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 cobasĀ®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.