The vaginal microbiome is a largely overlooked area of medicine that could dramatically improve outcomes for millions of women, concludes a new review co-authored by the Medicine and Healthcare products Regulatory Agency (MHRA) published today (7 August).
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 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 last 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 9 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.
What the MHRA is doing to support 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 doing this by:
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Creating clearer guidance for microbiome tests: We are 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.
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Developing physical standards: To accurately standardise current methods used to study the microbiome, to ensure reproducibility and comparability of studies within and between establishments. This is especially important for gut, skin, vaginal, oral and respiratory-related microbiome tests.
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Supporting new, faster testing in hospitals: We 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. This kind of technology could help doctors treat infections more quickly and accurately.
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Helping in the fight against superbugs: The MHRA is also working on ways to support microbiome-based approaches to fight antibiotic-resistant infections. We are working with partners across the UK and globally to develop better standards and methods to track these superbugs in diagnostic tests but also in the environment for surveillance.
The MHRA is making it easier and safer to bring microbiome-based tests into real-world healthcare. We are making the rules clearer, improving test accuracy, speeding up reviews, and supporting National Health Service (NHS) trials – all to help people get better diagnostics, preventative measures and treatments in the future.
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:
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Increased investment in women’s health research
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Standardised microbiome testing methods
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Wider inclusion of women in clinical trials to achieve a more balanced ratio
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Integration of microbiome diagnostics into frontline healthcare
What the MHRA is doing to support more diversity in health research
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We are working closely with sponsors, researchers, ethics committees and global regulators to promote trial designs that better reflect the populations who will ultimately use these medicines.
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We are collaborating closely with the Health Research Authority (HRA) on new guidance to support researchers to be more inclusive from the very start and better represent the population that will use the medication.
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We are also working closely with our 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.
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We support the use of preclinical evidence and modelling to enable safer participation of underrepresented groups, including pregnant and breastfeeding women, including through the UK Centre of Excellence on In-Silico Regulatory Science and Innovation.
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. A deeper understanding of how the microbiome is linked to disease will not only benefit the future of healthcare but also represent a significant step towards truly personalised care.”
Laura Goodfellow, Women’s and Children’s Health, University of Liverpool, said:
“This is an exciting time for women’s health microbiota diagnostics – we’ve spent the past 15 years understanding what is normal, and not. Now vaginal microbiota tests are being developed that can help identify pathology and guide treatment. I look forward to these being brought into routine clinical practice in the next 5-10 years to improve outcomes for women and girls.”
Suenie Park, Microbiome Research Centre, BiowaveW, Seoul, Korea, said:
“Over the years, 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. We specialize in the development of standardized reference materials and are actively engaged in the advancement of microbiome-based in vitro diagnostic devices.
“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. This underscores the importance of developing reference materials tailored to regional needs while simultaneously working toward harmonized international standards and guidelines.
“Looking ahead, we intend to play an active role in the development of vaginal microbiome reference materials, as initiated by MHRA Science and Research Group. By strengthening our collaborative framework and pursuing efficient standardization strategies, we hope to contribute to women’s health and accelerate innovation in microbiome-based medical technologies.”
Sunwha Park, Department of Obstetrics and Gynaecology, College of Medicine, Ewha Women’s University, Seoul, Korea, said:
“As both a clinician and researcher, I witness firsthand how delayed or inaccurate diagnoses adversely affect women’s reproductive health. Vaginal microbiome testing represents a groundbreaking advancement, offering earlier and more precise detection and treatment—especially in high-impact areas such as preterm birth and infertility.
“We’ve been identifying key biomarkers from the vaginal microbiome associated with preterm birth, vaginitis, and cervical cancer. Now, the urgent next step is to translate these findings into everyday clinical diagnostics to truly revolutionise women’s health outcomes.”
Notes to editors
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The review was published in Frontiers in Cellular and Infection Microbiology Volume 15 – 2025 doi: 10.3389/fcimb.2025.1595182.
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The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
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The MHRA is an executive agency of the Department of Health and Social Care.
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For media enquiries, please contact the newscentre@mhra.gov.uk, or call on 020 3080 7651.
