Table 2.

Clinical validation study: prognostic test performance of the 8-biomarker assay against the two coprimary endpoints

Population (N)Endpoint definitionAUC (95% CI)P (Bonferroni-adjusted)OR lowest- to highest-risk score quartile (95% CI)OR as point estimate for continuous range of risk scores (95% CI)
Coprimary endpoints
(N = 274)aFavorable pathology—Surgical Gleason ≤3+4 and organ confined (≤T2) vs. nonfavorable—surgical Gleason ≥ 4+3 or non-organ confined (T3a, T3b, N, or M)0.68 (0.61–0.74)<0.00013.3 (1.8–6.1)20.9 (6.4–68.2)
(N = 276)“GS 6”—Surgical Gleason = 3+3 and localized ≤T3a vs. “non–GS 6”—surgical Gleason ≥3+4 or nonlocalized (T3b, N, or M)0.65 (0.58–0.72)<0.00014.2 (1.9–9.3)12.6 (3.5–47.2)
  • aTwo patient samples (of 276) lacked sufficient annotation for this calculation.