Inoviq Announces EXO-OC Technical Review and Path Forward
Key points
- Independent review confirmed pre-analytical sample issues as key study variability source
- Recommendations to optimize EXO-OC test for better performance
- Company outlines staged program for US LDT commercialization by H1 CY2028
Full summary
Inoviq Limited announced the completion of an independent technical review of the OC2200 study, which was unable to be completed due to variability in biorepository samples. The review confirmed pre-analytical sample collection and handling differences as the largest source of study variability. The independent reviewer recommended optimizing the EXO-OC test to increase the signal-to-noise ratio, refine the biomarker panel, and implement consistent sample collection protocols. The company has established a staged optimization, verification, and laboratory validation program targeting US Laboratory Developed Test commercialization within 12-18 months, aiming for H1 CY2028.
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