AmoyDx® HANDLE Breast Cancer NGS Panel
NGS
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The AmoyDx® HANDLE Breast Cancer NGS Panel is a next-generation sequencing (NGS)-based assay designed for the qualitative detection of single nucleotide variants (SNVs) and insertions and deletions (InDels) in the targeted regions of five genes : AKT1, ERBB2, ESR1, PIK3CA, and PTEN. N. The assay is compatible with DNA extracted from formalin-fixed, paraffin-embedded (FFPE) breast cancer tissue samples, as well as circulating cell-free DNA (cfDNA) isolated from plasma derived from anti-coagulated peripheral whole blood samples from individuals with breast cancer.
1. Validation of the AmoyDx® HANDLE Breast Cancer NGS Panel in FFPE and Liquid Biopsy Samples
The AmoyDx® HANDLE Breast Cancer NGS Panel enables efficient testing of both plasma and FFPE samples. Its proprietary HANDLE technology supports a simple, streamlined workflow with a turnaround time of 4 working days.
Analytical validation demonstrated high accuracy, sensitivity, and precision, with consistent performance across operators and batches. The Seraseq® ESR1 reference series further confirmed analytical sensitivity and specificity.
Overall, the panel provides a rapid, sensitive, and reproducible solution for breast cancer testing across both tissue and liquid biopsy. By integrating key actionable targets in a single assay, it supports timely, evidence-based molecular findings.
White Paper
1. Validation of the AmoyDx® HANDLE Breast Cancer NGS Panel in FFPE and Liquid Biopsy Samples
The AmoyDx® HANDLE Breast Cancer NGS Panel enables efficient testing of both plasma and FFPE samples. Its proprietary HANDLE technology supports a simple, streamlined workflow with a turnaround time of 4 working days.
Analytical validation demonstrated high accuracy, sensitivity, and precision, with consistent performance across operators and batches. The Seraseq® ESR1 reference series further confirmed analytical sensitivity and specificity.
Overall, the panel provides a rapid, sensitive, and reproducible solution for breast cancer testing across both tissue and liquid biopsy. By integrating key actionable targets in a single assay, it supports timely, evidence-based molecular findings.
Mutations( Hover over each mutational type to highlight genes covered )
All
AKT1
AKT1
SNV/INDELS
ERBB2
ERBB2
SNV/INDELS
ESR1
ESR1
SNV/INDELS
PTEN
PTEN
SNV/INDELS
PIK3CA
PIK3CA
SNV/INDELS
Highly Sensitive with LOD as low as 0.2% VAF from plasma cfDNA
Fast turnaround time in 4 days
Optimized HANDLE Workflow
Cost- effective
Specifications
Sample Type
plasma cfDNA, FFPE tissue
Kit format
24 tests/kit
Sequencers
Illumina NextSeq 500, NextSeq 550, NextSeq 550Dx, Salus Pro
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