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

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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

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

Table 2: List of Variants with Established Analytical Performance Only

GENEVariant IDCancerNucleotide Change
EGFRT790MNSCLCc.2369C>T
EGFRG719ANSCLCc.2156G>C
EGFRG719CNSCLCc.2154_2155delinsTT;
c.2155G>T
EGFRG719DNSCLCc.2156G>A
EGFRG719SNSCLCc.2155G>A
EGFRExon 20 In-frame
Insertions
NSCLCMultiple
BRAFV600ENSCLC
c.1799T>A;
c.1799_1800delinsAA
KRASExon 2 MutationNSCLCMultiple
KRASA59ECRCc.176C>A
KRASA59GCRCc.176C>G
KRASA59TCRCc.175G>A
KRASA59SCRCc.175G>T
KRASQ61ECRCc.181C>G
KRASQ61HCRCc.183A>C ; c.183A>T
KRASQ61KCRCc.180_181delinsAA ;
c.180_181inv ; c.181C>A
KRASQ61LCRCc.182A>T ; c.182_183delinsTC
; c.182_183delinsTG ;
c.182_183inv
KRASQ61RCRCc.182A>G ; c.182_183delinsGC ;
c.182_183delinsGT
KRASK117NCRCc.351A>C ; c.351A>T
KRASA146TCRCc.436G>A
KRASA146PCRCc.436G>C
KRASA146VCRCc.437C>T
BRAFV600ECRCc.1799T>A ;
c.1799_1800delinsAA


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