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Start-up launches clinical trial studying device for cervical cancer

Teal Health aims to reverse the rise of late-stage cervical cancer and get women up to date on their screenings

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Kara Egan, co-founder and CEO of Teal Health

The US women’s health start-up Teal Health has announced a clinical trial for its self-collection device for cervical cancer.

Part of Teal Health’s platform for tackling cervical cancer, the Teal Wand aims to make it easier for women to collect cervical cancer screening samples from home.

According to the developers, the device is designed to increase women’s confidence and adherence to screen for primary HPV and Pap cytology triage and enable conversation and engagement with medical professionals.

The clinical trial, in progress at Johns HopkinsYale UniversityUniversity of ColoradoUniversity of Wisconsin and Washington University, is hoped to support FDA submission and approval of the wand.

Cervical cancer is nearly 100 per cent preventable when caught early yet, more than 12,000 people in the US are being diagnosed and over 4,000 die of the disease each year, disproportionately impacting Black, Asian, and Hispanic women. More than 50 per cent of these diagnoses are later stage and among people who did not have a recent screening.

Discomfort during the exam, lack of information, time and access to gynaecological care are all barriers that have contributed to women not maintaining cervical cancer screenings.

The Teal Wand could potentially help women collect their own vaginal sample from home, without the need for an invasive exam.

“Self-collection is now a viable option thanks to advancements with primary HPV assays, mirroring practices seen in other parts of the world,” said Kara Egan, co-founder and CEO of Teal Health.

“The self-collection approach enables us to revolutionise the screening process and design it for the modern woman. We’re thrilled to have such incredible partners and participants help us execute on this life-saving screening option in the United States, prioritising and respecting a woman’s needs, time, and preferred experience.”

Teal Health’s nationwide clinical study is enrolling participants and comparing results from patient self-collection to a clinician collection using a speculum for the detection of high-risk HPV, which are the strains of the HPV virus that cause more than 90 per cent of cervical cancers.

HPV testing is recommended as the preferred cervical cancer screening method by multiple medical guidelines, including the American Cancer Society.

Dr Christine Conageski, associate professor and OB-GYN at the University of Colorado Anschutz Medical Campus, said: “Through my medical practice as the director of the complex dysplasia clinic, working to increase screening rates is a top concern.

“With national screening rates plateauing or even declining in areas, it requires new approaches to make significant progress. At-home screening options will provide a great alternative to the in-person traditional speculum exam and will increase access and address screening barriers, specifically the need for a more convenient and comfortable experience for women.”

Elizabeth Sutton, principal investigator from the Woman’s Hospital in Baton Rouge, Louisiana, added: “Women in our community experience many barriers when it comes to accessing care.

“What we’ve loved about working with Teal is the excitement by the participants to be a part of the study, and to have their input and experience matter.”

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Diagnosis

Experimental treatment significantly slows progression of fatal brain disease in women, study finds

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Davunetide may significantly slow the progression of a fatal brain disease in women, according to a new analysis of clinical trial data.

The findings indicate that women and men with progressive supranuclear palsy (PSP) may respond differently to the experimental treatment.

Progressive supranuclear palsy, or PSP, is a rare and fatal neurodegenerative disease.

Researchers at Tel Aviv University led the analysis and said the results reinforce the need for sex-specific approaches to neurodegenerative diseases.

Neurodegenerative diseases are conditions in which nerve cells in the brain or nervous system gradually lose function and die.

The team reanalysed data from a 52-week international clinical trial involving more than 300 people with PSP.

The disease is caused by the abnormal accumulation of tau protein in the brain. Tau is a protein found in nerve cells that builds up abnormally in people with PSP.

There is currently no effective drug treatment for the disease.

The work was led by professor Illana Gozes of the Sagol School of Neuroscience and the Gray Faculty of Medical and Health Sciences at Tel Aviv University.

The research team included current and former students Dr Guy Shapira, Jason Blatt and Liri Guz, together with professor Noam Shomron.

The original clinical trial found that Davunetide was safe but ineffective.

However, the researchers separated female and male participants and re-examined the data using updated assessment measures recommended by the FDA.

Women treated with Davunetide experienced a significant slowing of disease progression, while no similar effect was observed in men.

The treatment helped preserve essential movement and functional abilities, including balance, fine motor skills and everyday tasks such as using cutlery, buttoning clothes and washing the face and hands.

Fine motor skills are the small, precise movements needed for tasks involving the fingers and hands.

Treated women also showed significant improvements in language ability, working memory and overall cognitive function.

Cognitive function covers mental abilities such as memory, attention, language and problem-solving.

The analysis also identified profound molecular differences between women and men.

The relationship between levels of pathological tau in cerebrospinal fluid and clinical symptoms was completely reversed between the sexes.

Cerebrospinal fluid is the clear liquid surrounding the brain and spinal cord. A biomarker is a measurable sign that can indicate disease activity.

For example, language abilities declined significantly as tau pathology increased in women, but not in men.

The researchers said this suggests the disease mechanisms may work differently in women and men, potentially explaining their different responses to treatment.

According to professor Gozes, overlooking biological differences between the sexes may hide a genuine treatment effect.

“Our data show that analysing women and men separately is not merely a statistical exercise, but an essential tool for developing more effective treatments for neurodegenerative brain diseases,” she said.

The researchers believe the findings provide a strong scientific basis for future clinical trials and treatment protocols designed from the outset to account for patients’ sex.

These trials could evaluate Davunetide as a targeted treatment for women with PSP.

They said the approach may also pave the way for more precise treatments for tau-related diseases, including Alzheimer’s disease and other neurodegenerative brain disorders.

The study was supported by ExoNavis Therapeutics, which is developing Davunetide for brain diseases under licence from Ramot, Tel Aviv University’s technology transfer company.

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Pregnancy

UK research paves way for new preeclampsia therapies

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A preeclampsia study has found unusual cell activity in mothers and babies that could reveal new targets for treatment.

The condition affects 2 to 4 per cent of pregnancies worldwide and is a leading cause of maternal and foetal mortality.

There is currently no cure, and severe cases can put both the mother and baby at risk.

Scientists from UCL and University College London Hospitals found that stressed placental cells, poorly functioning blood vessels and an overactive immune response all contribute to the condition.

Preeclampsia causes high blood pressure during pregnancy. It can affect blood flow to the baby and cause symptoms such as swelling, headaches, blurred vision and pain under the ribs.

Without treatment, it can damage the mother’s health, slow the baby’s growth and, in severe cases, become life-threatening.

Previous research has focused only on the placenta, the organ that develops during pregnancy to support the baby’s growth, rather than the tissues around it.

The researchers said the findings could reveal new therapeutic targets, which are biological processes that future treatments could be designed to alter.

Senior author professor Sara Hillman, of the UCL EGA Institute for Women’s Health, said: “We studied individual cells from both the mother and the baby to see how their activity changes in healthy pregnancies compared with preeclampsia.

“This helped us to confirm some changes already suspected in the condition and also discover new ones.”

The team studied 20 pregnant women recruited at UCLH, including 10 with severe preeclampsia and 10 without the condition.

They used genomic testing to examine individual cells in the placenta and other tissues where cells from the developing baby and mother come into contact.

Genomic testing examines genetic information to help researchers understand how cells behave and the roles they may play.

The other tissues studied were the myometrium, the muscular layer of the womb, and the chorioamniotic membranes, which surround the baby during pregnancy.

The team compared cells from healthy pregnancies and those affected by preeclampsia at different gestational ages, meaning different stages of pregnancy.

They used technology that can read the genetic information of thousands of individual cells at the same time, allowing them to see what each cell was doing and where it was located in the tissue.

In preeclamptic pregnancies where babies were born prematurely, before 37 weeks, during the third trimester, placental cells showed signs of stress and low oxygen levels.

The cells also did not use energy in the normal way.

Some cells responsible for reshaping the mother’s blood vessels were not working properly, the researchers found, which may affect blood flow to the baby.

There were also signs of an overactive immune response in the placenta, nearby tissues and the mother’s blood.

The researchers said this response, together with other stress molecules released by the placenta, helps explain why preeclampsia affects the whole body and can become serious.

They hope the findings will help researchers find treatments for the condition and potentially save lives.

Co-lead author Dr Yara Sanchez Corrales, of the UCL Great Ormond Street Institute of Child Health, said: “These findings point to specific biological processes that could be targeted with treatments. Acting early in pregnancy, especially in more severe early-onset cases, could help improve outcomes and reduce the high risks associated with severe preeclampsia.

“We hope that our findings may set us on the path to reducing premature births and fatalities associated with preeclampsia.”

Co-lead author Mr Theodoros Xenakis, of the UCL Great Ormond Street Institute of Child Health, said: “Future studies may provide an even clearer picture of the biological changes linked to the disease by including more participants and using even more precise methods.”

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News

Planetary Health Diet lowers heart risk in older women, study finds

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A 20-year study of 66,892 postmenopausal women linked the Planetary Health Diet to lower cardiovascular disease risk.

Women whose eating habits most closely followed the diet had around a 28 per cent lower risk of cardiovascular disease than those in the lowest-adherence group.

Even moderate adherence to the diet was linked with a lower risk.

Donya Shahamati is a doctoral student in public health at the University of California, Irvine.

The researcher said: “Our results suggest that people may not need to follow a perfect or very restrictive diet to see potential heart-health benefits.

“This is especially important for postmenopausal women, because cardiovascular risk increases with age and tends to rise after menopause.”

The diet emphasises fruit, vegetables, whole grains, legumes, nuts and unsaturated fats, while limiting red and processed meats, added sugars, refined grains and saturated fats.

Postmenopausal women are those who have gone through menopause, when periods stop and hormone levels change.

Cardiovascular risk tends to increase with age and rise after menopause.

“Moving towards a more plant-forward, higher-quality diet can be accomplished through small, realistic changes,” said Shahamati.

“These changes might include filling half the plate with vegetables more often; using avocado or olive oil in place of butter; choosing oatmeal or whole-grain cereal for breakfast; or trying a meatless meal once per week.”

For the research, investigators followed 66,892 participants in the Women’s Health Initiative, a long-term national health study funded by the National Heart, Lung and Blood Institute at the National Institutes of Health.

All the women included in the analysis were free from cardiovascular disease at the start of the study, between 1994 and 1998, and had complete information about their diet and other important health and lifestyle factors.

Researchers used information collected through a food frequency questionnaire at the start of the study to calculate a Planetary Health Diet Index score for each participant. Higher scores indicated that a participant’s diet was more closely aligned with the Planetary Health Diet.

They then divided the women into five groups according to how closely their diets followed it.

The women were around 63 years old at the start of the study and were followed for about 20 years to see who developed cardiovascular disease.

When analysing the data, researchers adjusted for factors that could affect cardiovascular risk, including age, race and ethnicity, education, income, smoking, alcohol intake, physical activity, body mass index and total calorie intake.

“We did not only look at overall cardiovascular disease,” said Shahamati.

“We also looked separately at coronary heart disease, stroke and heart failure. This helped us see whether the pattern was similar across different types of cardiovascular outcomes.”

Overall, women whose diets were most closely aligned with the Planetary Health Diet had the lowest risk of cardiovascular disease.

They also had a lower risk of coronary heart disease, heart failure and stroke than women in the lowest-adherence group.

Moderate adherence was also associated with a lower risk, with each 10-point increase in the Planetary Health Diet Index score linked to a further reduction.

The researchers cautioned that, because the study was observational, it could not show that the diet directly caused the lower risk among women.

Observational studies identify links between factors such as diet and disease risk, but cannot prove that one caused the other.

The research team is now exploring other aspects of diet and health among older adults, including how diet quality changes over time.

The researchers said this information could help support healthy ageing and prevent chronic diseases.

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