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Oncology Multi-Gene Mutations Detection Kit

 (High Throughput Sequencing)

CE-IVD ,NMPA

Gene Mutation and Tumor

Tumor is a neoplasm formed by the proliferation of local tissue cells under the action of internal and external tumor-causing factors in the body.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.


                           

                        Seo JS, et al. Genome Res 2012;22:2109-2119.


Detected Genes


No.GENENucleic Acid TypeMutation TypeCovering Exons
1EGFRDNAGene Mutation 18,19,20,21
2KRAS2,3,4
3BRAF15
4PIK3CA10,14,21
5NRAS2,3
6HER219,20,21
7MET2,14,16,19
8AKT13
9KIT9,11,13,17
10PDGFRA12,18
11ALKRNA  Fusion MutationEML4-ALK(21kinds)
12RET

KIF5BCCDC6NCOA4PCM1GOLGA5HOOK3

  KTN1(15 kinds)

13ROS1

CD74GOPCSDC4SLC34A2EZRLRIG3

TPM3-ROS1(15 kinds)

14MET
 Skipping Mutation14 exon skipping mutation


Performance Parameter

 

Product NameCore Technology Product Specification

Compatible Instrument

Sample Type

Human Oncology Multi-

Gene Mutation Detection Kit

RingCap®

16Test / box

32Test / bo

Ion Torrent,

Illumina

Tumor tissue ,

Peripheral blood,

Pleural effusion



Detection Significance


Personalized Treatment:Select suitable target drugs for the patients based on the gene detection information to improve the efficacy of the drugs, thus realize personalized treatment.


Monitoring drug efficacy and resistance: Analyze the drug resistance mechanism, adjust the treatment plan according to the gene variation information after drug resistance.


Advantage Characteristics

Simple Operation: Based on the independent patent technology RingCap®, library construction can be finished in only 2 steps.

Rapid Detection: The library construction takes only 3.5 hours, only 2 working days from sampling to reporting.

High Sensitivity: With 10000x sequencing depth, the sensitivity can reach up to 0.1%.

Comprehensive Detection: 13 genes can be detected at one time.

Multiple Instruments: Applicable to both IonTorrent and IIIumina.

Multi-sample: Applicable to tumor tissue, peripheral blood, Pleural effusion.


Detection Process