Home-use diagnostic concept targets pre-symptomatic mastitis detection

A new at-home diagnostic device concept demonstrates how somatic cell count (SCC) in breastmilk can be measured to identify mastitis before symptoms appear.

Hermione Blakiston, an innovation and R&D consultant at Sagentia Medical, says the concept, named celleste, was designed with empathy, ease of use, and the realities of early parenthood in mind:

“One in four mothers experience mastitis, a painful inflammation of the breast that can lead to infection and even sepsis if left untreated. Early detection makes all the difference, yet today there are no dedicated, pre‑symptomatic diagnostic solutions. The aim of celleste is to make daily at‑home checks simple and intuitive, giving women confidence and control over their breast health.”

The celleste concept shows how an established inflammation biomarker can be translated into an accessible home‑use prevention tool, addressing a significant and long‑standing gap in postnatal care. It is designed to quantify SCC in breastmilk using an interdigitated electrode sensor that detects electrical response associated with elevated cell density – a consequence of inflammation.

Clinical data indicates that SCC levels above 2.5 x 10⁵ cells/ml reliably differentiate healthy and mastitic patients prior to symptom onset, providing a defined biomarker threshold for early 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 breastmilk on the device’s biosensor. Mothers would receive immediate visual feedback on the handheld device, while a companion app would provide tailored guidance on feeding, prevention, symptom management, and when to seek clinical support.

Sagentia Medical developed this concept to demonstrate how clinically validated biomarkers can be embedded into practical diagnostic formats to enable earlier, non‑pharmacological, user-led intervention.

As Hermione Blakiston explains: “With unmet needs spanning prevention, diagnosis, treatment and long-term management, women’s health remains an important area for healthcare innovation. The celleste concept demonstrates how established technologies can be applied in new ways to address gaps in care. At Sagentia Medical, we partner with clients across the healthcare continuum, supporting early-stage concept development as well as multi-year product development programmes.”

By focusing on mastitis, a condition affecting millions of women globally each year, the celleste concept reinforces the potential for biomarker-led innovation to reduce persistent inequities in women’s health.

More information about the development of celleste is available here.