Home·Explore by Test·CRCDx RAS Mutation Detection Assay Kit
FDA-approved companion diagnostic

CRCDx RAS Mutation Detection Assay Kit

Real-time PCR assay that detects KRAS and NRAS exon 2–4 mutations in FFPE colorectal cancer tissue to help identify patients eligible for RAS wild-type–directed therapy.

IVD-developed CDxMethod: PCRSpecimen: Tissue (FFPE)Biomarker: KRAS, NRAS
Ready to order?

Casandra.ai provides a unified ordering experience so you can request this test directly from the performing lab, without changing your workflow.

Ordering is available where Casandra has an active integration with the performing lab. Labs that offer this test can connect with us to enable digital ordering.

About this test

FDA approval details
PMA number
P220005
Supplements
Manufacturer
EntroGen, Inc.
Approval date
September 29, 2023
Test specifications
Methodology
PCR
Specimen
Tissue (FFPE)
Report format
Comprehensive report PDF
Turnaround (typical)
Not specified
Biomarker(s)
KRAS, NRAS
What this test is

CRCDx RAS Mutation Detection Assay Kit is an FDA-approved, qualitative real-time PCR test that detects 35 KRAS and NRAS exon 2, 3, and 4 mutations in genomic DNA from FFPE colorectal cancer tissue. Run on the QuantStudio Dx instrument with dedicated analysis software, it reports mutation detected or not detected to help determine RAS mutation status and support selection of appropriate therapy.

Where this test fits

IndicationBiomarkerBiomarker detailsTherapy (Select a therapy to open its FDA-approved testing pathway)
Colorectal Cancer (CRC)KRAS and NRASwild-type (absence of mutations in exons 2, 3 and 4)VECTIBIX

IVD Manufacturer

EntroGen, Inc.

EntroGen is a leading biotechnology firm offering end-to-end solutions in molecular diagnostics for oncology and hematology by providing automation, reagents, and software. Starting from automated nucleic acid extraction and culminating in genomic interpretation with its proprietary software embedded throughout the entire workflow, EntroGen solutions are designed to be accurate, economical, and scalable.

Order this test

If your organization is connected to Casandra, you can place an electronic order forCRCDx RAS Mutation Detection Assay Kit directly from your existing workflow.

Casandra connects providers, labs, and sponsored programs so that companion diagnostics can be ordered consistently and documented cleanly, regardless of which system you start from.

CDxTests.com is an informational resource for providers. Always refer to the official FDA labeling and laboratory documentation when making treatment decisions.

© 2025 Casandra.ai

CRCDx RAS Mutation Detection Assay Kit - CDxTests.com | CDx Tests