The microscopic bacteria living in women’s bodies could be a powerful tool for personalised, non-invasive treatment and earlier diagnosis, according to a new review co-authored by Britain’s Medicines and Healthcare products Regulatory Agency.
The study concludes that the vaginal microbiome is a largely overlooked area of medicine that could dramatically improve outcomes for millions of women.
Vaginal microbiome testing has the potential to revolutionise women’s health by enabling earlier, more accurate, and more personalised diagnosis and treatment of a wide range of conditions – such as common infections, infertility and even cancer, the review authors said.
The MHRA worked with researchers at Kings College Hospital London, the University of Liverpool, Ewha Women’s University and Biowave W Seoul to explore the significant potential of vaginal microbiome diagnostics to revolutionise how we detect, treat and manage a wide range of women’s health conditions – including infertility, miscarriage, preterm birth, gynaecological cancers and menopause-related complications.
While the gut microbiome has received widespread attention over the past decade, research into the vaginal microbiome has lagged far behind.
Nevertheless, this dynamic ecosystem of bacteria plays a critical role in supporting reproductive health and protecting against infection throughout a woman’s life.
Dr Chrysi Sergaki, head of microbiome at the MHRA, said: “We are only beginning to understand how powerful the vaginal microbiome could be as a diagnostic tool. This review sets out the case for making this a major focus of women’s health research and development going forward.”
A case for change
Currently, many diagnostic tools in women’s health are imprecise or subjective, leading to delays in diagnosis, preventative measures and treatment of diseases.
The paper highlights how microbiome-based diagnostics could offer faster, more accurate, and personalised options to detect conditions like bacterial vaginosis (a common vaginal condition caused by an imbalance in the types of bacteria present in the vagina), sexually transmitted infections (STIs), endometriosis (a condition where tissue similar to the lining of the uterus (endometrium) grows outside the uterus, often in the pelvic area), and even fertility and pregnancy complications, including preterm birth).
The review also highlights the historic underrepresentation of women in clinical research, a gap that has contributed to critical shortcomings in our understanding of female-specific conditions.
For example, a study shows that 86 randomised controlled trials in nine journals show that women account for only 37% of participants in many clinical trials, limiting the ability to fully assess how treatments perform in female patients, including their effectiveness and potential side effects.
A recent analysis of the current clinical trial landscape in the UK showed that male-only trials (6.1%) were nearly twice as common as female-only studies (3.7%). Pregnant and breastfeeding women were represented in 1.1% and 0.6% of trials, respectively, which could impact treatment suitability for these groups.
The MHRA’s role in supporting microbiome-based testing
The MHRA is supporting scientists and companies in developing innovative microbiome-based tests, helping to accelerate growth in this emerging field.
It is creating clearer guidance for microbiome tests, and working to provide clearer guidance for companies developing microbiome-related tests, preventative measures and treatment, which helps innovators understand the rules early on and accelerate the approval of products that meet higher safety standards.
It is also developing physical standards to accurately standardise current methods in studying the microbiome, to ensure reproducibility and comparability of studies within and between establishments.
It has also developed materials to help trial a fast DNA test in some London hospitals that can identify bacteria and their resistance to antibiotics within 48 hours – instead of waiting weeks.
The MHRA is making it easier and safer to bring microbiome-based tests into real-world healthcare, making the rules clearer, improving test accuracy, speeding up reviews, and supporting National Health Service (NHS) trials.
What needs to happen next
To make further progress on making the life-saving diagnostic potential of the vaginal microbiome an everyday reality, the authors call for:
• Increased investment in women’s health research;
• Standardised microbiome testing methods;
• Wider inclusion of women in clinical trials to achieve a more balanced ratio; and
• Integration of microbiome diagnostics into frontline healthcare
It is also working closely with partners at the National Institute for Health and Care Research (NIHR) to support best practice across the system, addressing barriers that might stop people taking part.
Saba Anwar, senior scientist at the MHRA, said: “With the right tools, we can move away from a ‘one-size-fits-all’ approach and towards truly personalised women’s healthcare. This is a major opportunity to address long-standing inequalities in how women’s health is understood, diagnosed, and treated.”
Ana Sofia Da Silva, Department of Urogynaecology, King’s College Hospital, London, said: “As our understanding of the human microbiome, particularly the vaginal microbiome, continues to grow, we are beginning to uncover its critical role in women’s health and disease. This emerging field holds immense potential to revolutionise our understanding of chronic conditions, reshape diagnostic pathways, and guide future treatments.”
Suenie Park, Microbiome Research Centre, BiowaveW, Seoul, Korea, said: “Our institution has been a committed participant in international initiatives led by the UK’s NIBSC within the MHRA framework, particularly in establishing WHO/NIBSC reference materials for the gut microbiome. Through collaborative efforts to publish a joint paper on trends in women’s health and vaginal microbiome diagnostics, we see a strong opportunity to deepen cooperation between Korea and the UK in this critical area. ”
Emerging research highlights that not only gut but also vaginal microbiome profiles exhibit ethnic variability, Park added.
“We intend to play an active role in the development of vaginal microbiome reference materials, and hope to contribute to women’s health and accelerate innovation in microbiome-based medical technologies.”
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