EGFR/ALK/ROS1Mutations Detection Kit
- FOB Price:Get Latest Price >
- Min.Order:1 Box(es)
- Payment Terms:T/T , Others
Amoy Diagnostics Co.,Ltd.
Amoy Diagnostics Co., Ltd. (AmoyDx) focuses on molecular diagnostics for oncology precision medicine. With completely independent intellectual property rights of ADx-ARMS and Super-ARMS technologies, AmoyDx has a market-leading portfolio of molecular diagnostic kits including but not limited to EGFR, RAS, ALK, BRAF, PIK3CA and ROS1 testing kits, which were firstly approved by CFDA and CE certified.
In European EMQN and Chinese PQCC quality control programs, AmoyDx is the NO.1 testing kit supplier for some years and always achieves the highest accuracy rate. Nowadays AmoyDx serves an extensive domestic and international oncology network reaching over 300 hospitals in China and 50 countries all over the world. Every year hundreds of thousands of cancer patients benefit from AmoyDx products.
AmoyDx is strategic diagnostics partner of AstraZeneca, Boehringer-Ingelheim, Pfizer, Merck and Illumina, providing diagnostic products and services for medicine development and clinical oncology practice. AmoyDx ROS1 kit was recently approved by Japanese authority PMDA as the sole companion diagnostic kit for Pfizer’s crizotinib, which became the 1st approved CDx kit in the world for lung cancer patients’ ROS1 testing.
Our mission is to provide customers with superior and innovative products and services to improve healthcare and patients’ lives. Our vision is to be one of the global leading and most reliable suppliers of high quality diagnostic products and services for personalized healthcare.
We endeavor to accomplish this mission and vision by:
1. Adhering to the strictest manufacturing standards to provide quality products at competitive prices.
2. Maintaining an unsurpassed level of customer service and satisfaction.
3. Pursuing scientific innovation as we provide customers with practical leading-edge technologies and value-added products.
4. Creating a world-class organization that contributes positively to the lives of our employees, our customers, the patients and the scientific community.
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.
CE marked for IVD use in Europe.
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: