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The new era of lateral flow technology and its impact on women’s health

By Nina Garrett, chief technical officer at Abingdon Health

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What impact will the explosion in lateral flow technology and adoption have on women’s health? Abingdon Health’s CTO Nina Garrett provides her insights into what the future may hold.

The rise of lateral flow technology has significantly reshaped the landscape of healthcare, particularly for women.

From its origins in pregnancy testing to its current widespread use, lateral flow tests (LFTs) have made health monitoring more accessible and convenient. Here, we explore the history of lateral flow tests, the current rapid self-tests available for women, the reasons behind their adoption, and the potential future applications in women’s health.

The origins of lateral flow technology and pregnancy testing

Lateral flow technology dates back to the 1960s when researchers first began exploring immunoassay techniques for rapid testing. The first commercial lateral flow test, however, came to prominence in the late 1970s and early 1980s with the introduction of the home pregnancy test.

The first lateral flow test: home pregnancy testing

In ancient Egypt, an intriguing method to determine pregnancy involved women urinating on barley and wheat seeds. If the seeds sprouted, it was believed the woman was pregnant.

Surprisingly, modern science supports this ancient practice, as the hCG hormone in a pregnant woman’s urine can indeed promote seed growth. This historical test showcases the ingenuity of early diagnostic methods and the enduring quest for reliable pregnancy tests.

Fast forward to the early 1960s, scientists developed sophisticated techniques to detect hCG in urine. The significant breakthrough came in 1978 when Warner-Chilcott introduced the first over-the-counter home pregnancy test, the “e.p.t” (early pregnancy test).

This innovation transformed women’s health by offering a private, quick and reliable way to confirm pregnancy without needing a doctor’s visit, marking a new era in personal health diagnostics.

While this was a significant breakthrough, the pregnancy testing market remained relatively untouched until Abingdon Health’s recent release of the world’s first saliva pregnancy test which can now be found under the Boots brand to encourage adoption. HcG remains the flagship at-home women’s test but it has paved the way for what we now see on shelves.

Current rapid self-tests available for women

Today, lateral flow technology has expanded far beyond pregnancy tests empowering women to pro-actively manage their own health and wellbeing. Rapid self-tests are available that cater to women’s health needs include:

Ovulation tests: These tests detect the surge in luteinising hormone (LH) that occurs before ovulation, helping women identify their fertile window for conception.

Urinary tract infection (UTI) tests: These tests detect nitrites and leukocytes in urine, indicating the presence of a UTI.

Sexually transmitted infection (STI) tests: Some STI tests can be performed at home, testing for infections like chlamydia and gonorrhoea using urine samples or vaginal swabs.

Vaginal pH tests: These tests help diagnose bacterial vaginosis or yeast infections by detecting abnormal pH levels in vaginal secretions.

Menopause tests: These tests measure follicle-stimulating hormone (FSH) levels in urine, which can indicate the onset of menopause.

Vitamin D deficiency tests: One of the most common deficiencies worldwide, these tests allow the monitoring of deficient and sufficient levels. Vitamin D is essential for healthy bones and teeth, the immune system, brain health and for regulating inflammation.

Ferritin (iron) deficiency tests: Iron is a crucial mineral that plays several vital roles within the body including, oxygen transport, muscle function, enzyme activity and immune function. A lack of iron can result in iron deficiency anaemia.

Why women choose to use rapid self-tests at home

There are some distinct advantages in using rapid tests, however, there still are challenges to consider. We take a look at some of these below.

Advantages

  • Convenience: Rapid self-tests empower women to conduct health checks at their own convenience, eliminating the need for scheduling and attending doctor’s appointments.
  • Privacy: These tests offer a discreet way to monitor health conditions, which is crucial for sensitive issues like pregnancy, sexually transmitted infections (STIs), or menopause.
  • Quick results: Delivering results within minutes to hours, these tests enable timely decision-making and prompt treatment.
  • Cost-effective: Self-tests are generally more affordable than visiting healthcare providers, as they cut out consultation fees and reduce overall healthcare costs.

Disadvantages

  • Accuracy concerns: Despite high accuracy rates, rapid tests can produce false positives or negatives, leading to unnecessary anxiety or false reassurance. This is where a trusted developer and/or supplier of LFTs is critical.
  • Misinterpretation: Users may misinterpret results if instructions are not followed carefully, potentially leading to incorrect health decisions.
  • Limited scope: Designed to detect specific conditions, self-tests do not offer a comprehensive health assessment and might miss other underlying issues.
  • Need for follow-up: Positive results typically necessitate follow-up with a healthcare provider for confirmation and treatment, which can still be inconvenient.
Potential future applications of lateral flow tests in women’s health

The potential for expanding the use of lateral flow technology in women’s health is immense, and as a contract development manufacturing organisation  (CDMO), we are at the forefront of developing some novel products within women’s health and wellbeing. Here are several areas where future rapid self-tests could have a significant impact:

Hormonal imbalances

Hormonal imbalances can lead to a range of health issues, including irregular menstrual cycles, polycystic ovary syndrome (PCOS) and menopause-related symptoms.

Future self-tests could monitor hormone levels such as oestrogen, progesterone and testosterone, enabling women to manage their reproductive health more effectively.

Breast cancer

Early detection of breast cancer is crucial for successful treatment. Researchers are exploring the possibility of developing rapid self-tests that detect biomarkers associated with breast cancer in blood or saliva samples, allowing for regular, non-invasive screening at home.

Endometriosis

Endometriosis is a painful condition where tissue similar to the lining of the uterus grows outside it. Currently, diagnosing endometriosis requires invasive procedures.

Rapid self-tests that detect biomarkers in blood or urine would be a groundbreaking development for early diagnosis and management.

Fertility and menstrual health

In addition to existing ovulation tests, comprehensive fertility tests could assess multiple hormones and health markers to provide a detailed fertility profile. Similarly, tests that track menstrual health and predict issues such as dysmenorrhea (painful periods) or amenorrhea (absence of periods) would be invaluable.

Mental health

Mental health conditions, such as postpartum depression, are often underdiagnosed and undertreated. Innovative approaches to detect stress hormones or other biomarkers related to mental health could provide early warnings and facilitate timely intervention.

Nutritional deficiencies

While there are some rapid tests for detecting deficiencies in vitamins and minerals on the market, such as our iron self-test and vitamin D self-test as set out above, others like B12, could help women manage their dietary intake and address potential issues more proactively.

The explosion in lateral flow technology and its adoption holds immense promise for women’s health. The convenience, privacy and quick results provided by rapid self-tests are transforming how women monitor and manage their health.

While there are limitations to current self-tests, ongoing advancements in this field are going to expand their scope and accuracy, making them even more integral to women’s healthcare.

As research progresses, we can anticipate a future where rapid self-tests become commonplace for diagnosing and monitoring a wide range of conditions. This shift towards at-home testing will empower women to take more control of their health, leading to earlier detection, better management of chronic conditions and overall improved health outcomes.

Abingdon Health’s team has over 20 years’ experience in the lateral flow market and is a knowledge leader in the development, scale-up, transfer, manufacturing, regulatory approval and distribution of lateral flow products across a range of sectors. If you would like to understand more about these services, and discuss any specific requirements, don’t hesitate to contact Abingdon’s experts today.

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From PCOS to thyroid troubles- an exploration of women’s hormones

By Dr Haleema Sheikh, a specialist in integrative women’s health and bioidentical hormone balancing for the Marion Gluck Clinic

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Dr Haleema Sheikh, a specialist in integrative women's health and bioidentical hormone balancing for the Marion Gluck Clinic

Hormones are our bodies’ communication messengers. They are chemicals that are released by one organ/tissue that are carried in the blood and impact another organ/tissue and thus coordinate different functions in our body.

These signals tell your body what to do and when to do it and cause significant issues when there is hormonal imbalance.

Hormonal balance is very often related to our lifestyle. The environment we bathe our genes in impacts which genes are switched on and off.

Our body is always trying to be balanced and so our hormones adapt to try to create balance within the body and are a reflection of environmental and mental inputs.

Unlike men who have a 24hr testosterone cycle with testosterone peaking in the morning, the female menstrual cycle requires a complex dance of hormones to interplay to release an egg monthly.

This includes building up the lining of the womb in preparation for a fertilised egg and if there is no pregnancy to allow the lining to break down and start the whole process again.

This roughly 28-day cycle can be easily unbalanced by a number of factors, including poor nutrition, suboptimal movement, disturbed sleep, excess stress, poor relationships and high toxic burden from environmental toxins.

Reproductive hormonal symptoms can show up in a variety of ways including painful and/or heavy periods, infertility, altered cycle and PMS.

PCOS is a common (one in five to 10 women) but often poorly understood whole body hormonal/metabolic disorder that affects women of reproductive age.

The defining feature of PCOS is irregular/anovulatory cycles and the over-production of male type hormones- androgens. The increased androgens can lead to acne, oily skin and hirsutism.

Many women with PCOS also struggle with weight gain, particularly in the abdominal area.

The irregular cycles can interfere with getting pregnant and so balancing the hormones is key to restoring fertility.

There are genetic predispositions for PCOS which had a survival advantage in the past when food was scarce, and we had to fight predators.

It has been said that women with PCOS have the genes of warrior princesses and this is why it has perpetuated.

Women with this condition are struggling in today’s modern society because we are often sitting at work for hours at a time and then sitting in front of screens in the evening.

Our genes expect movement in the day and to follow natural rhythms and the sedentary nature of modern day life results in a mismatch and health issues.

The name arises from the multiple follicles seen on ultrasound of affected women- these are not true cysts.

Many young women will have these appearances and should not be automatically diagnosed with PCOS unless they have the androgen excess symptoms and irregular periods.

Women suffering from PCOS have hormonal imbalance that has a few root causes including blood sugar regulation (insulin resistance), inflammation and poor gut health. Addressing these areas is foundational to managing and reversing PCOS symptoms.

The conventional medical model is focussed on managing symptoms of PCOS and will often result in putting women on the pill to regulate periods and reduce androgen symptoms, but this is not dealing with the root cause and bringing the body back into balance.

When women have difficulty getting pregnant, they are given drugs to try to induce ovulation or referred for IVF. These are useful options to explore when lifestyle interventions have not been fruitful and should remain a reserve option.

The functional medicine approach to PCOS focuses on:

  1. Optimising diet to improve insulin sensitivity through encouraging low-carb nutrition which helps improve insulin resistance a cornerstone driver of the condition.
  2. Supporting gut health to reduce inflammation which is another key factor. Pre and probiotics can support the gut microbiome which modulate hormone balance and detoxification.
  3. Reducing exposed to toxic ‘endocrine disrupters’ in the environment like BPA in plastics because they’ve been shown to disrupt the hormonal system by altering the way in which hormones interact with their receptors and how they are used/ metabolised within the body. Thesexenoestrogens can be found in plastic bottles/containers and in many skincare products/makeup which get absorbed through the skin so it is important to use ‘clean’ products and work on minimising exposure.
  4. Minimising stress through lifestyle tweaks like meditation and yoga which help support the parasympathetic rest and digest nervous system.
  5. Using targeted supplements and herbs to support hormones further, including magnesium, which improves insulin sensitivity and is anti-inflammatory, omega 3 fatty acids, inositol and zinc.

We can also use natural bioidentical progesterone to help women with PCOS kick start a regular ovulatory cycle.

Progesterone is released in the second half of the cycle after ovulation.

Professor Jerilyn Prior has been a pioneer in her work on the use of cyclical natural progesterone for two weeks on and two weeks off to help trigger ovulation in women who are not ovulating, and this helps correct the hormonal imbalance. This can fully explored in a bioidentical hormone clinic.

Thus, in the example of PCOS we can see the far-reaching, whole-body consequences of reproductive hormone balance.

Interestingly, women are also five to eight times more likely than men to have thyroid hormone problems, with one in eight women developing a thyroid disorder during her lifetime.

The thyroid is a butterfly-shaped gland at the base of the neck that produces hormones (thyroxine) essential for regulating metabolism, body temperature, energy, heart rate, menstrual cycle, mood, and hair and nail growth.

Essentially, it serves as the body’s thermostat controlling how fast things happen in the body by its actions on different organs/tissues.

There are two main categories of thyroid problems hypothyroidism (an under-active thyroid) and hyperthyroidism (an overactive thyroid).

In the case of hypothyroidism, the body literally slows down and causes symptoms like weight gain, brain fog, constipation and sluggishness.

The thyroid is not producing enough of the thyroid hormones – triiodothyronine T3 (active form) orthyroxine T4 or both.

The thyroid is a sentinel gland assessing the environment and ensuring the body adapts appropriately.  It requires a number of nutrients to function optimally and lack of these can cause it to under function. These nutrients include selenium, zinc, vitamin A, iron and iodine.

Reversing these deficiencies can help the thyroid improve its functioning.

In addition, the immune system can become muddled and produce autoantibodies which mark the thyroid for destruction by the white cells of the immune system. This is called Hashimoto’s disease an autoimmune condition which is more common amongst women.

There is a triad of genetic predisposition, increased gut wall permeability which allows the immune system to be more activated and a trigger e.g. stress/gluten exposure which ignites the whole process resulting in the production of antibodies which label the thyroid as foreign and for attack.

The conventional medical model works on trying to reduce the symptoms of hypothyroidism by giving replacement thyroxine support.

This can help the situation but does not address the immune activations and high levels of antibodies causing the thyroid to be attacked. Patients will feel a bit better, but it certainly does not bring vitality and full wellbeing to the majority.

In the functional medicine world patients are often given replacement hormone but there will also be emphasis on addressing the root cause by:

  1. Improving gut health and reducing gut permeability. This requires working on the gut microbiome and nutrition. 85 per cent of patients with Hashimoto’s do better on a gluten-free diet because there is molecular mimicry between the gluten molecule and the thyroid and in individuals with a genetic predisposition the immune system reaction against gluten ingested can also target thyroid tissue.
  2. Working on the other pillars of health sleep, relaxation and movement can also help bring the body back into balance and help the immune activation.
  3. Ensuring there are not nutritional deficiencies impacting the gland.

Women in the perimenopause and menopause are more at risk of thyroid disorders as there are oestrogen receptors on the thyroid and at this time there is hormonal fluctuations which can trigger thyroid dysfunction.

During the menopause, as a result of the lack of estrogen, thyroid function can be suboptimal and this can contribute to the menopausal weight gain around the middle that happens and the deterioration in lipid panels.

We can see how endocrine glands interact with each other; the body has a complex web of interconnection which help keep the body in balance.

When we are seeing hormonal dysfunction symptoms is important not only to look at symptoms control but to look at deeper root causes driving the issues.

Careful consideration to the environment we are bathing our genes is key to optimal hormonal health and this is best done with a medical professional who understands the importance of hormonal health.

To find out more, visit the Marion Gluck Clinic.

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Could femtech tackle period poverty? Here’s what campaigners think

Women’s health campaigners have their say on period poverty after study unveils lack of access to menstrual products

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Period poverty, defined as a lack of access to menstrual products, hygiene facilities and education, affects more than 500 million women and girls globally every month.

While it impacts many on low income, researchers from the University of Southampton have looked at an often-forgotten group: homeless women.

The research, published last month, showed that homeless women experience practical challenges in managing menstruation, alongside feelings of embarrassment and shame, with many “making do” due to inadequate provision.

The review, the first to explore homeless women’s experiences of menstruation, concluded that it’s time to address the provision of menstrual health resources as a basic human right.

Femtech World sat down with charities and women’s health organisations to find out how policymakers and femtech organisations could tackle the issue.

Jennifer Gaines, manager of national engagement at Alliance for Period Supplies

Homeless individuals face unique challenges when it comes to managing their periods, including limited access to period supplies, adequate restroom facilities and stigma associated with managing menstruation.

The femtech industry has a significant role to play in addressing the menstrual needs of the most vulnerable populations, including homeless individuals, and developing unique solutions to the challenges faced, such as lack of access to clean facilities and products.

The industry could address the issue by educating the general public and policymakers, establishing donation initiatives to local organisations that distribute period products to homeless populations and investing in research initiatives to better understand the specific challenges faced by homeless individuals regarding menstruation and the lack of access to period products.

Organisations can also advocate for policy reform on local, state and national levels to address period poverty and homelessness.

In the United States, there are more than 70 million individuals, girls and people who menstruate between the ages of 12 to 44. Of these more than 70 million, one in six lives below the federal poverty line. That means there are millions of people who menstruate in our country who live in poverty and are unable to afford the material basic necessities they need to thrive.

People who live in poverty often face food insecurity, housing insecurity, transportation issues and other struggles every day. Period poverty is yet another obstacle that prevents people who menstruate from reaching their full potential.

Petchara Newson, business development coordinator at the period poverty charity Freedom4Girls

We wholeheartedly agree with the findings of the University of Southampton, which shed light on the urgent issue of period poverty among homeless women. This research reaffirms the observations we’ve made at Freedom4Girls, especially as the period poverty crisis escalates amidst the current recession.

To support homeless women effectively, it’s imperative to ensure they have access to safe and clean spaces where they can use menstrual products. Menstrual hygiene should be prioritised not only in spaces traditionally targeted towards women, like women’s refuges, but also in places where women experiencing poverty exist, such as homeless organisations or food banks.

Increasing representation of menstruators on the boards of diverse organisations and providing training to non-menstruators can help identify gaps in support for menstrual hygiene.

Organisations serving those in poverty should ensure they have clean and safe restrooms equipped with a range of free period products and proper waste disposal facilities.

Furthermore, when supporting homeless menstruators, it’s essential to provide a variety of free period products, including heavier flow options, as many experience heavy periods.

Manjit Gill, founder and CEO of the period charity Binti

In the femtech space, we have some amazing products to manage menstrual health but how much funding is provided for “women’s health?”

Menstrual matters have to include all facets of health which include options of products best suited to the needs of women be it disposable or reusable pads or tampons cups or pants.

The cost of living crisis means people can’t afford food but how many address the unaffordable cost of period products for women?

Period products mandated as essential products in everyday life and menstruation becoming a word that is not shrouded in shame is the only way we can create a world where all women have menstrual dignity.

Terri Harris, education and communication manager at Bloody Good Period

Nearly one and a half million people in the UK can’t currently afford period products, and for those who are unhoused or in unstable accommodation, the additional barriers to accessing and using period products are far worse.

Periods aren’t a luxury, they’re a necessity. Everyone should be able to access period products whenever they need them, for free.

At Bloody Good Period, we’re campaigning for period products to be freely available and accompanied by education, normalisation, and practical support. Without this, we cannot hope to achieve menstrual equity.

Laura Rathbone, founder of Sisters on the Streets

We witness first-hand how the lack of access to menstrual supplies among individuals experiencing homelessness perpetuates a cycle of disadvantage. Without adequate period products, people are not only forced to endure physical discomfort and health risks but also face significant barriers in accessing opportunities crucial for escaping homelessness.

Imagine someone missing out on housing, employment, or education opportunities simply because they bled through their only pair of pants just before a crucial job interview or apartment viewing, rendering them unable to attend.

Addressing menstrual equity is not just about hygiene; it’s about dignity, access to basic rights, and creating pathways to stability and independence for those most vulnerable in our society.

To receive the Femtech World newsletter, sign up here.

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The slippery slope of presumed consent in post-humous reproductive health cases

By Bethany Corbin, healthcare innovation and femtech attorney

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It sounds like something out of a sci-fi film: A young man, on the cusp of starting a family with his wife, suffers a serious accident that renders him brain dead.

His wife, longing for the family they never started, requests access to his post-humous sperm to become pregnant and build the family she was denied.

After a long and arduous battle with the court system, the wife is granted permission to use her dead husband’s sperm to create her family, even though her husband never stated his family-building preferences in a will or otherwise provided consent to the use of his sperm.

If the situation seems fantastical (and a bit scary), beware: This is a true and landmark case that has shifted the consent paradigm for reproductive health on its head in the UK.

While the Human Fertilisation and Embryology Act of 1990 (as amended in 2008) requires written, informed consent to the use of a person’s reproductive materials, the case of Y v A Healthcare NHS Trust [2018] EWCOP18 (affirmed by the Court of Protection in Re X (Catastrophic Injury: Collection and Storage of Sper) [2022] EWCOP 48) departed significantly from this requirement to allow “presumed consent” as an alternative to informed consent.

This trend by the UK courts does not align with the strict letter of the law and is more akin to an opt-out organ donation framework for reproductive health. It begs two questions: (1) What is really in the best interests of a patient who lacks capacity to procreate? (2) Should gametes be treated the same as all other organs?

These are heavy questions that have sparked global debate. On one end of the spectrum, a 2016 article published in the journal Reproductive Biomedicine & Society Online argues that gametes, similar to organs, are resources that should be considered for use after death, given their life-creating properties.

The authors contend that once an individual is dead, they no longer have a meaningful interest in the use of their reproductive material and post-humous conception should follow a framework of presumed consent.

The authors base their argument in large part on studies conducted showing that the majority of men support their partners accessing their sperm for post-humous conception.

On the other end of the spectrum, however, is the fundamental need to protect the best interests of the patient, who is no longer capable of understanding or consenting to the creation of life.

Numerous situations may arise where a partner seeks to exploit a vulnerable individual for their reproductive materials. For example, imagine the situation where a husband has repeatedly said “no” to creating a family. If he then suffers a life-threatening accident, his spouse could claim that he had agreed to start a family and that his consent should be presumed.

The same rationale could apply to an abusive boyfriend seeking to exploit his girlfriend’s reproductive materials and demanding the post-humous harvesting of her eggs to be used in the future. This creates an environment that can easily result in exploitation of incapacitated individuals who do not have the ability to defend their own interests.

The rights and wishes of the deceased must have meaning if we are to respect human autonomy. These individuals are vulnerable, unable to protect their own interests, and at the mercy of others who may try to exploit them.

This becomes particularly concerning when we add in the scenarios of abusive relationships, suicide, and reproductive coercion. If the law does not protect the rights of the vulnerable, who will? In essence, the trending case law prioritises the interests of the living over the rights of the dead.

Presumed consent for post-humous conception is an incredibly slippery slope. Reproductive material is fundamentally different from other organs in that it is not lifesaving, but rather life-creating. If we allow an individual’s partner or family to make their post-humous reproductive choices, where do we draw the line?

In the case of Y v A Healthcare NHS Trust, the court relied on circumstantial evidence to presume the husband’s consent – such as the early fertility treatments undertaken by the husband. But what about cases in which such evidence is fabricated or in which consent has been withdrawn prior to the accident?

The fact of the matter is, there will always be factual permutations and attempts by individuals to manipulate existing legal frameworks to obtain the outcome they want. It won’t always be clear what the deceased wanted or whether the evidence of their desires has been forged.

As a society, our laws have historically protected the most vulnerable. Any decision to depart from this history should be made by a body of elected representatives that can carefully consider the broader ethical implications of this decision and its downstream impacts, not the courts.

Bethany Corbin is a healthcare innovation and femtech attorney on a mission to help thought-leading companies revolutionise women’s health. Through her company, FemInnovation, Corbin partners with emerging companies at the forefront of healthcare transformation to ensure they are building robust, scalable, and legally compliant businesses focused on enhancing health equity. 

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