Table 2.

DKK1 RNAscope digital image analysis validation results.

Performance parametera	Tumor resections evaluated (n)	Percentage pass	Parameter pass/fail
Analytical specificityb	40	90% (36/40)	Pass
Analytical sensitivityc	40	100% (40/40)	Pass
Accuracyd	36	r = 0.74, p value < 0.0001	Pass
Precisione	12	92% (11/12)	Pass

^aDetails of the pre-defined acceptance criteria are described in the methods.

^bAlgorithm accurately identified cells as objects, accurately classified tumor and stromal compartments of the tissue, and accurately classified DKK1 negative cells.

^cAlgorithm accurately identified cells when present and classified DKK1 positive cells correctly.

^dPearson correlation (p value < 0.05) with DKK1 manual H-scores.

^eResults across 3 separate staining days within the same binned category of expression (negative bin: H-score = 0, low bin: H-score < 34, and high bin: H-score ≥ 35). In cases of discordant binning of negative, low or high categories, a ± 20 point H-score discrepancy was still considered acceptable.