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The AmoyDx® Essential NGS Panel is a next-generation sequencing (NGS) based in vitro diagnostic assay intended for qualitative detection of single nucleotide variants (SNVs), insertions and deletions (InDels), gene fusions, and copy number variations (CNVs) in 10 oncogenic driver genes, using DNA isolated from formalin-fixed paraffin embedded (FFPE) tumour tissue specimens, or circulating cell free DNA (cfDNA) isolated from plasma derived from anti-coagulated peripheral whole blood specimens. The detection of CNVs is available for tissue-derived DNA only. The assay is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with non-small cell lung cancer (NSCLC) and colorectal cancer (CRC). 



 

White Paper

1. Comparative Analysis of Essential NGS Panel Data on MGI DNBSEQ-G50 and NextSeq 550

The study confirms that the AmoyDx® Essential NGS Panel performs exceptionally well on both MGI G50 and NextSeq 550 platforms. The MGI G50 demonstrated superior sequencing quality and depth while maintaining comparable accuracy, mutation frequency detection, and detection performance. These findings validate MGI G50 as a robust and reliable platform for detecting the target region of the 10 key solid tumor genes from the panel in both clinical and research applications.
 

Mutations( Hover over each mutational type to highlight genes covered )

All
CNV
FUSIONS
SNV/INDELS
EGFR

EGFR

SNV/INDELS
ALK

ALK

FUSIONS
SNV/INDELS
ROS1

ROS1

FUSIONS
SNV/INDELS
RET

RET

FUSIONS
SNV/INDELS
KRAS

KRAS

SNV/INDELS
NRAS

NRAS

SNV/INDELS
PIK3CA

PIK3CA

SNV/INDELS
BRAF

BRAF

SNV/INDELS
HER2

HER2

SNV/INDELS
MET

MET

CNV
SNV/INDELS

Fast turnaround time within 1 week

Fast turnaround time within
1 week

Automatic and secure data analysis

Automatic and secure data analysis

Target 10 driver genes for NSCLC/CRC

Target 10 driver genes for NSCLC/CRC

Detection of SNVs, InDels, fusions, CNVs

Detection of SNVs, InDels, fusions, CNVs

Specifications

Sample type
FFPE, the whole blood
Alterations detected
SNVs, Indels, Fusions, CNVs
Sequencer
IIIumina NextSeq 500, NextSeq 550, NextSeq 550Dx, MiSeq, NovaSeq 6000, Salus Pro, Saluseq Nimbo

Publications

1. Yang, James Chih-Hsin et al. Brigatinib Versus Alectinib in ALK-Positive NSCLC After Disease Progression on Crizotinib: Results of Phase 3 ALTA-3 Trial. Journal of Thoracic Oncology, Volume 18, Issue 12, 1743 - 1755.

2. Ren, W.; Zhu, Y.; Wang, Q.; Jin, H.; Guo, Y.; Lin, D. Deep Learning-Based Classification and Targeted Gene Alteration Prediction from Pleural Effusion Cell Block Whole-Slide Images. Cancers 2023, 15, 752.

3. Qiu, D., Xi, H., Wang, M. et al. The debatable role of immune checkpoint blockade therapy in lung adenocarcinoma-oriented liver metastatic malignant lesions. J Cancer Res Clin Oncol 149, 5791–5802 (2023).

4. Cai, Y., Liu, H., Chen, X., Yang, J., & Huang, B. (2023). P40 and TTF‑1 double‑expressing non‑small cell lung cancer with EML4‑ALK and PIK3CA gene mutations: A case report and review of the literature. Oncology Letters, 25, 59.

5. Takamori S, Seto T, Yamaguchi M, Kinoshita F, Fujishita T, Ito K, Toyozawa R, Shoji F and Okamoto T (2022) Case report: Success of tepotinib therapy in overcoming resistance to osimertinib in a patient with EGFR-mutant lung adenocarcinoma with a potential acquired MET exon 14 skipping mutation. Front. Oncol. 12:965741.

6. Ou, Sai-Hong Ignatius et al. Efficacy of Brigatinib in Patients With Advanced ALK-Positive NSCLC Who Progressed on Alectinib or Ceritinib: ALK in Lung Cancer Trial of brigAtinib-2 (ALTA-2). Journal of Thoracic Oncology, Volume 17, Issue 12, 1404 - 1414.

7. Ma Y, Li Q, Du Y, Chen W, Zhao G, Liu X, Li H, Liu J, Shen Z, Ma L, Zhou Y. Oncogenic Genetic Alterations in Non-Small-Cell Lung Cancer (NSCLC) in Southwestern China. Cancer Manag Res. 2020;12:10861-10874.

8. Wu, W., Huang, Y., Guo, J., Xie, X., Li, H., Cao, Z., Wei, H. and Wu, C. (2020), Detection and comparison of EGFR mutations from supernatants that contain cell-free DNA and cell pellets from FNA non–small cell lung cancer specimens. Cancer Cytopathology, 128: 545-552.

9. Wu, W., Cao, Z., Zhang, W. et al. Comparison of the SuperARMS and ARMS for detecting EGFR mutations in liquid-based cytology specimens from NSCLC patients. Diagn Pathol 15, 9 (2020).

10. Xu H, Baidoo AA, Su S, Ye J, Chen C, Xie Y, Bertolaccini L, Ismail M, Ricciuti B, Ng CS, Flores RM, Li Y; written on behalf of AME Lung Cancer Collaborative Group. A comparison of EGFR mutation status in tissue and plasma cell-free DNA detected by ADx-ARMS in advanced lung adenocarcinoma patients. Transl Lung Cancer Res 2019;8(2):135-143.

11. Xiuhuan Ji, Nanying Che, Rixu lin, Jianou Chen, Xiuling Wu. Efficient ten-gene analysis of NSCLC tissue samples by next-generation sequencing. Pathology - Research and Practice, Volume 215, Issue 5, 2019, Pages 1066-1070.

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