ONCO/Reveal™
Dx Lung and Colon Cancer Companion Diagnostic Test

What is Dx Lung and Colon Cancer Companion Diagnostic Test?

It is a next generation sequencing based test for detection of somatic mutations in DNA derived from formalin-fixed paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) and colorectal cancer (CRC) tumor tissue.

The test is intended to be used to select patients with NSCLC or CRC that may benefit from treatment with the targeted therapies listed in Table 1 in accordance with the approved therapeutic product labeling.

Table 1. List of Somatic Variants for Therapeutic Use

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)

The majority of lung cancers (~85%) are classified as non-small cell lung cancer (NSCLC).[4] Nearly half of NSCLC cases are associated with point mutations, or other biomarkers such as EGFR. The prevalence of these biomarkers varies between ethnic populations. The proportion of EGFR mutations is much higher in NSCLC patients in Asia (30-40%) than in NSCLC patients in the US and Europe (10-15%).[1]

non-small cell lung cancer (NSCLC)

85%

35-40% of patients with CRC found activating mutations in KRAS

10-15%

The proportion of EGFR mutations

30-40%

[1] Ellison, G., Zhu, G., Moulis, A., Dearden, S., Speake, G., & McCormack, R. (2012). EGFR mutation testing in lung cancer: a review of available methods and their use for analysis of tumour tissue and cytology samples. Journal of Clinical Pathology, 66(2), 79–89. https://doi.org/10.1136/jclinpath-2012-201194

An approximation of 35-40% of patients with CRC found activating mutations in KRAS. Therefore, KRAS-mutation status can be a predictive biomarker for response to anti-EGFR-targeted therapy. There is now strong evidence that cetuximab and panitumumab are effective to patients with CRC whose tumours carry a wild-type KRAS gene. [2]

Patients with CRC found activating mutations in KRAS

35-40%

[1] Ellison, G., Zhu, G., Moulis, A., Dearden, S., Speake, G., & McCormack, R. (2012). EGFR mutation testing in lung cancer: a review of available methods and their use for analysis of tumour tissue and cytology samples. Journal of Clinical Pathology, 66(2), 79–89. https://doi.org/10.1136/jclinpath-2012-201194

Target

Confirm whether NSCLC / CRC patients get KRAS or EGFR mutation

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 Inframe 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
Items
Dx Lung and Colon Cancer Companion Diagnostic Test
Content
KRAS wild type (absence of mutations in codons 12 and 13)
EGFR Exon 19 In Frame Deletions and Exon 21 L858R Substitution Mutations
BRAF V600E mutation
Sequencing Platform
NGS
Sequencing Type
Amplicon based sequencing
Variants Type
clinically actionable SNVs, indel
Sample Type
FFPE
TAT
7 working days**

Workflow

STEP 01
STEP 01

Pre-sales consultation

STEP 02
STEP 02

Sign the consent form, collect paraffin-embedded sections

STEP 03
STEP 03

Send the specimen to the laboratory

STEP 04
STEP 04

Analyse the experimental data

STEP 05
STEP 05

A total of 7 working days to complete the report**

**Only applicable to the sample that fulfil the QC requirements.

Scroll to Top