Dr Leearne Hinch, CEO of INOVIQ (ASX:IIQ), discusses the company’s progress in developing a screening test for ovarian cancer—an area with no currently approved screening options.
Dr Hinch explains that screening for ovarian cancer has historically been hindered by low disease prevalence and the absence of a single reliable biomarker. INOVIQ’s test uses proprietary exosome technology and advanced AI-driven algorithms to combine multiple biomarkers, offering a more sensitive and more specific alternative to existing blood-based tests.
At the American Society of Clinical Oncology meeting, Innovate presented clinical validation data showing 77% sensitivity and 99.6% specificity across all cancer stages—meeting key clinical benchmarks for population screening. Notably, the test achieved 100% detection of early-stage (stage I and II) cancers with no misdiagnoses.
Dr Hinch outlines a two-step commercialisation strategy:
Initial launch as a laboratory developed test (LDT) with a US partner, targeting release in late 2026.
Subsequent FDA approval as an in vitro diagnostic (IVD), potentially by 2028, with rollout to Europe and Australia to follow.
Pending regulatory engagement and potential “breakthrough device” designation may accelerate timelines.
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Source: Finance News Network
