GOV.UK New review highlights untapped potential of the vaginal microbiome in women’s health
We are delighted to share this government press release published on the 7th August 2025.
A recent review by the Medicines & Healthcare products Regulatory Agency (MHRA) has concluded "vaginal microbiome testing has the potential to revolutionise women's health by enabling earlier, more accurate and more personalised diagnosis and treatment of a range of conditions - including infertility, miscarriage, preterm birth, gynaecological cancers and menopause related complications."
Dr Chris Sergaki, Head of Microbiome at MHRA, states: “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.”
Women’s health has historically been underrepresented by lack of female research data and subsequent poor diagnosis and treatment plans. However, research in the area of vaginal microbiome in recent years has been expanding greatly and revealing fascinating associations between health outcomes and microbial composition.
The team here at Pelvic Relief are really pleased to see this area of healthcare being formally recognised. For a decade now we have been working to support women with pelvic health options with many success stories, and have ourselves launched a vaginal microbiome test to facilitate better clinical outcomes for women across gynaecological, urology and fertility healthcare.
The MHRA have pledged to support microbiome testing by creating clear guidelines for microbiome testing, encouraging reproducibility and comparability across studies, and supporting testing accessibility in healthcare settings.
Our laboratory team and medical professionals are keen to work closely and in line with the MHRA’s guidance to safely and effectively bring vaginal microbiome testing and insights into healthcare settings where women can really benefit.
Links to the Government Press release and the Vaginal Microbiome Review document:
Comments from the MHRA team about the vaginal microbiome’s role in healthcare:
“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.”
- Saba Anwar, Senior Scientist at the MHRA
“This emerging field holds immense potential to revolutionise our understanding of chronic conditions, reshape diagnostic pathways, and guide future treatments.”
- Ana Sofia Da Silva, Department of Urogynaecology, King’s College Hospital, London
“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.”
- Laura Goodfellow, Women’s and Children’s Health, University of Liverpool
“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.”
- Sunwha Park, Department of Obstetrics and Gynaecology, College of Medicine, Ewha Women’s University, Seoul, Korea
REVIEW FINDINGS - SUMMARY
Vaginal dysbiosis can impact a range of women’s health, including gynaecological, urinary and fertility care.
Vaginal microbiome diagnostics for vaginal infections
Specific alterations in the vaginal microbiome may serve as early biomarkers for detecting vaginal infections, specifically a reduction in lactobacillus. Vaginal infections include BV, STIs and candidiasis, which are common yet poorly diagnosed and managed. Vaginal microbiome testing will enable clinicians to distinguish between different classifications of dysbiosis and guide targeted treatment approaches, which will not only improve patient outcomes but also contribute to antimicrobial resistance (AMR) stewardship.
Vaginal microbiome diagnostics in gynaecology oncology
Gynaecological cancers account for 14% of new cancer diagnoses in women globally, with cervical cancer being the most prevalent and responsible for approximately 350,000 deaths in 2022. This malignancy is primarily caused by persistent infection with high-risk HPV, which is more likely in women with dysbiosis of the vaginal microbiota.
Emerging research suggests a potential link between the microbiome and endometrial cancer, with persistent inflammation leading to increased activation of inflammatory cytokines and subsequent tumour genesis at the endometrial level. Although evidence linking altered microbiomes with ovarian cancer is limited, some studies have shown associations between ovarian cancer and elevated levels of Prevotella, Bacteroides, and Proteobacteria.
In all cases of gynaecological cancers, there is potential for use of a non-invasive vaginal microbiome screening test to screen for bacteria species and assess an individual’s risk factors for inflammation and possibly cancers, and most importantly intervene with vaginal microbiome balancing action plans.
Vaginal microbiome diagnostics for polycystic ovary syndrome (PCOS), endometriosis and adenomyosis
Recent evidence has associated microbial composition with PCOS, specifically involving Mycoplasma, Prevotella, Actinomyces, Gardnerella, and Streptococcus species. One study reported that Mycoplasma was the most distinguished genus in PCOS. These findings identify potential biomarkers that could be implemented in clinical settings as part of a routine point-of-care test for the diagnosis of PCOS, offering faster results, improved accessibility, and the potential for earlier intervention and personalised treatment in clinical settings.
Similarly, observed differences in bacterial abundance between control and adenomyosis groups highlight the potential of specific microbial species to serve as biomarkers for the condition.
Moreover, researchers have found a bi-directional relationship between the microbiome and the development of endometriosis, indicating that any changes in the host’s microbiome can significantly affect the onset and progression of the condition. This highlights the critical need to explore the connection between the microbiome and endometriosis to allow earlier, more accurate diagnosis.
Vaginal microbiome diagnostics for fertility and pregnancy-related complications
Recent research has increasingly focused on the role of the female reproductive tract microbiota, particularly the vaginal microbiome, in both baseline fertility and fertility treatment outcomes. A more diverse vaginal microbiota and a depletion of Lactobacillus species are linked to reduced baseline fertility and lower success rates in assisted reproductive technologies such as in vitro fertilisation (IVF).
Vaginal dysbiosis has been associated with poorer fertility outcomes from conception, miscarriage, to preterm birth and newborn infection. Vaginal microbiome screening has the potential to support the development of treatment plans and better fertility outcomes.
Vaginal microbiome diagnostics and genitourinary syndrome of menopause (GSM)
It has been observed that in postmenopausal women, there is a decrease in Lactobacillus species and a higher abundance of genera including Anaerococcus, Peptoniphilus, and Prevotella, which could play a role in the clinical presentation of GSM. Consequently, a microbiome-based diagnostic test that monitors the abundance of Anaerococcus, Peptoniphilus, and Prevotella species may offer valuable insights into the pathogenesis and progression of GSM.
FINAL WORDS
Overall, the incorporation of microbiome diagnostics into clinical workflows represents a critical advancement in women’s health and we are excited to work in this area of health at a time of exciting developments for women.
