WOMEN’S HEALTH


differently or disproportionately, as well as female-specific health maters. While women comprise half the global population, women’s health receives only 6% of private healthcare investment worldwide.3


Such chronic underfunding


reduces the incentive and capacity to build evidence, validate biomarkers in diverse populations, and develop user-centred diagnostic technologies. Together, these factors help explain


why promising biomarkers in women’s health, including those for mastitis and endometriosis, have not yet been leveraged in routine care. Improving female diagnostics requires the integration of biological insight with practical design and behavioural considerations, and a new investment mindset that recognises women’s health as both a scientific priority and an economic opportunity.


A biomarker for mastitis Mastitis detection is a prime example of an unmet need in women’s healthcare. This common, painful post-natal condition has implications for the physical and emotional wellbeing of mothers and infants. When identified early, interventions such as increasing the frequency of breastmilk expression can reduce inflammation and prevent infection. Supporting women to implement these strategies promptly may reduce the need for clinical intervention and the use of antibiotics. At present, there is no home-use


solution for early detection, and diagnosis typically occurs once breast tissue has already become inflamed or infected. However, a precedent for earlier detection can be found outside human healthcare. In dairy farming, somatic cell count


(SCC) has long been used as a routine indicator of mastitis in cows. SCC reflects the immune response within the udder and is widely adopted as a proxy for subclinical infection. More recently, diagnostic approaches that combine SCC with additional parameters, such as differential cell counts, have been shown to improve sensitivity and specificity, enabling earlier and more precise detection of mastitis at the individual animal level. This builds on the strengths of SCC, while addressing its known limitations as a non-specific biomarker.4 Similar principles are now being


explored in women’s health. A recent pilot study demonstrated that SCC thresholds established in the dairy industry (more than 2.5 x 105


cells/mL) may also be


effective in identifying subclinical mastitis in lactating women. Elevated SCC levels were shown to correlate strongly with inflammatory markers


The celleste device was designed to enable simple, intuitive testing at any point during the day, requiring only a few drops of milk to generate a rapid indication of SCC.


such as interleukin-8, indicating that SCC could serve as a meaningful indicator of otherwise asymptomatic breast inflammation.5 Successful use of the SCC biomarker


in dairy farming highlights how routine, repeatable measurement embedded into everyday scenarios can enable earlier intervention at scale. Translating this principle into human healthcare could help accelerate the adoption of new biomarker-led diagnostics. Doing so requires more than technical insight; it demands a holistic approach to feasibility, usability and implementation. To explore how this could be achieved, we developed a concept – the celleste device – aimed at enabling earlier detection of mastitis in lactating women.


Designing for real-world post-natal care Our work combined user research, concept development and exploratory microbiological testing to assess how the concept might function in real- world setings. Through interviews and co-creation sessions with mothers, we examined potential care pathways and daily use scenarios, ensuring the design aligned with the practical demands of early parenthood. In parallel, laboratory testing using


representative breast milk samples evaluated whether impedance-based measurements could reliably detect inflammation-related SCC changes. Our sensing approach was benchmarked against gold-standard cell counting methods using representative samples, confirming its ability to detect pre-symptomatic changes with near- instant results. Clinical data indicate that SCC levels above 2.5 x 105


detection. Sagentia Medical conducted laboratory testing using representative samples to confirm that impedance-based measurements could detect these changes, supporting the feasibility of translating SCC into a home-use diagnostic format. Powered by impedance-based


technology, which is well-established in the in vitro diagnostics market, celleste would provide instant readings from just a few drops of breast milk on the device’s biosensor. Together, these activities provided early


evidence for both the technical feasibility and the practical viability of a home-use diagnostic grounded in SCC. Insights from user research highlighted


the diversity of post-natal experiences and the practical constraints faced by mothers. Feeding methods, daily routines and home environments varied significantly, yet a consistent theme emerged: solutions must fit seamlessly into busy, often unpredictable schedules. The celleste concept was designed to enable simple, intuitive testing at any point during the day, requiring only a few drops of milk to generate a rapid indication of SCC. This supports regular, proactive monitoring of breast health, allowing mothers to spot early signs of inflammation before symptoms develop. Form factor was another important


cells/mL reliably


differentiate healthy and mastitic patients prior to symptom onset, providing a defined biomarker threshold for early


consideration. To be effective, the device needed to be portable, discreet, and easy to clean, with simple and intuitive sample collection. Immediate, easy to interpret feedback was central to the concept. The device provides a simple indication of whether further action may be needed, while an optional companion app provides more detailed information and tailored guidance on symptom management. Importantly, our focal point was


early, preventative action rather than responding to established symptoms. Where elevated somatic cell levels are


September 2026 WWW.PATHOLOGYINPRACTICE.COM 47


Sagentia Medical


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