One assay for six lung and colon cancer therapies

The oncoReveal Dx Lung and Colon Cancer Assay detects somatic mutations
in DNA derived from formalin-fixed paraffin-embedded (FFPE) non-small cell
lung cancer (NSCLC) and colorectal cancer (CRC) tumor tissue. This robust
NGS assay is intended to be used to select patients with NSCLC or CRC that
may benefit from treatment with targeted therapies.

Table 1: Intended Uses

Indication Gene Variant Targeted therapy
Colorectal
Cancer (CRC)
KRAS
KRAS wild-type
(absence of mutations
in codons 12 and 13)
Erbitux (cetuximab), or
Vectibix (panitumumab)
Non-Small Cell
Lung Cancer
(NSCLC)
EGFR
Exon 19 Deletions
Exon 21 L858R
Tarceva (erlotinib),
Gilotrif (afatinib),
Iressa (gefitinib), or
Vizimpro (dacomitinib)

Table 2: List of Variants with Established Analytical Performance Only

Gene Variant ID Cancer Nucleotide Change
EGFR
T790M
NSCLC
c.2369C>T
EGFR
G719A
NSCLC
c.2156G>C
EGFR
G719C
NSCLC
c.2154_2155delinsTT;
c.2155G>T
EGFR
G719D
NSCLC
c.2156G>A
EGFR
G719S
NSCLC
c.2155G>A
EGFR
Exon 20 In-frame
Insertions
NSCLC
Multiple
BRAF
V600E
NSCLC
c.1799T>A;
c.1799_1800delinsAA
KRAS
Exon 2 Mutation
NSCLC
Multiple
KRAS
A59E
CRC
c.176C>A
KRAS
A59G
CRC
c.176C>G
KRAS
A59T
CRC
c.175G>A
KRAS
A59S
CRC
c.175G>T
KRAS
Q61E
CRC
c.181C>G
KRAS
Q61H
CRC
c.183A>C ; c.183A>T
KRAS
Q61K
CRC
c.180_181delinsAA ;
c.180_181inv ; c.181C>A
KRAS
Q61L
CRC
c.182A>T ; c.182_183delinsTC
; c.182_183delinsTG ;
c.182_183inv
KRAS
Q61R
CRC
c.182A>G ; c.182_183delinsGC ;
c.182_183delinsGT
KRAS
K117N
CRC
c.351A>C ; c.351A>T
KRAS
A146T
CRC
c.436G>A
KRAS
A146P
CRC
c.436G>C
KRAS
A146V
CRC
c.437C>T
BRAF
V600E
CRC
c.1799T>A ;
c.1799_1800delinsAA