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Human Oncology Multi-Gene Mutations Detection Kit

Human Oncology Multi-Gene Mutations Detection Kit

Next Generation Sequencing

CE-IVD Certificate no.No.MDD-SZ-XW-160321

For scientific research use in China


Gene Mutation and Tumor

Tumor is the neoplasm of normal tissue, of which cancer is malignant neoplasm driven by various of tumorigenesis factors. Gene mutations caused by environment and heredity (including point mutation, deletion, insertion, copy number increase, gene fusion and so on) may lead to the division and growth of normal cells out of control and finally induce the formation of tumors.


Targeted drugs are able to target the pathologic molecules in cancer cells caused by specific gene mutations, which will maximize the drug efficacy and minimize the side effects. Therefore, the detection of the patient's gene status can contribute the clinicians to select suitable target drugs.


The initiation of the tumor is usually caused by activation proto-oncogenes or inactivation suppressor oncogenes. Studies had shown that 87% of Asian patients with lung adenocarcinoma have carried known kinds of driver genes mutations, 81% of which had clear target inhibitors, thus, 66% of patients can be treated with personalized target treatments.



                           



Detection significance

 •  Assist clinicians to select targeted drugs for patients.

 •  Predict efficacy and resistance of targeted drugs.


Detected Genes


No.NameGene TypeCovered ExonsNumber of Mutations
1EGFRDNA18,19,20,21102
2KRAS2,3,456
3BRAF1541
4PIK3CA10,14,2151
5NRAS2,332
6HER219,20,2116
7MET2,14,16,19,2011
8AKT121
9c-KIT9,11,13,17100
10PDGFRA12,1821
11ALKRNAFusion mutation21
12RETFusion mutation15
13ROS1Fusion mutation15


Performance Parameter

 

Product 

Name

Core

Technology

Product

Specification

Matched 

Instrument

Sample Requirement
Sample TypeQuantity

Storage

Conditions

Human Oncology

Multi-Gene

Mutations

Detection Kit

RingCap®

16 tests/kit or 

32 tests/kit

Ion Torrent,

Illumina

FFPE Tissue

10 sections

5-10 μm

room temperature 
ctDNA,peripheal blood RNA10mL4℃
pleural effusion30-50mL4℃



Advantages and Characteristics


Easy Operation: With independent patented RingCap® technology, library construction can be done in only two steps.

Rapid Detection: Library construction takes only 3.5 hours, only 5 working days from sample processing to reporting.

High Sensitivity:20000x sequencing depth. Up to 0.1% of sensitivity. Achieving the drug resistance monitoring for the liquid biopsy samples.

Comprehensive Detection: Detecting 13 mutated genes, covering 482 existing targeted drug-related COSMIC loci in one time. Comprehensive analysis the genetic information of non-small cell lung cancer andcolorectal cancer. To guide the use of targeted drugs which is recommended by the domestic andforeign authoritative institutions.




Detection Process