Multi-Gene Mutations Detection Kit
PCR
Real-time PCR Assays
4
Compatible Instrument
9
Driver Genes
118
Mutations/Fusions
45 copies/μL
Sensitivity for Fusion
1%
1%
Sensitivity for Mutation
100%
100%
Accuracy
Features
Simple
- One-step PCR
1
- One-step PCR
Universal
- Validated on most common PCR instruments
2
- Validated on most common PCR instruments
Fast
- Results in 2 hours
3
- Results in 2 hours
Objective
- Result interpretation by Ct value
4
- Result interpretation by Ct value
High-sensitivity
- 1% for DNA and 450 cp/rxn for RNA
5
- 1% for DNA and 450 cp/rxn for RNA
Product Description

 Multi-Gene Mutations Detection Kit
Detection of 118 hotspot mutations/fusions in EGFR/ KRAS/ BRAF/ NRAS/ HER2/ PIK3CA/ ALK/ ROS1/RET genes.
Patients with NSCLC often harbor driver mutations in multiple oncogenes, including EGFR, ALK, ROS1, BRAF, HER2, RET, etc. The presence of gene alterations can impact the selection of and the response to targeted therapies. Testing of lung cancer for multi-gene mutations is important for identification of potentially efficacious targeted therapies. Therefore, identifying mutations in oncogenes and tailoring therapy accordingly are widely accepted in clinical cancer management. Faster detection of driver mutations enables quicker initiation of proper therapy.
AmoyDx Multi-Gene Mutations Detection Kit is a real-time PCR assay for detection of 118 hotspot mutations/fusions in 9 driver genes (EGFR, KRAS, BRAF, NRAS, HER2, PIK3CA, ALK, ROS1 and RET genes) in NSCLC at a time from a single tissue specimen.

Technological Principles
The assay contains mRNA-based fusion detection and DNA-based mutation detection.
The RNA gene fusion detection system uses specific primers and fluorescent probes which are designed for both side genes of the fusion, combining a one-step RT-PCR procedure to detect ALK, ROS1 and RET gene fusions based on tumor message RNA. The protocol comprises reverse transcription of target RNA and reference gene RNA to generate complementary DNA (cDNA) and simultaneous PCR amplification of resulting cDNA.
The DNA gene mutation detection system uses ADx-ARMS technology, which comprises specific primers and fluorescent probes to detect mutations in EGFR, KRAS, BRAF, NRAS, HER2, and PIK3CA genes. During the amplification, the target mutant DNA is matched with the bases at 3’ end of the primer, and amplified efficiently, then the mutant amplicon is detected by fluorescent-labeled probes. While the wild-type DNA cannot be matched with specific primers, there is no amplification occurs.

Testing Procedure
Compatible Sample Types:FFPE tissue
Compatible Real-time PCR Instrument
ABI7500
SLAN-96S
Mx3000P
LightCycler 480 II
Cobas z480
Other Info.

To order, please contact sales@amoydx.com.
AmoyDx Multi-Gene Mutations Detection Kit is available in the following size.

Product Name  Size (tests/kit)  Storage  Cat. No.
AmoyDx Multi-Gene Mutations Detection Kit (Pre-loaded) 6T -20℃ 8.01.26301W006A
8.01.26301W006B
8.01.26301W006D
8.01.26301W006J


Publications
1. Lu, Shan, et al. "Comparison of EML4-ALK fusion gene positive rate in different detection methods and samples of non-small cell lung cancer." Journal of Cancer 11.6 (2020): 1525.

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