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Clue launches initiative to close diagnosis gap for female health conditions

The project is supported by top researchers and aims to leverage Clue’s data for new insights

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Audrey Tsang, CEO of Clue

The period tracking app Clue has announced a new initiative to leverage its collective, anonymised health data to help close the diagnosis gap for the most common yet under-researched and underdiagnosed female health conditions.

With the new My Health Record feature within the Clue app, users will be able to input confirmed diagnoses for 21 different health conditions including endometriosis, polycystic ovary syndrome (PCOS), premenstrual dysphoric disorder (PMDD), uterine fibroids, bleeding disorders and anxiety disorders.

Clue is engaging with researchers from top institutions, such as the University of California, Berkeley, and the University of Exeter, and collaborating with the Menarche Menstruation Menopause and Mental Health (4M) consortium on the ways in which this unique dataset can be leveraged to help close the diagnosis gap in areas that have previously lacked large-scale data for research.

Launched in 2021, 4M facilitates collaborative interdisciplinary research into how menstruation and menopause interact with mental health.

Research projects planned for Clue’s Health Record data in 2024 include improving diagnostics for endometriosis and PMDD, exploring the impact of the menstrual cycle on ADHD, anxiety, and depression and shedding light on under-researched symptom patterns in early perimenopause.

“Together with our global user community, we are creating what will be the world’s largest data set that can match the menstrual and wider health symptom patterns of people with confirmed diagnoses with those who have the same patterns, but who don’t yet have a diagnosis,” said Audrey Tsang, Clue CEO.

“By working with top researchers from around the world to leverage this data, we believe we will be able to make significant progress to accelerate and improve diagnostics and support for people with these conditions.”

Gemma Sharp, associate professor in epidemiology in the School of Psychology at the University of Exeter, and founder and director of the 4M consortium, said: “I started the global 4M research consortium because I was astounded by the social stigma, lack of understanding and paucity of research in the field of women’s menstrual health, which is a big contributor to gender inequality. Half the world menstruates, and related health issues can have a major impact on quality of life, health and wellbeing.

 “Now, this new partnership between our global research consortium and Clue is a really exciting opportunity to conduct research at the intersection of two crucial areas: menstrual and mental health.

“This collaboration will allow us to gather and analyse data on a massive scale, enabling us to generate answers which will improve understanding of women’s health, and ultimately improve lives.”

Professor Kim Harley, associate professor at the University of California, Berkeley, said: “The impacts of perimenopause symptoms, including loss of sleep, hot flashes, mood and mental health changes, are coming to the fore as a major factor in economic and health equality.

“However, there is still a lot we don’t know about the very earliest stages of perimenopause, the frequency and severity of symptoms, and individual factors that increase symptoms. This is tied to the lack of real-time data on large populations of people experiencing this highly individual and often gradual process.

“Working with Clue and its new ‘perimenopause mode’ provides the opportunity to study and understand the perimenopausal process. Clue’s data is unique in that it covers poorly understood periods of people’s reproductive lives, including the transition from fertility to menopause, early onset menopause and the experiences of people at the beginning stages of this process before they would otherwise be clinically identified.

“Many people experience symptoms without understanding them as part of the perimenopause process and few people successfully receive clinical support for their symptoms. We hope that our research with Clue will help individual users understand more about this universal life stage.”

Currently, only one per cent of traditional biopharma R&D funding goes into female health conditions, despite women spending nearly twice as much on healthcare as men.

Conditions that disproportionately affect women, such as endometriosis, migraine and anxiety disorders, all attract much less funding relative to the disease burden, which considers the impact on the population in terms of quality of life, cost of care, and loss of productivity.

“What is politely called ‘the research gap’ is more of a research ‘canyon’ when it comes to female health, with the direct consequence that millions of women and people with cycles people are living with symptoms that could benefit from medical support, but too often it takes far too long for them to access that support and treatment,” explained Tsang, Clue CEO.

“We believe through this initiative we’ll be able to uncover insights and patterns that can be used to develop personalised insights to help people engage with their healthcare providers and accelerate the diagnosis process.”

She added: “We know data is power and agency when it comes to health and that it can play a critical role in making what is otherwise invisible, both visible and quantifiable.

“We’re excited to take the scale of Clue data and put it to work to specifically address the diagnosis gaps that cause so much frustration, confusion and pain. Having a diagnosis can mean validation, relief and most importantly, the opportunity to get the help and treatment one needs.”

To paint a picture of the current diagnosis gaps and delays for women and people with cycles:

  • In 72 per cent of cases, women will wait longer than men to get a diagnosis for the same health conditions.
  • One in 10 will have endometriosis, but only 40 per cent will be diagnosed, with seven to 12 years between the first onset of symptoms to the actual diagnosis.
  • 90 per cent of women with PMDD are undiagnosed, with an average delay of 20 years before it is correctly identified.
  • 70 per cent of women with PCOS are undiagnosed and for a third of those with the condition, it will take two years to diagnose. Almost half of people with this condition had to see more than three healthcare providers to get a diagnosis.
  • One in three women with perimenopausal symptoms go undiagnosed  and middle-aged women are more likely to have their symptoms brushed off as mental health related.

As a Germany-based company, Clue says it adheres to the world’s strictest data privacy laws. Data tracked within the app, the company says, has long contributed to important scientific research helping to close the gender-data gap, to improve societal understanding of menstrual and reproductive health.

According to Clue, data is only used for research with the express consent of users – and research partners only work with anonymous data that cannot be traced back to any individual.

In a recent survey, 85 per cent of Clue users indicated that they wanted their anonymised data to be used for health research.

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Femtech must acknowledge the risk of perpetuating medical racism, say campaigners

Campaigners have warned that health tools could overlook women from marginalised communities

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Femtech must acknowledge the risk of perpetuating medical racism, campaigners have warned, amid concern that the sector could perpetuate long-standing racial inequities.

Femtech is already showing promise to help clinicians make better diagnoses and support women with managing their health.

But as excitement grows, campaigners have warned that these powerful tools could overlook women from marginalised communities and perpetuate long-standing racial inequities in how care is delivered.

“Any technology meant to help people track and improve women’s health outcomes must be inclusive and anti-racist,” Dr Regina Davis Moss, president and CEO of In Our Own Voice, told Femtech World.

“Black women have historically been disregarded, overlooked and undermined by the medical technology industry. It is past time for our interests and needs to be prioritised in clinical trials and other forms of scientific research.

“Femtech companies must ensure that their research and clinical trials equitably involve communities of all backgrounds.”

Around 2,000 femtech companies and apps have sprung up in the last decade to address women’s needs, including tracking apps, fertility solutions and menopause platforms.

These new tools are often built using machine learning, a subset of AI where algorithms are trained to find patterns in large data sets like billing information and test results.

The data these algorithms are built on, however, often reflect inequities and bias that have long plagued the healthcare system. Research shows clinicians often provide different care to white patients and patients of colour. Those differences in how patients are treated get immortalised in data, which are then used to train algorithms.

“When our research omits subsets of the population, the accuracy and potential benefits of that research do not extend to those who disproportionately bear the burden of disease,” said Dr Monique Gary, breast surgical oncologist at Grand View Health.

“We are seeing already how AI can harm marginalised communities, where biased algorithms require racial or ethnic minorities to be considerably ‘more ill’ than their white counterparts to receive the same diagnosis, treatment, or resource. This is perilous and avoidable.”

To create responsible and equitable technologies that include BIPOC (Black, Indigenous, and people of colour) women, Gary said companies could start identifying and recruiting experts of colour, via pipeline programmes and incubators.

“We need to start listening to, believing and supporting the voices of Black women,” she said.

“In 2024, women of all ages and races, ethnicities and orientations are telling us out loud what they need to actualise a better version of healthcare which incorporates significant tech utilisation. It’s now up to us to listen.”

Ashley Jones, creative director of Tones of Melanin, said femtech must acknowledge the risk of perpetuating medical racism and prioritise inclusivity.

“Companies in femtech should actively seek out diverse perspectives and experiences, particularly from BIPOC women, in both their datasets and research.

“This includes collaborating with BIPOC brands, stakeholders and organisations to ensure that their products address the specific needs and concerns of BIPOC women.”

Tech developers, Jones said, could address racism by implementing robust diversity and inclusion initiatives within their teams, actively seeking out BIPOC voices in decision-making processes and educating themselves on the unique experiences of BIPOC women in healthcare.

Sylvia Kang, co-founder and CEO at Mira, pointed out that femtech companies should also focus on affordability, as cost can be preventing women from marginalised communities from accessing healthcare.

“Most of the people that can access femtech tools for their health are white mid-to-high income women,” Kang explained.

“Unfortunately, there are some communities, including BIPOC that do not have enough resources to purchase these tools.

“I believe it’s our responsibility to take action and democratise our data and tools in specific ways.”

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US start-up raises US$4.3m to address maternal mental health

The funding is hoped to help FamilyWell scale throughout New England and expand nationally

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The US mental health start-up FamilyWell Health has raised US$4.3m in seed financing to support women facing maternal mental health challenges.

FamilyWell Health is a behavioural health company that integrates specialised mental health services, such as coaching, therapy and psychiatry, into OB/GYN practices.

The platform aims to provide pregnant and postpartum patients with specialised support for depression, anxiety and other perinatal mental health concerns.

New mothers face dire maternal mental health challenges in the US, with a staggering one in seven women suffering from postpartum depression.

Individuals who seek treatment typically wait for months to be seen by a mental health provider and instead turn to their obstetricians, who are often hesitant to screen for mental health conditions knowing there is a shortage of therapists and psychiatrists.

“I had difficulty finding support when I experienced postpartum depression and have cared for countless new moms struggling to access mental health care during one of the most vulnerable periods of their lives,” said Dr Jessica Gaulton, founder and CEO of FamilyWell.

“My experience, both as a survivor and as a practicing neonatologist, inspired me to start FamilyWell to provide equitable, affordable, and accessible mental healthcare for new mothers.”

By partnering with OB providers, Gaulton said FamilyWell would increase access to mental health support for pregnant and postpartum individuals where and when they need it.

The funding, led by .406 Ventures with participation from GreyMatter Capital and Mother Ventures, is hoped to help the start-up scale throughout New England and expand nationally.

Payal Divakaran, partner at .406 Ventures, said: “Given our team’s deep experience backing innovative behavioural health and women’s health companies, we had been looking at this intersection for quite some time.

“FamilyWell offers an elegant solution that is a win-win for all stakeholders, including obstetric practices. Dr Gaulton and her team have built an incredible, mission-driven company poised to address a critical need in women’s mental health.”

Dr Melissa Sherman, medical director and obstetrician at Essex OB/GYN Associates, a FamilyWell customer, added: “When you’re pregnant or caring for a newborn, you can’t afford to wait months for help.

“With FamilyWell, patients get help within days and have ongoing support through one of the biggest transitions of their lives.”

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‘Women crave the quick fix of a silver bullet’: menopause experts have their say on talking therapies

Talking therapies could reduce symptoms that may not be otherwise relieved through HRT, specialists have argued

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The recent research showing talking therapies could help women through menopause is a “fantastic step forward” in the advocation of choice, experts have said, warning that HRT alone will not reduce all symptoms.

Talking therapies, such as mindfulness and cognitive behavioural therapy, have been found to effectively treat menopause symptoms, such as low mood and anxiety.

Researchers from University College London have shown that the practices, which focus on developing behavioural patterns, coping strategies and relaxation techniques, could have benefits beyond those of HRT, including improved sleep, memory and concentration.

The techniques, experts told Femtech World, could help dampen down women’s physiological system, reducing symptoms that may not be otherwise relieved through HRT.

“Our ability to regulate the stress hormone is hampered during menopause, meaning we sit further up the stress scale than we did before,” said Dr Bev Taylor, psychologist and menopause educator.

“Stress also makes many menopausal symptoms worse, either in frequency or severity. These techniques reduce symptoms by dampening down our physiological system and bringing us back down the stress scale.”

The beauty of them, Taylor said, is that they can be used by anyone.

“Whether you can or want to take HRT or whether you want to use them alongside treatments like HRT, you can. This research is a fantastic step forward in the advocation of choice.”

Catherine Harland, menopause educator, coach and founder member of MenoClarity, said talking therapies had received a lot of backlash since the UK’s National Institute for Health and Care Excellence (NICE) recommended them in their updated guidelines.

“Whilst I understand how life-changing talking therapies can be, I fully appreciate why so many women crave the ‘quick fix of a silver bullet’ in the form of HRT as we have been taught this from a young age,” she said. “We have been taught to turn to pharmaceuticals for any symptoms we experience.”

Modern women, Harland said, live stressful, fast-paced lives, juggling a multitude of things and often feel too busy to fit talking therapies into the mix.

“Menopause is a highly sensitive time and it’s vital women begin to understand the importance of self-care which includes talking therapies and mindfulness.

“HRT alone will not reduce symptoms of stress, trauma and metabolic disease caused by living in a high cortisol state for long periods of time.”

Around 15 per cent of women aged 45 to 64 in England are currently prescribed HRT, which has increased rapidly in the last two years from around 11 per cent and continues to increase.

The main benefit of HRT, according to the NHS website, is that it can help relieve most menopause and perimenopause symptoms, including hot flushes, brain fog, joint pains, mood swings and vaginal dryness.

Draft NHS guidelines recommend offering cognitive behavioural therapy, alongside or instead of HRT.

Dr Shahzadi Harper, menopause specialist and founder of The Harper Clinic, said talking therapies could benefit women experiencing menopause symptoms and help them feel more in control. However, she said they should not be it at the forefront of the menopause conversation.

Dr Shahzadi Harper, menopause specialist and founder of The Harper Clinic

“Talking therapies do not address the inherent hormone deficiency that arises due to perimenopause and menopause and the long-term consequences of declining hormone levels,” Harper explained.

“I don’t think they should be at the forefront and definitely not instead of HRT. However, I do think they could be a useful tool, especially as the symptoms of menopause can be quite debilitating and affect mental health and mood.”

Dr Clare Spencer, menopause specialist, GP and co-founder of My Menopause Centre, said while HRT could help many women manage symptoms of the menopause, there would be some women who may continue to experience symptoms, such as poor sleep, low mood and anxiety, despite being on it.

“Women may face other difficulties at the time of the menopause that may be additional causes of stress which can also impact on experience of symptoms of the menopause.

Dr Clare Spencer, GP, menopause specialist and co-founder of My Menopause Centre

“In these cases, there is a place for talking therapies, such as cognitive behavioural therapy and mindfulness, to help break some of the vicious cycles that can then exist.

“There is also a role for talking therapies in helping women who have been advised not to take HRT or do not wish to.”

She said, however, that long NHS waiting lists could prevent women from getting the support they need.

“There is an issue with access to cognitive behavioural therapy and mindfulness-based therapies through the NHS which does need resolving to allow more women access timely support,” she added.

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