# CRCDx RAS Mutation Detection Assay Kit

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

## TL;DR

A PCR test that confirms a bowel cancer has no KRAS or NRAS mutation before panitumumab.

## Summary

EntroGen's CRCDx RAS Mutation Detection Assay Kit was approved on 29 September 2023 (PMA P220005) as the companion diagnostic for panitumumab in colorectal cancer, identifying tumours wild-type for KRAS and NRAS in exons 2, 3 and 4. EntroGen describes it as a real-time PCR test.

## Fields

- Kind: Test
- Status: approved
- Last checked: 2026-11-03
- Tags: test
- Brand: CRCdx RAS Mutation Detection
- Modality: Real-time PCR companion diagnostic test (KRAS and NRAS, colorectal tumour tissue)
- Mechanism: Real-time PCR for mutations in exons 2, 3 and 4 of KRAS and NRAS in colorectal tumour tissue; a RAS wild-type result means none were found.
- Approvals: US 2023: KRAS and NRAS wild-type (exons 2, 3 and 4) for panitumumab in colorectal cancer

## Sources

- FDA PMA P220005: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P220005
- 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
- EntroGen: CRCdx RAS Mutation Detection: https://www.entrogen.com/

## 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/)
- technologies: [Companion diagnostics](https://onco.cc/technologies/companion-diagnostic/)
- targets: [KRAS](https://onco.cc/targets/kras/), [NRAS](https://onco.cc/targets/nras/)
- drugs: [Panitumumab](https://onco.cc/drugs/panitumumab/)
- companies: [EntroGen](https://onco.cc/companies/entrogen/)
- terms: [Companion diagnostic](https://onco.cc/terms/companion-diagnostic-term/), [Pathologic complete response (pCR)](https://onco.cc/terms/pcr/)

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