identifying carrier status before pregnancy is to give couples time to consider these options without the added pressure of an ongoing pregnancy.
Knowledge of carrier status does not remove reproductive choices; it expands the information available when making them.
The Role of Pre-Conception Services
Carrier screening sits within a broader category of pre-conception care that includes fertility assessments, general health optimisation and, where relevant, management of existing conditions before pregnancy begins.
London Pregnancy Clinic offers pre-conception services encompassing fertility investigations, genetics counselling and carrier testing as part of an integrated 0th trimester approach, allowing couples to address genetic and clinical risk factors before their pregnancy starts rather than after.
Disclaimer: This article is produced for informational purposes only and does not constitute medical advice, diagnosis or treatment.
Clinical guidance referenced reflects published NHS, NICE and RCOG standards as at March 2026. Individual circumstances vary; readers are advised to consult a qualified healthcare professional before acting on any information in this article.
This piece was produced in association with London Pregnancy Clinic and Jeen Health, which provided background clinical information for editorial purposes.
Hyperlinks to external sources are included for reference only and do not represent an endorsement of any product, service or organisation.
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