Inoviq alters cancer study after sample setback

• Inoviq altered the clinical development path for its EXO-OC ovarian cancer test after determining that 1,200 biobanked plasma samples were unsuitable due to degradation and quality issues.
• The decision removes an expanded retrospective study as a near-term validation step, forcing the business to rely on a redesigned evaluation pathway for future clinical performance evidence.
• The company stated that it will now target a new study using a single-site nested prospective model or a real-world partner study to evaluate high-risk and confounding disease groups.

Inoviq (ASX:IIQ) has altered its clinical development pathway for the EXO-OC ovarian cancer test after concluding that sample degradation across 1,200 biobanked plasma samples rendered them unsuitable for performance evaluation.

This development contrasts with the company's intended goals for the expanded study, which was designed to evaluate the test across up to 2,000 samples to assess performance across various cancer stages and high-risk groups.

“While study objectives were not achieved, the findings inform our future studies, and the issues are addressable,” said Inoviq Founding Scientist Professor Gregory Rice.

The secondary details reveal that one commercial biorepository supplied 616 samples and 69% of the cancer cases, but these specific samples showed significantly reduced protein and microRNA levels consistent with degradation.

The company stated that the sample quality issues were unrelated to the performance of its underlying technology, and following the announcement, the Inoviq share price was down at $0.56.

The EXO-OC test is an exosome-based blood test in development for early detection and screening of ovarian cancer that utilises the company's proprietary technology to isolate biomarkers.

The business stated that its long-term strategy remains focused on first commercialising the test as a laboratory-developed test in the United States, specifically targeting women at high risk of developing ovarian cancer.