Sagentia Medical, a specialist science and engineering consultancy, has developed celleste, a home-use diagnostic device concept designed to detect mastitis before symptoms appear by measuring somatic cell count (SCC) in breastmilk.
One in four mothers experience mastitis, a painful breast inflammation that can lead to infection and sepsis if left untreated. Despite this prevalence, there are currently no dedicated pre-symptomatic diagnostic solutions. 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.
The celleste concept uses impedance-based technology – well-established in the in-vitro diagnostics market – to provide instant readings from a few drops of breastmilk on a biosensor. Mothers would receive immediate visual feedback on the handheld device, while a companion app would offer guidance on feeding, prevention, symptom management, and when to seek clinical support.
Sagentia Medical conducted laboratory testing using representative samples to confirm that impedance-based measurements could detect the relevant SCC changes, supporting the feasibility of translating the biomarker into a home-use format.
“One in four mothers experience mastitis, a painful inflammation of the breast that can lead to infection and even sepsis if left untreated,” said Hermione Blakiston, innovation and R&D consultant at Sagentia Medical. “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.”
Celleste is currently a concept demonstrating how clinically validated biomarkers can be embedded into practical home diagnostic formats – not yet a commercial product. Sagentia Medical developed it to illustrate the potential for biomarker-led innovation in postnatal care, an area that remains significantly underserved relative to the number of women affected.
