Female sex hormones play an essential role in regulating physiological and reproductive function throughout women’s life course. Alterations in female sex hormone levels are associated with physiological changes, decreased reproductive capabilities, and increased risk for diseases. Hormone therapies (e.g. menopausal hormone therapy, puberty induction, hypogonadism treatment, hormone therapy for cancer, gender-affirming hormone therapy) and assisted reproductive technologies are commonly used to address these factors. In this context, reliable and scalable monitoring of female sex hormones is critical for the assessment of therapeutic efficacy, clinical-decision-making and personalization. 

However, there are major barriers currently preventing widespread female sex hormone profiling: 
i) need for sampling at the clinic
ii) complex equipment at central laboratories without immediate test results
iii) limited specificity and multiplex capacity. 

Thus, there is a clear unmet medical need for better translational technologies that could in the future be adapted for continuous sensing as women undergo their normal daily routine, which would revolutionise the care of women with reproductive disorders and address health gaps in the wider female population. To this end, CSEM develops innovative sensing technologies, capitalizing on their knowhow in microtechnology, biosensors and electronics. The focus is on the emerging electrochemical aptamer-based sensing approach, enabling rapid, sensitive and repeatable determination of female sex hormone profiles. In FemSense, CSEM joins forces with endocrine researchers from INSEL/UniBE, to set the clinical requirements and use cases, to benchmark CSEM’s technology capabilities and performance and transfer novel female sex hormone sensing technologies towards clinical application. The technology development and evaluation process will benefit from two clinical studies in premenopausal and postmenopausal women with high frequency profiling of female sex hormones using the current gold standard liquid chromatography mass spectrometry. Insights gained from this project have the potential to transform the clinical care of women throughout their lifespan by advancing the field towards real-time in vivo female sex hormone monitoring.