INOVIQ Advances Cancer Diagnostics with 94% Accurate Ovarian Test and Therapeutic Breakthroughs

INOVIQ's Growing Footprint in Exosome Diagnostics

INOVIQ Limited (ASX:IIQ) has reported a robust December quarter marked by key milestones across its cancer diagnostic and therapeutic pipeline. Central to its progress is the expansion of its EXO-NET platform, a pan-exosome capture technology that isolates extracellular vesicles from body fluids for biomarker discovery. The customer base for EXO-NET, distributed globally through Promega Corporation, grew from 29 to 41 during the quarter, with strong uptake across Europe, North America, and Asia-Pacific.

This growth reflects broad applications spanning oncology, neurology, cardiac disease, and more, underscoring the versatility and scalability of EXO-NET in research and diagnostic development. INOVIQ and Promega have also enhanced promotional efforts and developed combination products integrating EXO-NET with RNA isolation workflows, positioning the platform for increased adoption.

Breakthrough in Ovarian Cancer Screening

Perhaps the most striking development is the ovarian cancer screening test (EXO-OC), which demonstrated outstanding diagnostic performance with over 94% accuracy in an independent validation study. Utilizing EXO-NET for exosome isolation and targeted mass spectrometry for biomarker detection, the test achieved 92% sensitivity at 96% specificity across all ovarian cancer stages, including early-stage detection.

This advancement represents a significant leap forward in early ovarian cancer detection, a notoriously challenging area. INOVIQ plans to optimize the test on commercial platforms and pursue further clinical validation, aiming for regulatory approval as a laboratory-developed or in vitro diagnostic test.

Innovative Therapeutics Targeting Breast Cancer

On the therapeutics front, INOVIQ achieved proof-of-concept for its CAR-NK-exosome program targeting triple-negative breast cancer cells. By engineering natural killer cells to produce exosomes bearing chimeric antigen receptors, the company demonstrated dose-dependent killing of aggressive breast cancer cells in vitro, with over 30% cell death at the highest dose tested.

This cell-free therapeutic approach offers potential advantages over traditional CAR-T therapies, including improved safety and manufacturing scalability. Upcoming milestones include enhancing exosome yield and potency and conducting in vivo studies to establish dosing and efficacy.

Refining Breast Cancer Monitoring with neuCA15-3

INOVIQ’s neuCA15-3 test, designed for breast cancer monitoring, also reached a critical milestone by confirming disease specificity. The test accurately distinguished breast cancer patients from those with non-cancer conditions that can elevate CA15-3 levels, outperforming an FDA-approved comparator assay. This specificity could reduce false positives and improve clinical monitoring.

Next steps include publication of scientific findings, scaling to high-throughput platforms, and securing commercial laboratory partnerships.

Financial Position and Outlook

Financially, INOVIQ ended the quarter with a healthy cash balance of $9.476 million, bolstered by a $1 million R&D tax incentive refund. Operating cash outflows were modest at $542,000, reflecting ongoing investment in research and development, staff, and corporate costs. The company’s prudent cash management supports its ambitious development and commercialization plans over the coming year.

Chairman David Williams and CEO Dr Leearne Hinch highlighted the de-risking of INOVIQ’s pipeline through these milestones and the company’s commitment to expanding its exosome isolation tools, diagnostics partnerships, and revenue growth from EXO-NET sales.