（CE-IVD）oncoReveal™ Dx Lung and Colon Cancer Assay

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.

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)

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

Resources

Use Guide