WOMEN’S HEALTH
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 patern across
Micrograph of endometriosis of the ovary (haematoxylin and eosin [H&E] stain). Endometriosis studies have reported encouraging performance from menstrual blood-based biomarkers, with sensitivity of up to 95% and specificity of up to 90% across multiple types of the condition.
detected, users can be guided towards practical, proactive steps to help reduce inflammation, such as adjusting feeding paterns, applying heat, or expressing milk from the affected breast. If symptoms develop or persist, appropriate escalation to clinical care can be prompted. This approach could support structured post- natal care pathways, enabling earlier intervention within community setings. Identifying issues before symptoms escalate may reduce the need for GP consultations and antibiotic prescription through consistent, preventative care. Overall, the celleste concept illustrates
how clinically relevant biomarkers can underpin practical tools that support early detection in everyday setings. By linking biomarker measurement to clear guidance, it has the potential to reduce uncertainty, support self-management, and enable timely intervention within existing care pathways.
Opportunities in endometriosis diagnosis Harnessing known biomarkers in accessible diagnostic devices could also
support earlier diagnosis of endometriosis. Current diagnostic pathways rely on imaging techniques, such as transvaginal ultrasound and MRI, both of which have variable sensitivity across different forms of the disease. Laparoscopic surgery remains the current reference standard, but its invasive and resource-intensive nature can contribute to significant delays in diagnosis. As a result, there is growing interest
in a range of non-invasive approaches, with sample types including venous blood, saliva, and menstrual blood being investigated for their diagnostic potential. Among these, menstrual blood has emerged as a particularly promising sample, as it contains endometrial cells, immune components, and inflammatory markers shed directly from the uterus, providing insight into the disease environment. Studies have reported encouraging
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
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 setings.
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 breast milk 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
Many women first seek support at home, in community care, or in primary care,
creating opportunities to shift elements of diagnosis to an earlier point in the pathway
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requires more than continued biomarker discovery. Progress depends on the coordinated 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 setings. These challenges are not limited
to female-specific conditions. Similar paterns can be seen in conditions that affect women disproportionately or differently to men, such as Alzheimer’s
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