Top-Line Results of the Phase 3 ZIRCON Study

Diagnostic Performance of the ZIRCON Trial

Main Discussion Topics:

• A 93% to 95% positive predictive value for clear cell renal cell carcinoma (ccRCC)
• A 75% negative predictive value
• Important observation that non–clear cell positive cases were still malignant
• A positive test indicates cancer with high probability.

Key Points for Physicians:

• When the test is positive, there is a greater than 90% probability of ccRCC.
• The 7% of positive tests that weren’t ccRCC were still malignant tumors.
• A positive test strongly supports proceeding with intervention.
• A simplified interpretation: If it lights up, it’s very likely cancer.

Notable Insights:

A key clinical value is that a positive test is highly reliable for indicating malignancy, even in the small percentage that aren’t specifically ccRCC.

Clinical Significance:

The high positive predictive value provides actionable information that can guide clinical decision-making toward appropriate intervention.