INOVIQ Limited’s (ASX:IIQ) blood test for ovarian cancer screening has successfully completed an independent patient validation of its biomarkers and diagnostic performance, delivering outstanding test results with accuracy of over 94%.
The EXO-OC blood test was performed using a more sensitive and specific method than used in routine pathology testing laboratories.
These results represent a major advancement in OC testing. In this study, exosomes were isolated from more than 500 blood samples, using INOVIQ’s EXO-NET on a fully-automated high-throughput robotic platform. Exosome ovarian cancer biomarkers, previously identified in the OC97 study, were measured using targeted mass spectrometry performed by The University of Queensland’s (UQ) Centre for Extracellular Vesicle Nanomedicine.
All targeted biomarkers were identified in ovarian cancer samples and their diagnostic performance was confirmed using ROC curve analysis and multivariate modelling. EXO-NET isolation of exosomes also identified additional cancer biomarkers for use in the future.
INOVIQ will now move to optimise the blood test on a commercial instrument platform and perform additional clinical validation as a precursor to delivering the test in a clinical laboratory.
“This study demonstrated that the EXO-OC test identified ovarian cancer across all stages with an overall accuracy of over 94%. Notably, the EXO-OC test is particularly accurate in identifying early stages of ovarian cancer, achieving a sensitivity of more than 90% and specificity of 96% for stage I, where women have a 5-year survival rate of over 90%,” the Director of the UQ Centre for Extracellular Vesicle Nanomedicine, Professor Carlos Salomon Gallo, said.
“Importantly, these results confirm that the ovarian cancer biomarkers were validated in an independent sample set, highlighting the robustness and reproducibility of INOVIQ’s EXO-NET exosome isolation technology and UQ’s proprietary biomarkers.”