Table 4.

Number and Percentages of Discrepant Samples by Category^a

Reasons for Discrepancy (All Mutations)	No. of Discrepant Individual Mutations (n = 91)	No. (%) of Discrepant Samples (n = 86)	% of Discrepant Samples in the Concordance Data Set (n = 850)
Mutations not in Idylla cartridge	32	29 (33.7)	3.4
Biomarker not run as SOC or not in SOC panel	14	14 (16.3)	1.6
Biomarkers run as SOC but discrepant; unknown	9	9 (10.5)	1.1
Discrepant (false) positives	15	15 (17.4)	1.8
Discrepant (false) negatives	6	6 (7.0)	0.7
Sensitivity (SOC or Idylla technology)	7	7 (8.1)	0.8
Possible variant cross-reactivity or identified in Idylla Explore software	8	6 (7.0)	0.7
Total discrepant results			10.1

SOC, standard of care.

^aDiscordant samples were categorized as mutations not included in the Idylla cartridge by design, false positives, false negatives, sensitivity related where there were borderline results that were either close to assay cutoffs or not detectable due to technology limitations, variant cross-reactivity where genetic sequences were close together in the genome and identified different mutation variants but provided the same clinical result, and unknown or undetermined reasons. In the 850-sample data set, there were 91 instances of discordance within 86 samples. The additional five instances of discordance were due to double mutations detected in samples. For example, a double mutation could refer to both a KRAS Q22K mutation and a BRAF D594G mutation present in a sample and detected by SOC next-generation sequencing but not by Idylla.