Validating the application of a first-in-class human serum-functional immunodynamic status (sFIS) assay as bona fide immuno-oncology biomarker

Biomarkers linked to cancer patient’s immunological status are pivotal for reliable decision making regarding therapy options and patient management. However, biomarkers that can capture dynamic functional immune-signaling in non-invasive and personalised manner are currently unavailable. Thus, we established a novel, ‘first-in-class’, serum-functional immunodynamic status (sFIS) assay, utilising an 'in sitro' (in situ/in vitro) approach to interrogate the serum “immunome”. In ovarian cancer patients, sFIS assay successfully estimated the risk of malignancy and distinguished differential survival, hence exemplifying its co-diagnostic/co-prognostic utility. But, beyond this proof-of-concept, further analytical/ clinical validation of sFIS assays’ broad utility across multiple cancer-types and its immuno-oncological application is critically required. Hence, in this study we aim to test sFIS assay’s performance across sera from >800 patient across 5 different cancer-types, with or without anticancer interventions (surgery, chemo/radio/immuno-therapy). Together, these inquiries will greatly enhance the socio-economic impact of sFIS assay thereby creating bright valorisation and leverage effect opportunities.

Keywords:Cancer, Immuno-oncology, Biomarkers, Immune-signalling, Patient serum analysis

Disciplines:Cancer biology, Biomarker evaluation, Applied immunology