• Study revealed inconsistent miRNA biomarker levels across biorepositories
• Sample quality issues impacted test performance
• INOVIQ plans technical review, algorithm refinement, and new sample sourcing
• No impact on commercialization strategy
• Management accountability under review

INOVIQ Ltd announced the outcomes of its EXO-OC study, which highlighted inconsistent miRNA biomarker levels across different biorepositories, impacting the test's performance. The study revealed that the variability in sample collection, handling, and storage procedures prior to receipt by INOVIQ significantly affected the test's performance. As a result, the samples were unsuitable for a meaningful evaluation of the EXO-OC test. INOVIQ is committed to addressing these issues through a complete technical review, ongoing refinement of biomarkers and algorithm, and sourcing samples from a single-site biobank or through a collaborator, CRO, or partner. The company also plans to progress pre-analytical studies and update analytical and clinical validation studies. Despite these challenges, INOVIQ's commercialization strategy for the EXO-OC test remains unchanged. The management's accountability is under review, and consequences for management will be determined after a full review of the current study.

INOVIQ aims to minimize impact on development and commercialization timelines for EXO-OC

INOVIQ is committed to refining and validating the EXO-OC biomarkers and algorithm, optimizing the development pathway, and progressing discussions with potential partners to support the next phase of development.