Essential NGS Panel
A precise NGS panel, focus on 10 essential genes for clinical targeted therapy.

EGFR

ALK

ROS1

RET

KRAS

NRAS

PIK3CA    

BRAF

HER2

 MET

NGS
NGS Assays
2 Indications
Non-small cell lung cancer (NSCLC) | Colorectal cancer (CRC)
10 Targeted Genes
EGFR, ALK, ROS1, RET, KRAS, NRAS, PIK3CA, BRAF, HER2 and MET
5 Approved CDx biomarkers (NMPA)
EGFR 19 del, L858R | EGFR T790M | ALK Fusion | ROS1 Fusion | KRAS Mutation
2 Certificates
NMPA approved, CE-IVD marked
Features
Sample Type
- Tissue, liquid biopsy
1
- Tissue, liquid biopsy
High Ability
- Detect SNV/Indel/Fusion/CNV
2
- Detect SNV/Indel/Fusion/CNV
Limit of Detection (LoD)
- FFPE DNA: 1% MAF, cfDNA: 0.3% MAF
3
- FFPE DNA: 1% MAF, cfDNA: 0.3% MAF
High Reliability
- 100% EQA pass rate; 1000+ clinical validation.
4
- 100% EQA pass rate; 1000+ clinical validation.
Product Description

Intended Use

The AmoyDx® Essential NGS Panel (Reversible Terminator Sequencing) is a next-generation sequencing (NGS) test intended for the qualitative detection of single nucleotide variants (SNVs), insertions and deletions (Indels), gene fusions, and copy number variations (CNVs) in 10 driver genes (see Table 1) in one NGS workflow. The assay allows the detection of SNVs, Indels, fusions, and CNVs using DNA isolated from formalin-fixed paraffin-embedded (FFPE) tissue specimens, and SNVs, Indels and fusions using circulating cell-free DNA (cfDNA) isolated from plasma derived from anti-coagulated peripheral whole blood specimens.

The kit is intended to be used by trained professionals in a laboratory environment.

Principles of the Procedure

The test kit is based on dual-directional capture (ddCAP) technology which is a targeted next generation sequencing method that uses biotinylated oligonucleotide baits (probes) to hybridize to the target regions. The test kit is designed for use with fragmented gemomic DNA (gDNA) or cfDNA. During the library construction process, each individual DNA molecule is tagged with a unique molecular index (UMI) at both ends, which allows high sensitivity in variant detection by eliminating any library amplification and sequencing bias.

For FFPE tissue samples, the extracted DNA should be sheared into short fragments, using either mechanical methods (e.g. ultrasonication shearing) or enzymatic digestion, then the purified fragmented DNA can be used for downstream library preparation. For plasma samples, the extracted cfDNA can be used directly to downstream library preparation.

After quality control (QC), the qualified libraries could be sequenced on Illumina sequencing platform. The sequencing data can be analyzed by AmoyDx NGS data analysis system (ANDAS) to detect the genomic variants in the target region.

Testing Procedure
Compatible Sample Types:Tissue, liquid biopsy
Compatible NGS Instrument
Miseq
Miseq Dx
NextSeq 500
NovaSeq 6000
Other Info.

To order, please contact sales@amoydx.com.

Product Name Size (test/kit)  Storage  Cat. No.
AmoyDx® Essential NGS Panel 24T -20℃ 8.06.27401X024I

 

Publications
1. Xu, Hanyan, et al. "A comparison of EGFR mutation status in tissue and plasma cell-free DNA detected by ADx-ARMS in advanced lung adenocarcinoma patients." Translational lung cancer research 8.2 (2019): 135.
2. Wu, Wei, et al. "Comparison of the SuperARMS and ARMS for detecting EGFR mutations in liquid-based cytology specimens from NSCLC patients." Diagnostic Pathology 15.1 (2020): 1-7.

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