2028 US Test Validation
INOVIQ Targets 2028 US Ovarian Test Validation Following Independent Review
Anonymous
INOVIQ’s independent review of its OC2200 verification study found that inconsistent blood collection, processing and handling across five biorepositories were the main source of biomarker variability, leaving too little reliable data to assess EXO-OC’s performance across the full cohort. The review affirmed the company’s analysis and found evidence of biological relevance: in samples from one collection site, the test distinguished ovarian cancer from benign gynecological conditions. INOVIQ plans to optimize the assay and biomarker panel, verify performance using a standardized independent cohort, and complete U.S. laboratory validation with a certified partner by the first half of 2028, ahead of potential Laboratory Developed Test commercialization.
Key Points
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OC2200 samples had substantially lower measurable miRNA biomarker levels than those in the earlier OC500 study; many panel measurements were at or beyond the assay’s reliable measurement range or failed to amplify.
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The independent review was conducted by Dr Mathew Moore, principal of US-based contract diagnostics organisation ResearchDx, which recomputed the OC2200 results and found INOVIQ’s technical assessment accurate and reproducible.
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The planned assay optimisation includes improving tumour-specific extracellular-vesicle capture using INOVIQ’s EXO-NET technology and refining the biomarker panel to improve signal-to-noise ratios.
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The company says the review’s pre-analytical problems could only be identified after the OC2200 program was completed, and recommends consistent sample-collection protocols before further clinical evaluation.
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