Human Pan-Cancer Drive Gene Mutations Detection Kit
Next Generation Sequencing; CE-IVD
Human Pan-Cancer Drive Gene Mutations Detection Kit
Individualized medication: Selecting patients with non-small cell lung cancer, colorectal cancer, gastrointestinal tumors and some solid & hematologic tumors to targeted therapy; results for targeted drug matching, drug resistance monitoring and prognosis evaluation.
GENE  MUTATION AND TUMOR



Pan-solid tumor driver gene mutation detection covers companion diagnostic genes approved by the FDA and recommended by NCCN Guidelines. This assay includes 56 genes associated with treatment and prognosis, covering 3,000 COSMIC variants, and delivers cost-effective, high-sensitivity, high-throughput testing for solid tumor tissue and circulating cell-free DNA samples.

Cancer is a complex polygenic disorder resulting from stepwise accumulation of genetic mutations. Alterations in growth-regulating genes cause uncontrolled cell proliferation and differentiation, driving malignant tumor development.


GENE  MUTATION AND TUMOR
DETECTED TARGETS


DNA:Detects single nucleotide variants (SNVs) and small insertion-deletion variants (InDels) across 50 genes.

RNA:Detects 6 gene fusions (ROS1, ALK, RET, NTRK1, NTRK2, NTRK3) and MET exon 14 skipping mutations.

AMP:HER2 and MET gene amplification status.


PRODUCT INFORMATION
Product Name
Technology
Packing Specification
Compatible Platform
Specimen Material
Human Pan-Cancer Drive Gene Mutations Detection Kit
NGS(RingCap® Library Preparation)
16 Tests/Kit;32 Tests/Kit
Platform-agnostic, compatible with Illumina, Ion Torrent, MGI and more sequencers
Tumor tissue,eripheral Tumor tissue samples, peripheral blood, pleural & ascitic fluid
DETECTION SIGNIFICANCE 

Applicable to patients with a variety of solid tumors and select hematological malignancies. This assay primarily evaluates drug sensitivity and prognosis for cancer patients receiving targeted therapy, assisting clinicians in selecting appropriate targeted agents and enabling comprehensive guidance on systemic treatment strategies. It also delivers partial hereditary-related genomic information to assess familial cancer risks.

FEATURES & ADVANTAGES
Easy Operation

Easy Operation

Powered by proprietary patented RingCap® technology. Library preparation is completed in only two steps, with a theoretical turnaround time of 3.5 hours

Rigorous QC

Rigorous QC

Strict quality control is implemented throughout the entire workflow, from sample collection, nucleic acid extraction, library construction, sequencing and data analysis to report issuance, to guarantee test accuracy

High Sensitivity

High Sensitivity

Capable of detecting gene mutations with variant frequency as low as 1% from 10 ng DNA; identifies fusion variants at concentrations down to 20 copies/μL in RNA samples

Comprehensive Detection

Comprehensive Detection

Simultaneous DNA+RNA testing covers 3,000 COSMIC variants, reducing missed calls and maximizing therapeutic options

DETECTION PROCESS 

1. Nucleic Acid Extraction

2. Library Preparation

3. Sequencing

4. One-stop Data Analysis

5. Report Generation