Women’s health
performance from menstrual blood-based biomarkers, with sensitivity of up to 95% and specificity of up to 90% across multiple endometriosis types. These figures compare favourably with many circulating blood biomarkers and highlight the potential of menstrual blood as a diagnostic sample. Further research, including the Research OutSmarts Endometriosis (ROSE) study,6
demonstrates
differences in stromal cell activity using single-cell RNA sequencing of menstrual blood, reinforcing the biological relevance. Much of the current evidence is derived
from small, single-centre studies, and further validation would be needed for menstrual blood-based diagnosis to be integrated into routine clinical practice. There are also practical considerations around sample collection, stabilisation and processing. This reflects a broader pattern across women’s healthcare. While promising biomarkers continue to be identified, translating them into practical diagnostic tools requires more than scientific validity. Progress depends on building the surrounding ecosystem for early detection, including appropriate sampling methods, robust device design, usable workflows, and clear clinical pathways. Aligning biomarker innovation with compelling value propositions for payers, providers, and investors is essential to secure the support needed for these tools to reach routine clinical and home use settings.
Closing diagnostic gaps As the mastitis and endometriosis examples demonstrate, identifying promising biomarkers is only one step towards improving diagnosis in women’s healthcare. For biomarkers to deliver real-world benefit, they must be measurable in ways that are reliable and reproducible, and presented in a form that supports clinical decision-making. The breastmilk and menstrual blood examples show that the practicalities of sample collection and handling can ultimately determine whether a diagnostic approach is viable in routine use.
Closing diagnostic gaps therefore requires
more than continued biomarker discovery. Progress depends on the co-ordinated development of the wider diagnostic ecosystem, including practical sampling strategies, manufacturable and usable device formats, clear result outputs, and defined pathways for action within clinical and community care. Early consideration of regulatory pathways, intended use, and reimbursement strategy is essential to ensure new diagnostic tools can progress beyond research and pilot settings. These challenges are not limited to female-
specific conditions. Similar patterns can be seen in conditions that affect women disproportionately or differently to men, such as Alzheimer’s disease. In this case, emerging blood-based biomarkers offer the potential for detection years before cognitive symptoms emerge, yet integration into care pathways that support earlier therapeutic intervention, or prevention, remains a significant barrier. A systems-level approach also includes designing for the environments where women first seek help, whether at home, in primary care, or within community settings. It requires expanding the evidence base to validate biomarkers across diverse female populations, addressing long-standing research biases that have limited the generalisability of many diagnostic tools. In many cases, the core technologies and biological insights already exist. The priority now is to integrate them effectively into diagnostic tools that can deliver impact at the point of need. Doing so will help narrow diagnostic gaps and contribute to a more equitable healthcare landscape for women.
differential somatic cell count in the detection and management of mastitis, Journal of Dairy Science, December 2026, Available from:
https://www.sciencedirect.com/science/ article/pii/S0022030225008306
5. Angelopoulou, A., Harris, H.M.B., Warda, A.K., O’Shea, C., Lavelle, A., Ryan, C.A, et al, Somatic cell count as an indicator of subclinical mastitis and increased inflammatory response in asymptomatic lactating women, Microbiology Spectrum, 27 August 2024, Available from:
https://pmc.ncbi.nlm.nih.gov/ articles/PMC11448179/
6. Research OutSmarts Endometriosis, Robert S. Boas Center for Genomics and Human Genetics, Accessed 14 April 2026 at:
https://feinstein.northwell.edu/institutes- researchers/institute-molecular-medicine/ robert-s-boas-center-for-genomics-and- human-genetics/rose-research-outsmarts- endometriosis
About the authors
Hermione Blakiston, MSc, CPhys MInstP, R&D Consultant at Sagentia Medical With an academic background in computational and theoretical physics,
CSJ
References 1. Endometriosis UK Release New Report Highlighting Alarming Increase in Endometriosis Diagnosis Times, Endometriosis UK, 2 March 2026, Available from: https://
www.endometriosis-uk.org/endometriosis- uk-release-new-report-highlighting-alarming- increase-endometriosis-diagnosis-times
2. Devlin, H., Women in UK waiting almost nine years for endometriosis diagnosis, study finds, The Guardian (online), 4 March 2024, Available from:
https://www.theguardian. com/society/2024/mar/04/women-in-uk- waiting-almost-nine-years-for-endometriosis- diagnosis-study-finds
3. Women’s Health Investment Outlook, World Economic Forum, January 2026, Available from:
https://reports.weforum.org/docs/WEF_ Womens_Health_Investment_Outlook_2026.pdf
4. Burner, C., Callaway, T.R., Ryman, V.E., Graduate Student Literature Review: Utilization of
Hermione’s expertise spans optics and sensor technology, particularly within diagnostic, surgical, and women’s health applications. Her projects encompass IP landscaping and technical due diligence, as well as the design and development of demonstrator devices for pre-clinical testing across clinical settings worldwide. Hermione excels at translating innovative technologies into tangible products that enhance patient outcomes.
Erica Kantor, CEng, Commercial Lead for Surgical and Women’s Health at Sagentia Medical As a Chartered Mechanical Engineer with 11+ years’ experience
in medical device R&D, Erica leads complex development programmes from strategy to manufacture. In women’s health, Erica works at the intersection of technology, usability and commercial strategy to help address systemic gaps and accelerate meaningful, equitable outcomes for women.
June 2026 I
www.clinicalservicesjournal.com 29
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72
