INOVIQ Limited (ASX:IIQ) has announced a major breakthrough in ovarian cancer screening, revealing new data at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting that its EXO-OC™ test achieved 77% sensitivity and 99.6% specificity across all stages of the disease—and successfully detected all early-stage (I and II) cancers without a single missed diagnosis.
The test, which uses AI-enhanced analysis of exosomal biomarkers and runs on high-throughput automated platforms, was validated in a 532-sample retrospective blinded study and meets global benchmarks for population screening.
With no existing screening tests for asymptomatic, average-risk women, INOVIQ is positioning the technology for regulatory approval and commercial rollout, beginning with a US-based Laboratory Developed Test.
The company has filed a new provisional patent and plans to seek FDA Breakthrough Device Designation.
CEO Dr Leearne Hinch said the technology addresses a critical unmet need and could “transform precision oncology,” while Chairman David Williams described the test as a “non-invasive, accurate and reliable” tool for addressing the world’s most lethal gynaecological cancer.
