INOVIQ Validates EXO-OC Ovarian Cancer Test, Advances CAR-Exosome Therapy

INOVIQ’s EXO-OC – A Potential Game-Changer in Ovarian Cancer Screening

INOVIQ Limited (ASX – IIQ) has unveiled compelling clinical validation data for its EXO-OC test, a next-generation ovarian cancer screening tool leveraging proprietary exosome isolation technology combined with AI-enhanced biomarker analysis. The test demonstrated an impressive 77% sensitivity across all ovarian cancer stages and a remarkable 100% sensitivity for early-stage (Stage I and II) cancers, with specificity exceeding 99.6%. These performance metrics meet and exceed the stringent criteria required for population screening, addressing a critical unmet need in early ovarian cancer detection where current options are limited or non-existent.

The EXO-OC test utilizes INOVIQ’s EXO-NET platform to isolate exosomes; tiny vesicles released by cells that carry molecular information; and applies a sophisticated machine learning algorithm developed in collaboration with The University of Queensland. This fully automated, high-throughput test is designed to integrate seamlessly into existing clinical laboratory workflows, positioning it well for rapid adoption.

Strategic Commercialisation and Regulatory Pathway

INOVIQ has outlined a clear commercialisation roadmap targeting the US market initially through a Laboratory Developed Test (LDT) pathway with a CLIA-certified laboratory partner, enabling early market entry. Concurrently, the company plans to pursue Breakthrough Device Designation (BDD) and Premarket Approval (PMA) from the US FDA, alongside regulatory filings in Europe, Asia, and Australia. This multi-stage approach aims to facilitate broad clinical adoption and reimbursement over time, with pivotal clinical studies planned involving thousands of asymptomatic post-menopausal women.

Beyond ovarian cancer, INOVIQ is advancing its CAR-exosome therapeutic program targeting triple-negative breast cancer (TNBC) and non-small cell lung cancer (NSCLC). Preclinical in vitro data show CAR-exosomes derived from engineered natural killer cells can kill 88% of TNBC and NSCLC cancer cells within 96 hours. This novel acellular therapy offers potential advantages over traditional CAR-T cell therapies, including reduced toxicity, off-the-shelf availability, and improved tumour penetration.

Positioning as a Leader in Exosome-Based Oncology Solutions

INOVIQ’s integrated platform spans research tools, diagnostics, and therapeutics, underpinned by proprietary exosome technology. The company’s leadership team and advisory board bring deep expertise in oncology, immunotherapy, and commercialisation, supporting its ambition to become a leading exosome company. With a market capitalisation near A$42 million and cash reserves of A$8 million as of March 2025, INOVIQ is well-positioned to execute its FY26 growth catalysts, including expanding EXO-NET customer base, advancing clinical validation, and progressing IND-enabling studies for CAR-exosome therapies.

Strategic partnerships with institutions like The University of Queensland and the Peter MacCallum Cancer Centre further validate INOVIQ’s scientific approach and accelerate development timelines. The company’s focus on patent protection and regulatory compliance underscores its commitment to safeguarding its innovations and maximising commercial potential.