INOVIQ to Rework EXO-OC Study Path after Sample Quality Setback

INOVIQ (ASX: IIQ) has been forced to revise the clinical development path for its EXO-OC ovarian cancer test after concluding samples from an expanded retrospective study were unsuitable for performance evaluation.

The setback followed analysis of about 1,200 biobanked plasma samples from the ovarian cancer case-control group of a planned study of up to 2,000 samples.

INOVIQ largely attributed the issue to significant variability in external sample quality across five commercial biorepositories from multiple sites.

The company separately reported improved performance from continued optimisation of EXO-OC using its original 500-sample dataset, with the revised algorithm achieving 92.3% sensitivity for stage I/II ovarian cancer and 92.5% sensitivity across all stages at 98% specificity.

Study Objectives Missed

INOVIQ had designed the expanded retrospective study to evaluate EXO-OC performance across ovarian cancer stages, high-risk groups, and confounding diseases.

Data analysis completed in June identified that one biorepository, which supplied 616 samples and 69% of the cancer cases, provided samples showing reduced protein and microRNA (miRNA) levels consistent with degradation.

INOVIQ also identified significant variability across all biorepositories, likely due to provider-specific pre-analytical collection and logistical factors outside the study’s control.

The company confirmed the issues meant the 1,200-sample cohort could not be used to evaluate EXO-OC test performance.

Commercial Path Reset

INOVIQ now expects to evaluate the high-risk and confounding disease groups, previously scheduled for analysis in the second half of 2026, in a new study.

Future EXO-OC studies may use samples collected under INOVIQ’s standardised protocol through a single-site nested prospective clinical study or a real-world study with a laboratory partner or contract research organisation.

The company maintained the sample quality issues were unrelated to the performance of its EXO-NET technology or the EXO-OC test.

However, the result removes the expanded retrospective study as a near-term validation step and forces INOVIQ to rely on a redesigned evaluation pathway for future performance evidence.

Algorithm Still Improving

EXO-OC is an exosome-based blood test in development for early detection and screening of ovarian cancer.

The test uses INOVIQ’s proprietary EXO-NET technology to isolate exosomes and combines multiple exosomal miRNA biomarkers and CA125 in an AI and machine learning algorithm.

Continued tuning of the algorithm in the original 500-sample dataset improved all-stage sensitivity from the previously reported 77% at 99.6% specificity to 92.5% at 98% specificity.

The model retained strong early-stage performance, with 92.3% sensitivity for stage I/II disease at 98% specificity.

Addressable Study Issues

Founding scientist Professor Gregory Rice said the enhanced algorithm remained suited to early detection and screening of ovarian cancer.

“Data analysis in this study identified significant provider-related variability and sample quality issues from the multiple biorepositories,” he said.

“While study objectives were not achieved, the findings inform our future studies and the issues are addressable.”

“I am confident that we can further refine the standardised protocol, biomarkers, and algorithm to deliver the EXO-OC test for early detection of ovarian cancer.”

Chief executive officer Dr Leearne Hinch said INOVIQ remained focused on advancing EXO-OC toward laboratory-developed test readiness and commercialisation.

US Test Strategy

INOVIQ still plans to first commercialise EXO-OC as a laboratory-developed test (LDT) in the US for early detection of ovarian cancer.

The company is targeting women at high risk of developing ovarian cancer, including those with BRCA1/2 mutations, Lynch Syndrome, or a family history.

INOVIQ expects the LDT path to provide earlier patient access and create potential for a proprietary laboratory analyses reimbursement code.

The company has also advanced its intellectual property position, with an international patent application filed on 29 May covering protein and RNA biomarker combinations and methods for the EXO-OC test.