Amoy Diagnostics Co.,Ltd.

The AmoyDx EML4-ALK Fusion Gene Detection Kit is a sensitive and selective assay for the detection of the twenty-one most common fusion transcripts of the chimeric EML4-ALK gene.
　　
The EML4-ALK fusion oncogene represents one of the newest molecular targets in non-small-cell lung cancer (NSCLC). First described in 2007, the fusion results from a small inversion within chromosome 2p. This inversion leads to expression of a chimeric tyrosine kinase having the N-terminal half of echinoderm microtubule-associated protein-like 4 (EML4) fused to the intracellular kinase domain of anaplastic lymphoma kinase (ALK). The EML4-ALK protein possesses potent oncogenic activity both in vitro and in vivo. This activity can be blocked by small-molecule inhibitors, supporting a role for EML4-ALK as a key driver of lung tumorigenesis.
 
Intended Use: 
CE marked for IVD use in Europe and CFDA approved for clinical use in China.
 
Technological Principles: 
The EML4-ALK kit employs proprietary real-time PCR technology to detect the twenty-one most common EML4-ALK fusion transcripts. RNA that has been purified from the FFPE tissue is first reverse transcribed to cDNA with RT enzyme supplied with the kit. The EML4-ALK fusion cDNAs are then specifically amplified with cross-junction PCR primers and quantitatively detected with fluorescent probes.

Ordering Information：

AmoyDx EML4-ALK Fusion Gene Detection Kits are available in the following size, minimum order of 12 tests:
 

see the FAQs page for an explanation of "pre-loaded" and "bulk" kits.

 
Key Features and Benefits:
• Simple Procedure — only one step required for sample application, results obtained within 90 minutes.
• High sensitivity and accuracy — can detect 1% mutant DNA in a background of wild type genomic DNA.
• ADx-ARMs technology — employs a patented two-step PCR amplification procedure and novel fluorescent probe design.
• Easy Standardization — any general PCR lab can perform the test, and technicians obtain reproducible results without specialized training.
• Reliable product quality — Produced in a dedicated GMP plant, with quality management systems that have passed Chinese SFDA and international ISO13485 standards.
• Sample type: FFPE tissue; also fresh or frozen tissue.