# ONCO/Reveal Dx Lung and Colon Cancer Assay

Source: https://onco.cc/drugs/onco-reveal-dx-lung-colon/  
OnCo record `onco-reveal-dx-lung-colon` (Test). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A sequencing test that confirms KRAS is unmutated before cetuximab or panitumumab in bowel cancer, and finds common EGFR mutations in lung cancer.

## Summary

Pillar Biosciences' ONCO/Reveal Dx Lung & Colon Cancer Assay was approved on 30 July 2021 (PMA P200011). In colorectal cancer it identifies KRAS wild-type tumours (no mutation in codons 12 and 13) for cetuximab or panitumumab. In non-small-cell lung cancer it carries a group claim: EGFR exon 19 deletions or L858R for any tyrosine kinase inhibitor the FDA has approved for that use, which the FDA list names as erlotinib, osimertinib, gefitinib, afatinib, dacomitinib and lazertinib (as part of a combination).

## Fields

- Kind: Test
- Status: approved
- Last checked: 2026-11-03
- Also known as: ONCO/Reveal Dx Lung & Colon Cancer Assay; O/RDx-LCCA
- Tags: test
- Brand: ONCO/Reveal Dx Lung & Colon Cancer Assay
- Modality: Tissue NGS companion diagnostic test (KRAS and EGFR)
- Mechanism: Next-generation sequencing of tumour tissue for KRAS codon 12 and 13 mutations in colorectal cancer and EGFR exon 19 deletions or the exon 21 L858R mutation in lung cancer.
- Approvals: US 2021: KRAS wild-type for cetuximab or panitumumab in colorectal cancer; EGFR exon 19 deletion or L858R for approved EGFR inhibitors in NSCLC (group labelling)

## Sources

- FDA PMA P200011: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200011
- FDA: List of cleared or approved companion diagnostic devices: https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools

## Connected records

- biomarkers: [RAS wild-type (extended KRAS and NRAS testing)](https://onco.cc/biomarkers/ras-wild-type/)
- cancers: [Colorectal cancer](https://onco.cc/cancers/colorectal/), [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/)
- technologies: [Companion diagnostics](https://onco.cc/technologies/companion-diagnostic/)
- targets: [EGFR](https://onco.cc/targets/egfr/), [KRAS](https://onco.cc/targets/kras/)
- drugs: [Afatinib](https://onco.cc/drugs/afatinib/), [Cetuximab](https://onco.cc/drugs/cetuximab/), [Dacomitinib](https://onco.cc/drugs/dacomitinib/), [Erlotinib](https://onco.cc/drugs/erlotinib/), [Gefitinib](https://onco.cc/drugs/gefitinib/), [Lazertinib](https://onco.cc/drugs/lazertinib/), [Osimertinib](https://onco.cc/drugs/osimertinib/), [Panitumumab](https://onco.cc/drugs/panitumumab/)
- companies: [Pillar Biosciences](https://onco.cc/companies/pillar-biosciences/)
- terms: [Companion diagnostic](https://onco.cc/terms/companion-diagnostic-term/), [Next-generation sequencing (NGS)](https://onco.cc/terms/ngs/)

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