EGFR/ALK/ROS1 Mutations Detection Kit
PCR
Real-time PCR Assays
100%
100%
Accuracy
25 copies/μL
Sensitivity
Features
Selectable
- Convenient pre-loaded format.
1
- Convenient pre-loaded format.
Universal
- Compatible with tissue samples.
2
- Compatible with tissue samples.
Precise
- Top sensitivity of 1% (EGFR), and 125 copies/rxn (ALK/ROS1).
3
- Top sensitivity of 1% (EGFR), and 125 copies/rxn (ALK/ROS1).
Easy
- One-step procedure, results in 120 mins.
4
- One-step procedure, results in 120 mins.
Reliable
- Internal and external controls included.
5
- Internal and external controls included.
Product Description

EGFR/ALK/ROS1Mutations Detection Kit

Detection of 24 EGFR mutations (exons 18-21), 21 ALK gene fusions and 13 ROS1 gene fusions.

EGFR, ALK and ROS1 are the most common molecular targets for targeted therapies in a subset of patients with non-small cell lung cancer (NSCLC). EGFR mutations, ALK and ROS1 gene fusions are shown to be effective therapeutic targets of tyrosine kinase inhibitors (TKIs).

NSCLC patients with sensitizing EGFR mutations are most likely to respond to Iressa (Gefitinib), Tarceva (Erlotinib) or Afatinib (Boehringer Ingelheim). And NSCLC patients with ALK and ROS1 fusions are shown to respond to treatment with Xalkori (Pfizer).

NCCN Clinical Practice Guideline for non-small cell lung cancer clearly indicates that all patients with NSCLC should conduct EGFR mutation testing and ALK testing before TKIs treatment. If both sensitizing EGFR mutation and ALK are negative or unknown, consider ROS1 testing.

The AmoyDx® EGFR/ALK/ROS1MutationsDetection Kit is a one-step real-time PCR test (combined Reverse transcription and PCR amplification) intended for qualitative detection of 24 EGFRmutations (exons 18-21), 21 ALKGene Fusions and 13 ROS1 Gene Fusions.

Technological Principles

The kit contains RNA gene fusion and DNA gene mutation detection system.

The RNA gene fusion detection system uses novel, specific primers and fluorescent probes and combines a one-step RT-PCR procedure, which comprises reverse transcription of target RNA and reference gene RNA to generate complementary DNA (cDNA) and simultaneous PCR amplification of cDNA to detect ALK and ROS1 gene fusions.

The DNA gene mutation detection system uses ADx-ARMS technology, which comprises novel, specific primers and fluorescent probes to detect mutations and reference gene in a real-time PCR assay. The mutant DNA is amplified accurately by the specific primers, and detected by the novel probes. Highly Specific primers and probes, and a highly validated procedure based on Taq DNA polymerase contribute to outstanding assay sensitivity and selectivity.

Testing Procedure
Compatible Sample Types:FFPE Samples
Compatible Real-time PCR Instrument
ABI 7500
LightCycler 480 II
SLAN-96S
Stratagene Mx3000P™
Other Info.

To order, please contact sales@amoydx.com.

AmoyDx EGFR/ALK/ROS1Mutations Detection Kit provides reagents to perform assays for 8 tests:

 Product Name

Type

Size (test/kit)

 Storage

 Cat. No.

EGFR/ALK/ROS1 Mutations Detection Kit

Pre-loaded

8

-20℃

8.01.25501W008A
8.01.25501W008B
8.01.25501W008D


Publications
1. Zhang, Qing, et al. "Prevalence of ROS1 fusion in Chinese patients with non‐small cell lung cancer." Thoracic cancer 10.1 (2019): 47-53.

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