Amoy Diagnostics Co.,Ltd.

Detection of 18 EGFR mutations (exons 18-21), 5 ALK gene fusions and 9 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 18 EGFRmutations (exons 18-21), 5 ALKGene Fusions and 9 ROS1 Gene Fusions.

Intended Use: 

CE marked for IVD use in Europe.

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.

18 EGFR mutations, 5 ALK and 9 ROS1 fusions detected by the panel: