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Top-Line Results of the Phase 3 ZIRCON Study

Panelists discuss how the ZIRCON trial results showed impressive test characteristics with 95% positive predictive value for clear cell renal cell carcinoma, meaning a positive test strongly indicates cancer requiring treatment.

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      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.

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