Vaginal Microbiome Could Revolutionise Women’s Health, Says New MHRA Review

The microscopic bacteria living in women’s bodies could hold the key to transforming healthcare, according to a major new review published on August 7th, 2025, by the Medicines and Healthcare products Regulatory Agency (MHRA).

The review, first released in Frontiers in Cellular and Infection Microbiology, argues that the vaginal microbiome - an ecosystem of bacteria that plays a critical role in reproductive and gynaecological health - remains a “largely overlooked” frontier of medicine. Researchers say that harnessing it could pave the way for earlier diagnoses, personalised treatments, and more effective prevention of a wide range of conditions.

A New Frontier in Women’s Health

While the gut microbiome has become a major research focus over the past decade, the vaginal microbiome has not received the same attention. Yet evidence increasingly shows that the balance of bacteria in the vagina influences fertility, pregnancy outcomes, susceptibility to infection, and even the development of certain cancers.

“We are only beginning to understand how powerful the vaginal microbiome could be as a diagnostic tool,” said Dr Chrysi Sergaki, Head of Microbiome at the MHRA. “This review sets out the case for making this a major focus of women’s health research and development going forward.”

The work is the result of collaboration between the MHRA and leading institutions including King’s College Hospital London, the University of Liverpool, Ewha Women’s University in Seoul, and Biowave W Seoul.

Potential to Transform Diagnosis and Treatment

Current diagnostic tools in women’s health are often limited - sometimes subjective, sometimes slow - leading to delays in treatment and poorer outcomes. The review highlights how microbiome-based testing could overcome these shortcomings by offering fast, non-invasive, and highly personalised options.

Conditions that could benefit include:

• Common infections such as bacterial vaginosis and sexually transmitted infections (STIs).

• Reproductive disorders such as infertility, miscarriage, and preterm birth.

• Chronic conditions such as endometriosis.

• Cancer risk and detection, including gynaecological cancers.

• Menopause-related complications.
  

“As both a clinician and researcher, I witness firsthand how delayed or inaccurate diagnoses adversely affect women’s reproductive health,” said Professor Sunwha Park of Ewha Women’s University. “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.”

Closing the Gender Gap in Research

The review also underscores how historic underrepresentation of women in clinical research has hampered medical progress. One study of 86 randomised controlled trials found women accounted for only 37% of participants. Male-only trials (6.1%) remain nearly twice as common as female-only studies (3.7%), and pregnant or breastfeeding women are rarely included.

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.”

The MHRA says new guidance is already being developed to encourage more inclusive trial designs, ensuring that results better reflect the populations who will use future medicines.

Supporting Innovation in Microbiome Testing

Beyond policy, the MHRA is actively supporting scientists and innovators to accelerate progress in microbiome-based diagnostics. Initiatives include:

• Clearer regulatory guidance for companies developing microbiome-related tests, to streamline approval without compromising safety.

• Developing physical standards to ensure microbiome research is reproducible and comparable across different labs and countries.

• Supporting rapid testing in NHS hospitals, such as DNA-based tests that can identify bacteria and antibiotic resistance within 48 hours—cutting weeks off current timelines.

• Tackling antimicrobial resistance, by working with partners in the UK and globally to track and fight antibiotic-resistant “superbugs” using microbiome science.

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“This is an exciting time for women’s health microbiota diagnostics,” said Dr Laura Goodfellow of the University of Liverpool. “We’ve spent the past 15 years understanding what is normal, and what is 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.”

Building International Collaboration

Researchers also stressed the importance of global cooperation. Suenie Park, from BiowaveW in Seoul, highlighted ethnic differences in microbiome profiles as an area requiring international collaboration: “Emerging research shows that vaginal microbiome profiles vary across populations.

This underscores the importance of developing reference materials tailored to regional needs while also harmonising international standards and guidelines. Through joint efforts with the MHRA, we hope to accelerate innovation in microbiome-based medical technologies.”

A Call for Action

To fully realise the promise of vaginal microbiome diagnostics, the review calls for:

• Increased investment in women’s health research.

• Standardised testing methods.

• Greater inclusion of women in clinical trials.

• Integration of microbiome diagnostics into routine NHS and global healthcare systems.

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“As our understanding of the human microbiome continues to grow, we are beginning to uncover its critical role in women’s health and disease,” said Ana Sofia Da Silva of King’s College Hospital. “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.”

The Bigger Picture

The MHRA emphasises that its efforts are part of a broader mission to close the gender health gap. By working with the Health Research Authority, the National Institute for Health and Care Research, and international partners, the agency aims to create a research landscape that better represents women - including pregnant and breastfeeding women, who are often excluded from trials.

Dr Sergaki summed up the significance of the review: “The vaginal microbiome is not just an academic curiosity - it could be a powerful tool to transform women’s health worldwide. But to get there, we need investment, collaboration, and a commitment to placing women’s health at the centre of research and innovation.”