Table 1.

Guideline-recommended biomarker status by comprehensive ctDNA and SOC tissue testing

Primary analysis population (N = 155)a
		Tissue				ctDNA to tissue, %	Tissue to ctDNA, %
		Positive	Negative	Total	PPA	87.8	81.8
ctDNA	Positive	72	16	88	PPV	81.8	87.8
	Negative	10	57	67	NPA	78.1	85.1
	Total	82	73	155	NPV	85.1	78.1
					OPA	83.2	83.2

Secondary analysis population (N = 118)b
		Tissue				ctDNA to tissue, %	Tissue to ctDNA, %
		Positive	Negative	Total	PPA	89.6	85.7
ctDNA	Positive	60	10	70	PPV	85.7	89.6
	Negative	7	41	48	NPA	80.4	85.4
	Total	67	51	118	NPV	85.4	80.4
					OPA	85.6	85.6

Biomarkers included are KRAS SNVs, NRAS SNVs, BRAF V600E, MSI-H, and ERBB2 CNVs.

ctDNA, circulating tumor DNA; NPA, negative percent agreement; MSI, microsatellite instability; NPV, negative predictive value; OPA, overall percent agreement; PPA, positive percent agreement; PPV, positive predictive value; SNV, single-nucleotide variant; SOC, standard of care.

^aSamples that were negative, in which testing failed, which had no detectable tumor, or were not assessed for all biomarkers of interest are classified as ‘negative’.

^bSecondary analysis population excludes samples in which testing failed, which had no detectable tumor, were not assessed for biomarkers of interest (N = 12), or samples where tissue was taken >20 days prior to stage IV diagnosis (N = 25).