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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

                  Note: The listed biomarkers are key examples covered in the panel and do not represent the full list.



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
CNV
FUSIONS
HD
SNP
SNV
SNV/INDELS
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
Shelf-life
-25℃ to -15℃ for 12 months
Tests/kit
24

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