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PRODUCTS

Oncology Multi-Gene Mutations Detection Kit

Lunybo®

(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 gain, 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 targeted 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
8AKT12
9KIT9,11,13,17
10PDGFRA12,18
11ALKRNA  Fusion MutationEML4-ALK(21kinds)
12RET

KIF5BCCDC6NCOA4PCM1GOLGA5

HOOK3KTN1(15 kinds)

13ROS1

CD74GOPCSDC4SLC34A2EZRLRIG3

TPM3-ROS1(15 kinds)

14MET
 Skipping Mutation14 Exon skipping mutation



PRODUCT INFORMATION


Product NameCore Technology  Pack Size

Instruments Validated

Sample Type

Lunybo®

Oncology Multi-Gene 

Mutation Detection Kit

RingCap®

16 Tests/Kit

32 Tests/Kit

Ion Torrent,

Illumina

MGISEQ

Tumor tissue,

Peripheral blood,

Pleural effusion


DETECTION SIGNIFICANCE


Personalized treatment:Select suitable targeted 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.

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 three NGS platforms: Ion Torrent, Illumina and MGISEQ.



DETECTION PROCESS 


1.Nucleic Acid Extraction

2.Library Preparation (3.5 hours total time)

3.Sequencing

4.Auto-data Analysis

5.Report