Melbourne-headquartered INOVIQ has announced significant results from its EXO-OC ovarian cancer test presented at the American Society of Clinical Oncology Annual Meeting in Chicago.
The test uses proprietary technology to isolate exosomes and combines multiple exosomal biomarkers in an AI-enhanced algorithm to enable the early and accurate detection of ovarian cancer.
The company reported positive high-level results from a biomarker study validating protein biomarkers in late 2024. It worked with computational scientist Professor Amanda Barnard to independently analyse its miRNA biomarker data and develop AI machine-learning algorithms to enhance the detection of early-stage ovarian cancer.
The test is run on a fully automated, high-throughput instrument suitable for clinical pathology laboratories, capable of processing over 500 samples daily.
INOVIQ said that in a 532-sample, retrospective, blinded, case-control study, the test demonstrated 77 per cent sensitivity at 99.6 per cent specificity for the detection of ovarian cancer across all stages. The test accurately detected all Stage 1 and 2 ovarian cancers, with no missed early-stage diagnoses.
An Australian Provisional Patent Application (APPA) was filed on 29 May 2025 to secure intellectual property rights covering various protein and RNA biomarker combinations and methods for the exosome ovarian cancer test.
Ovarian cancer is usually asymptomatic in the early stages of the disease. It is often diagnosed at a late stage after symptoms have appeared, resulting in a 5-year survival rate of only 49 per cent. Early detection may increase 5-year survival from 30 per cent to 93 per cent.
INOVIQ CEO Dr Leearne Hinch said, “Our EXO-OC test addresses a critical unmet need for early detection of ovarian cancer. INOVIQ is now positioned as a global leader in exosome technology, offering best-in-class exosome isolation and diagnostic solutions that can transform precision oncology. We are focused on the rapid commercialisation of our test, first as a Laboratory Developed Test and then as a regulatory approved In Vitro Diagnostic for ovarian cancer screening.”
Chairman David Williams added, “Ovarian cancer is the eighth most common cancer in women. Globally, there were over 314,000 new cases and 207,000 deaths in 2020. There are no recommended screening tests for ovarian cancer in average-risk, asymptomatic women so it is very exciting if our test can offer a non-invasive, accurate and reliable diagnostic test for this significant unmet need.”
