The AmoyDx ® HANDLE OncoPro NGS Panel is a qualitative next-generation sequencing (NGS) assay that provides comprehensive genomic profiling using both DNA and RNA isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens. The panel covers a total of 195 genes, enabling the detection of somatic single-nucleotide variants (SNV), insertions and deletions (InDel), gene fusions (on the RNA level), copy number amplifications (CNA), and homozygous deletions (HD). In addition, the panel also enables the evaluation of tumor microsatellite instability (MSI) status, homologous recombination deficiency (HRD) status, and the genetic polymorphisms of drug-metabolising enzymes in cancer chemotherapy
In-house Multi-biomarker Testing with Extensive Coverage of Solid Tumors

Comprehensive Tumor Profiling Made Simple
All-in-One, Pan-Tumor Solutions
• 195 pan-solid-tumor genes: all guideline-recommended and emerging biomarkers across lung, colorectal, breast, prostate, ovarian, glioma, gastric, thyroid cancers, and more.
• SNV, InDel, CNV, HD, MSI (DNA level) and Fusions, MET exon 14 skipping (RNA level)
Highlighted Advanced Biomarkers
• Homozygous Deletions (HDs): HD detection with proprietary algorithm in 26 key genes, including MTAP– a novel target for PRMT5 inhibitors.
• HRR Gene Mutations (HRRm): Covers all key HRR genes associated with FDA-approved PARPis(Olaparib, Rucaparib, Niraparib, Talazoparib).
• Microsatellite Instability (MSI) Status: Both panels provide robust MSI status assessment, offering extended insights for management strategies.
• Optional HRD Status: The AmoyDx® HANDLE OncoPro NGS Panel adds integrated Homologous Recombination Deficiency (HRD) status assessment for deeper insights into genomic instability.
Comprehensive Tumor Profiling Powered by HANDLE
• Decentralized and cost-effective solution, making in-house tumor profiling accessible
• Streamlined workflow with one-tube operations
• < 1 hour hands-on time, < 6 hours total library preparation with 3-day turnaround time
Mutations( Hover over each mutational type to highlight genes covered )
All

ABRAXAS1
ABRAXAS1
SNV/INDELS
ABTB2
ABTB2
SNP
AKT1
AKT1
SNV/INDELS
AKT2
AKT2
CNV
SNV/INDELS
AKT3
AKT3
SNV/INDELS
ALK
ALK
FUSIONS
SNV/INDELS
APC
APC
SNV/INDELS
AR
AR
FUSIONS
SNV/INDELS
ARAF
ARAF
SNV/INDELS
ARID1A
ARID1A
SNV/INDELS
ARID1B
ARID1B
SNV/INDELS
ARID2
ARID2
SNV/INDELS
ATM
ATM
HD
SNV/INDELS
ATR
ATR
SNV/INDELS
ATRX
ATRX
SNV/INDELS
AURKA
AURKA
SNV/INDELS
AXIN1
AXIN1
SNV/INDELS
B2M
B2M
SNV/INDELS
BAP1
BAP1
SNV/INDELS
BARD1
BARD1
HD
SNV/INDELS
BMPR1A
BMPR1A
SNV/INDELS
BRAF
BRAF
FUSIONS
SNV/INDELS
BRCA1
BRCA1
HD
SNV/INDELS
BRCA2
BRCA2
HD
SNV/INDELS
BRD3
BRD3
FUSIONS
BRD4
BRD4
FUSIONS
BRIP1
BRIP1
HD
SNV/INDELS
CCND1
CCND1
SNV/INDELS
CCNE1
CCNE1
CNV
SNV/INDELS
CD274
CD274
CNV
CDH1
CDH1
CNV
SNV/INDELS
CDK12
CDK12
HD
SNV/INDELS
CDK4
CDK4
CNV
SNV/INDELS
CDK6
CDK6
CNV
SNV/INDELS
CDKN1B
CDKN1B
SNV/INDELS
CDKN2A
CDKN2A
HD
SNV/INDELS
CDKN2B
CDKN2B
HD
SNV/INDELS
CHD1
CHD1
SNV/INDELS
CHEK1
CHEK1
HD
SNV/INDELS
CHEK2
CHEK2
HD
SNV/INDELS
CLDN18
CLDN18
FUSIONS
CTNNB1
CTNNB1
SNV/INDELS
CYP17A1
CYP17A1
SNV/INDELS
CYP2D6
CYP2D6
SNP
DDR2
DDR2
SNV/INDELS
DICER1
DICER1
SNV/INDELS
DNAJB1
DNAJB1
FUSIONS
DNMT3A
DNMT3A
SNV/INDELS
DPYD
DPYD
SNP
EGFR
EGFR
CNV
FUSIONS
SNV/INDELS
EIF1AX
EIF1AX
SNV/INDELS
ELK4
ELK4
FUSIONS
EPCAM
EPCAM
SNV/INDELS
ERBB2
ERBB2
CNV
SNV/INDELS
ERBB3
ERBB3
SNV/INDELS
ERCC1
ERCC1
SNP
ERCC2
ERCC2
SNV/INDELS
ERG
ERG
FUSIONS
ESR1
ESR1
CNV
SNV/INDELS
ETV1
ETV1
FUSIONS
ETV4
ETV4
FUSIONS
ETV5
ETV5
FUSIONS
EZH2
EZH2
SNV/INDELS
FANCA
FANCA
HD
SNV/INDELS
FANCC
FANCC
SNV/INDELS
FANCD2
FANCD2
SNV/INDELS
FANCL
FANCL
HD
SNV/INDELS
FAT1
FAT1
SNV/INDELS
FBXW7
FBXW7
SNV/INDELS
FGF19
FGF19
CNV
FGFR1
FGFR1
CNV
FUSIONS
SNV/INDELS
FGFR2
FGFR2
CNV
FUSIONS
SNV/INDELS
FGFR3
FGFR3
CNV
FUSIONS
SNV/INDELS
FGFR4
FGFR4
SNV/INDELS
FH
FH
SNV/INDELS
FLT3
FLT3
CNV
SNV/INDELS
FOXA1
FOXA1
SNV/INDELS
GATA3
GATA3
SNV/INDELS
GATA6
GATA6
CNV
GEN1
GEN1
SNV/INDELS
GLI1
GLI1
CNV
GLI2
GLI2
CNV
SNV/INDELS
GNA11
GNA11
SNV/INDELS
GNA14
GNA14
SNV/INDELS
GNAQ
GNAQ
SNV/INDELS
GNAS
GNAS
SNV/INDELS
GSTP1
GSTP1
SNP
GTF2I
GTF2I
SNV/INDELS
H3-3A
H3-3A
SNV/INDELS
H3C2
H3C2
SNV/INDELS
H3C3
H3C3
SNV/INDELS
HDAC2
HDAC2
HD
SNV/INDELS
HOXB13
HOXB13
HD
SNV/INDELS
HRAS
HRAS
SNV/INDELS
HSD3B1
HSD3B1
SNV/INDELS
IDH1
IDH1
SNV/INDELS
IDH2
IDH2
SNV/INDELS
IFNGR1
IFNGR1
SNV/INDELS
IFNGR2
IFNGR2
SNV/INDELS
JAK1
JAK1
SNV/INDELS
JAK2
JAK2
SNV/INDELS
KDM5C
KDM5C
SNV/INDELS
KDM6A
KDM6A
SNV/INDELS
KEAP1
KEAP1
SNV/INDELS
KIT
KIT
SNV/INDELS
KMT2B
KMT2B
SNV/INDELS
KMT2C
KMT2C
SNV/INDELS
KMT2D
KMT2D
SNV/INDELS
KRAS
KRAS
SNV/INDELS
LTK
LTK
FUSIONS
MAP2K1
MAP2K1
SNV/INDELS
MAP2K4
MAP2K4
SNV/INDELS
MDM2
MDM2
CNV
SNV/INDELS
MDM4
MDM4
CNV
MET
MET
CNV
FUSIONS
SNV/INDELS
MLH1
MLH1
SNV/INDELS
MLH3
MLH3
SNV/INDELS
MMS22L
MMS22L
HD
SNV/INDELS
MRE11
MRE11
SNV/INDELS
MSH2
MSH2
SNV/INDELS
MSH3
MSH3
SNV/INDELS
MSH6
MSH6
SNV/INDELS
MTAP
MTAP
HD
SNV/INDELS
MTOR
MTOR
SNV/INDELS
MUTYH
MUTYH
SNV/INDELS
MYB
MYB
FUSIONS
MYC
MYC
CNV
MYCN
MYCN
SNV/INDELS
NBN
NBN
SNV/INDELS
NF1
NF1
HD
SNV/INDELS
NF2
NF2
SNV/INDELS
NFE2L2
NFE2L2
SNV/INDELS
NKX2-1
NKX2-1
CNV
NRAS
NRAS
SNV/INDELS
NRG1
NRG1
FUSIONS
NSD3
NSD3
FUSIONS
NTRK1
NTRK1
FUSIONS
SNV/INDELS
NTRK2
NTRK2
FUSIONS
SNV/INDELS
NTRK3
NTRK3
FUSIONS
SNV/INDELS
NUTM1
NUTM1
FUSIONS
PALB2
PALB2
HD
SNV/INDELS
PAX8
PAX8
FUSIONS
PBRM1
PBRM1
SNV/INDELS
PDCD1LG2
PDCD1LG2
CNV
PDGFRA
PDGFRA
SNV/INDELS
PIK3CA
PIK3CA
SNV/INDELS
PIK3R1
PIK3R1
SNV/INDELS
PMS2
PMS2
SNV/INDELS
POLD1
POLD1
SNV/INDELS
POLE
POLE
SNV/INDELS
PPP2R1A
PPP2R1A
SNV/INDELS
PRKACA
PRKACA
SNV/INDELS
PTCH1
PTCH1
SNV/INDELS
PTCH2
PTCH2
SNV/INDELS
PTEN
PTEN
HD
SNV/INDELS
QKI
QKI
FUSIONS
RAD50
RAD50
SNV/INDELS
RAD51B
RAD51B
HD
SNV/INDELS
RAD51C
RAD51C
HD
SNV/INDELS
RAD51D
RAD51D
HD
SNV/INDELS
RAD54L
RAD54L
HD
SNV/INDELS
RAF1
RAF1
CNV
SNV/INDELS
RASA1
RASA1
HD
SNV/INDELS
RASGRF1
RASGRF1
FUSIONS
RB1
RB1
SNV/INDELS
RBM10
RBM10
SNV/INDELS
RET
RET
FUSIONS
SNV/INDELS
RICTOR
RICTOR
CNV
RIT1
RIT1
SNV/INDELS
RNF43
RNF43
SNV/INDELS
ROS1
ROS1
FUSIONS
SNV/INDELS
SETD2
SETD2
HD
SNV/INDELS
SF3B1
SF3B1
SNV/INDELS
SMAD4
SMAD4
SNV/INDELS
SMARCA2
SMARCA2
SNV/INDELS
SMARCA4
SMARCA4
SNV/INDELS
SMARCB1
SMARCB1
SNV/INDELS
SMO
SMO
SNV/INDELS
SPOP
SPOP
SNV/INDELS
STAT3
STAT3
SNV/INDELS
STK11
STK11
SNV/INDELS
SUFU
SUFU
SNV/INDELS
TERT
TERT
SNV
TET2
TET2
SNV/INDELS
TGFBR2
TGFBR2
SNV/INDELS
TP53
TP53
HD
SNV/INDELS
TSC1
TSC1
SNV/INDELS
TSC2
TSC2
SNV/INDELS
UGT1A1
UGT1A1
SNP
VEGFA
VEGFA
CNV
SNV/INDELS
VHL
VHL
SNV/INDELS
YAP1
YAP1
FUSIONS
ZFTA
ZFTA
FUSIONS
ZNF532
ZNF532
FUSIONS
ZNF592
ZNF592
FUSIONS
Specifications
Instrument
24 tests/kit
Illumina NextSeq 500, NextSeq 550, NextSeq 550Dx
Illumina NextSeq 500, NextSeq 550, NextSeq 550Dx
Shelf-life
-25℃ to -15℃ for 12 months
Tests/kit
24
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