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PRODUCTS
(Next Generation Sequencing)
CE-IVD ，NMPA
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.
Seo JS, et al. Genome Res 2012;22:2109-2119.
DETECTED GENES
| No. | GENE | Nucleic Acid Type | Mutation Type | Covering Exons |
| 1 | EGFR | DNA | Gene Mutation | 18,19,20,21 |
| 2 | KRAS | 2,3,4 | ||
| 3 | BRAF | 15 | ||
| 4 | PIK3CA | 10,14,21 | ||
| 5 | NRAS | 2,3 | ||
| 6 | HER2 | 19,20,21 | ||
| 7 | MET | 2,14,16,19 | ||
| 8 | AKT1 | 3 | ||
| 9 | KIT | 9,11,13,17 | ||
| 10 | PDGFRA | 12,18 | ||
| 11 | ALK | RNA | Fusion Mutation | EML4-ALK(21kinds) |
| 12 | RET | KIF5B、CCDC6、NCOA4、PCM1、GOLGA5、 HOOK3、KTN1(15 kinds) | ||
| 13 | ROS1 | CD74、GOPC、SDC4、SLC34A2、EZR、LRIG3、 TPM3-ROS1(15 kinds) | ||
| 14 | MET | Skipping Mutation | 14 Exon skipping mutation |
PRODUCT INFORMATION
| Product Name | Core Technology | Pack Size | Instruments Validated | Sample Type |
Oncology Multi-Gene Mutation Detection Kit | RingCap® | 16 Tests/Kit 32 Tests/Kit | 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.
CLINICAL DATA
The total coincidence rate of the two methods for detecting genes was 99.92%
FEATURES & ADVANTAGES
1.Ease of Use:Based on the independent patent technology RingCap®, library preparation in 2 steps.
2.Fast Results:The library preparation takes only 3.5 hours, 2 working days from sampling to reporting.
3.High Sensitivity:Tissue sequencing depth up to 5000X, cell-free DNA sequencing depth up to 20,000X, sensitivity up to 0.1%.
4.Comprehensive Coverage:Covers and detect relevant hotspot mutations in 13 genes, applicable for non-small cell lung cancer, colorectal cancer, malignant melanoma, gastrointestinal stromal tumor.
5.Multiple Instruments: Reagents are compatible with Illumina® NextSeq 500, MiniSeq, and MiSeq and Ion Torrent PGMS5,Proton sequencers.
DETECTION PROCESS
1.Nucleic Acid Extraction
2.Library Preparation （3.5 hours total time）
3.Sequencing
4.Auto-data Analysis
5.Report
Company Name:
XIAMEN SPACEGEN CO.,LTD
Address Of The Company:
NO.2041,XizhouRoad,Xike Town,
Tong'an District,Xiamen City,
Fujian Province, China
Contact Information:+86-592-7578317
Postal Code : 361100
spacegen@ispacegen.com
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