Colorectal Cancer Related Gene Mutation Detection Kit
Next Generation Sequencing;CE-IVD
Colorectal Cancer Related Gene Mutation Detection Kit
Ensure that patients with colorectal cancer receive the most appropriate treatment.
GENE MUTATION AND TUMOR


Colorectal cancer (CRC) ranks third in global cancer incidence and second in cancerrelated mortality. CRC management involve surgery, chemotherapy, radiotherapy, imaging, pathology, and endoscopy. Systemic medical therapy is a critical component, and gene testing prior to treatment is recommended to guide targeted therapy.


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PRODUCT INFORMATION

The kit covers the common molecular detection markers for colorectal cancer,MSI, KRAS, NRAS, BRAF V600E, HER2 amplification, UGT1A1/DPYD variants, PIK3CA hotspot regions, and TP53 coding regions.

PROJECT PARAMETER
Project
Core Technology
Packing Specification
Compatible Platforms
Specimen Material
Colorectal Cancer Related Gene Mutation Detection Kit
RingCap®
16 Tests/Kit ;32 Tests/Kit
Platform-agnostic, compatible with Illumina, MGI and more sequencers
Tumor tissue, Ascites
TARGET POPULATION

1.Resectable nonmCRC patients – testing before adjuvant chemotherapy aids in regimen selection;

2.Unresectable nonmCRC patients – testing before treatment decision guides conversion or palliative therapy options;

3.All mCRC patients – testing before comprehensive treatment to tailor therapy based on RAS/BRAF and MSI status;

4.mCRC patients refractory to standard therapy – testing to identify suitable targeted or immunotherapeutic agents;

5.Patients clinically suspected of Lynch syndrome – testing for Lynch screening.

CLINICAL SIGNIFICANCE

1. RAS, BRAF, HER2 mutation status – guides use of EGFR monoclonal antibodies, BRAF/MEK inhibitors, HER2 inhibitors, and provides prognostic information for CRC.

2. UGT1A1 and DPYD – guides irinotecan, 5-FU, capecitabine, and tegafur dosing.

3. MSI testing – predicts response to immune checkpoint inhibitors.

4. MSI and BRAF V600E – indicate Lynch syndrome risk.


FEATURES & ADVANTAGES
Comprehensive Coverage

Comprehensive Coverage

Covers mandatory genes recommended by CRC guidelines and consensus, along with selected optional genes and MSI status

MSI Status Testing

MSI Status Testing

Employs 34 mononucleotide repeat markers, effectively eliminating polynucleotide polymorphism interference and enabling singlesample (tumoronly) testing

High Sensitivity

High Sensitivity

Identifies mutations down to 1% VAF within 25 ng DNA

Simple Operation

Simple Operation

Based on the independent patent technology RingCap®, requiring only two steps for library construction

DETECTION PROCESS

1. Nucleic Acid Extraction

2. Library Preparation (3.5 hours total time)

3. Sequencing

4. Auto-data Analysis

5. Report