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

Pre-sales consultation

Sign the consent form, collect paraffin-embedded sections

Send the specimen to the laboratory

Analyse the experimental data

A total of 7 working days to complete the report**
**Only applicable to the sample that fulfil the QC requirements.