ROS1 Gene Fusions Detection Kit

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Amoy Diagnostics Co.,Ltd.

Business Type:Manufacturer

Country/Region:China

Ddu Verified

HOT Rank

6/10

Product Information

  • Certification:CE
  • Warranty:1 year

Description

ROS1 is a receptor tyrosine kinase of insulin receptor family. Chromosomal rearrangements involving the ROS1 receptor tyrosine kinase gene occur in a subset of non–small-cell lung cancer (NSCLC). The ROS1 fusion partners include SLC34A2, CD74, SDC4, EZR etc. These fusions lead to constitutive kinase activity and activation of downstream pathways, such as JAK/STAT, PI3K/AKT, RAS/MAPK etc., leading to carcinogenesis. It has been reported that the presence of the ROS1 rearrangement is correlated with the efficacy of TKI therapy.Based on analysis of tumor messenger RNA, ROS1 gene fusions can be detected by real-time PCR method. 
 
Amoy Diagnostics has reached an agreement with OxOnc Development to use AmoyDx ROS1 Gene Fusions Detection Kit for a pivotal clinical trial of Pfizer's Xalkori (crizotinib) in Japan, Korea and China.

Intended use: 
CE marked for IVD use in Europe.
 
Technological Principles:
This kit is a nucleic acid amplifcation test for the qualitative detection of ROS1 gene fusions in NSCLC FFPE samples. The kit is based on three major processes: (1) specimen preparation to isolate total RNA from NSCLC FFPE samples; (2) reverse transcription of the target RNA to generate complementary DNA (cDNA); (3) simultaneous PCR amplification of target cDNA and detection of ROS1 gene fusions with specific primers and fluorescent probes.

Intended use: 
CE marked for IVD use in Europe.
 
Technological Principles:
This kit is a nucleic acid amplifcation test for the qualitative detection of ROS1 gene fusions in NSCLC FFPE samples. The kit is based on three major processes: (1) specimen preparation to isolate total RNA from NSCLC FFPE samples; (2) reverse transcription of the target RNA to generate complementary DNA (cDNA); (3) simultaneous PCR amplification of target cDNA and detection of ROS1 gene fusions with specific primers and fluorescent probes.




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