Mutation Test using

	Amino Acid Substitution	*KRAS* DNA Mutation	Detectability (%)
*5% Mutant KRAS* DNA on Plasmid**	p.A11P	GCT >CCT	100
	p.G12Fa	GGT >TTT	0b
	p.G12I	GGT >ATT	100
	p.G12L	GGT >CTT	0
	p.G12N	GGT >AAT	100
	p.G12Y	GGT >TAT	100
	p.G13I	GGC >ATC	100
	p.G13N	GGC >AAC	100
	p.V14I	GTA >ATA	100
	p.G15D	GGC >GAC	100
	p.G15S	GGC >AGC	0c
	p.A59E	GCA > GAA	100
	p.A59G	GCA > GGA	100
	p.A59S	GCA >TCA	100
	p.A59Ta	GCA >ACA	100
	p.G60A	GGT > GCT	100
	p.E62D	GAG > GAT	100
	p.E63K	GAG >AAG	100
	p.G13D	GGC > GAC	100
	p.V14I	GTA >ATA	100
	DNA Insertions and Deletions	*KRAS* DNA Mutation	Detectability (%)
	c.30_31insGGA	GGAGCT > GGAGGAGCT	0
	c.35delG	GGT>G^T	100
	c.36_37insGGT	GGTGGC > GGTGGTGGC	100
	c.187_189delGAG	GGAGT > G^^^T	100
NSCLC FFPETd	Amino Acid Substitution	*KRAS* DNA Mutation	Detectability (%)
	p.G12Fa	GGT >TTT	100
	p.A59Ta	GCA >ACA	100
^aThese plasmids were tested in both the plasmid mixture and in NSCLC FFPET specimens.^bThe p.G12F plasmid blended at 5% with 95% wild-type genomic DNA was not detectable. However, the same plasmid blended at 10% or 15% was detected at 100%.^cThe p.G15S plasmid blended at 5% with 95% wild-type genomic DNA was not detectable. However, the same plasmid blended at 10% or 15% was detected at 100%.^dFive different NSCLC FFPET specimens with the G12F mutation were tested and all 5 showed 100% detectability. One NSCLC FFPET specimen with the A59T mutation was tested and detected 100%.

Table 6: Inclusivity of the cobas®KRAS Mutation Test using 5% mutant KRAS DNA sequences blended with wild-type genomic DNA or FFPET NSCLC samples. The percent of KRAS mutant DNA in the FFPET samples is unknown.