The AmoyDx ® HANDLE Insight NGS Panel is designed for the qualitative detection of single nucleotide variants (SNVs) and insertions and deletions (InDels) in the targeted regions of 10 genes (BRCA1, BRCA2, CTNNB1, EPCAM, MLH1, MSH2, MSH6, PMS2, POLE, and TP53) using DNA extracted from peripheral whole blood or formalin-fixed paraffin-embedded (FFPE) tumor tissue specimens. Additionally, the panel enables the detection of copy number variations (CNVs) in the BRCA1 and BRCA2 genes from blood-derived DNA, and the evaluation of microsatellite instability (MSI) status from FFPE tissue-derived DNA.
Compact and Cost-effective Assay for EC Molecular Classification and Hereditary Risk Assessment
Single NGS Assay for Complete EC Molecular Classification
• Enables POLE mut, MSI-H, TP53 (p53) abn, NSMP classification in one test
• Includes the emerging CTNNB1 mutation biomarker to improve risk stratification and potentially guide treatment decisions
Supports Screening for:
• Lynch Syndrome: MLH1, MSH2, MSH6, PMS2 and EPCAM
• Hereditary Breast and Ovarian Cancer Syndrome (HBOC): BRCA1 and BRCA2
Actionable Insights
• Enables MSI status evaluation, supporting immunotherapy selection in EC, CRC, etc.
• Supports treatment selection (e.g., PARP inhibitors/platinum agents for gBRCA1/2m variants)
Cost-effective Solution with Streamlined Workflow
• Proprietary HANDLE technology with one-tube workflow
• <1 hour hands-on time, <5 hours total library preparation
• Reduced sequencing cost and compatible with iSeq, MiniSeq and MiSeq
Mutations( Hover over each mutational type to highlight genes covered )
All

BRCA1
BRCA1
CNV
SNV/INDELS
BRCA2
BRCA2
CNV
SNV/INDELS
CTNNB1
CTNNB1
SNV/INDELS
EPCAM
EPCAM
SNV/INDELS
MLH1
MLH1
SNV/INDELS
MSH2
MSH2
SNV/INDELS
MSH6
MSH6
SNV/INDELS
PMS2
PMS2
SNV/INDELS
POLE
POLE
SNV/INDELS
TP53
TP53
SNV/INDELS
Specifications
Tests/kit
24
Shelf-life
-25℃ to -15℃ for 12 months
Instrument
Illumina NextSeq 500, MiSeq, MiSeqDx, MiniSeq, and iSeq 100
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