INOVIQ Reports A$850k Sample Issue but Boosts Diagnostic Sensitivity to 92%

Clinical Validation Disrupted by Sample Quality

INOVIQ Limited (ASX:IIQ) encountered a significant hurdle in its efforts to expand clinical validation of the EXO-OC™ test for early ovarian cancer detection. The company revealed that samples sourced from international biobanks were unsuitable, preventing completion of the intended study expansion. This setback, costing approximately A$850,000, was attributed to sample quality issues rather than any flaw in the test itself. INOVIQ’s chairman Peter Gunzburg expressed the board’s disappointment but reaffirmed confidence in the test’s potential and commitment to meeting industry validation standards.

Algorithm Optimisation Enhances Diagnostic Performance

Despite the validation disruption, INOVIQ achieved a notable technical milestone by optimising the EXO-OC™ algorithm using a previously tested dataset of 500 samples. The refined algorithm demonstrated improved diagnostic metrics, achieving 92.3% sensitivity for early-stage (I/II) ovarian cancer, 92.5% sensitivity across all stages, and 98% specificity against healthy controls and benign gynaecological diseases. These figures suggest robust test performance, supporting the company’s ongoing development plans.

Progress on CAR-Exosome Therapeutic Program

INOVIQ also reported promising advances in its CAR-exosome therapy platform, designed to target solid tumours such as ovarian cancer. Laboratory tests showed strong tumour-killing activity, with CAR-exosomes eliminating up to 90% of ovarian cancer cells within 48 hours. The company is advancing manufacturing readiness, including GMP-grade cell sourcing and selecting a contract development and manufacturing organisation (CDMO), signalling progress towards scalable production.

Financial Position Supports Ongoing Development

Financially, INOVIQ closed the quarter with a cash balance of A$9.353 million, reflecting disciplined capital management despite increased research and development expenditure. Net cash used in operating activities was A$2.516 million, driven by A$1.503 million in R&D costs related to clinical validation and therapeutic programs, alongside higher administration costs mainly due to annual insurance. Operating receipts included A$138,000 from EXO-NET and hTERT product sales and A$125,000 in bank interest.

Next Steps Focus on Single-Site Biobank and Partnerships

Looking ahead, INOVIQ plans to pivot its clinical validation strategy towards using single-site biobanks and nested prospective or real-world sample evaluations. Collaborations with laboratory partners or contract research organisations (CROs) are expected to underpin these efforts, aiming to overcome the challenges faced with international biobank samples. The company is also targeting commercialisation of EXO-OC™ initially as a laboratory-developed test (LDT) in the US market before advancing to in vitro diagnostic (IVD) screening.

INOVIQ is set to host an investor briefing on 14 July 2026 to discuss these developments in detail and outline the pathway to commercialisation, providing a forum for questions and further clarity on the impact of the recent study outcome.