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COMING SOON!
A visionary diagnostic company dedicated to transforming the landscape of cancer care. 'Breaking Barriers to Precision Oncology' reflects our commitment to revolutionizing cancer diagnosis and treatment.

We are driven by four fundamental values: Innovation in Care, Accessibility and Equity, Collaboration and Partnership, and Integrity and Trust.
These values guide our pursuit of developing groundbreaking diagnostic tools and fostering a more equitable, collaborative, and trustworthy approach to oncology.

Join us as we pave the way to a future where precision cancer care is a reality for every patient, everywhere.

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Breaking Barriers To Precision Oncology

Products by Technology

NGS
PCR
IHC
Extraction Kits
All Products

Core Technologies

NGS

NGS Products

AmoyDx HANDLE®

AmoyDx HANDLE®

Making Complex NGS Testing “Easy to Handle”

The AmoyDx HANDLE® technology is a proprietary amplicon-based method for NGS library preparation.
It offers a time-saving and cost-effective protocol that can be completed within 5 hours, requiring just about 1 hour of hands-on time.

During the library construction process, each individual DNA molecule is tagged with a unique molecular index (UMI) at both ends. This feature enables high sensitivity in variant detection by eliminating any library amplification and sequencing bias.

The probe consists of an extension arm and a ligation arm, both complementary to the target gene region.
Target-specific probes simultaneously hybridize to the DNA/cDNA fragment, forming a circular structure with the intended target captured between the probes. Subsequently, remaining linear probes, single-strand, and double-strand DNA are digested, leaving only the target circular DNA for PCR amplification to form the final library.

AmoyDx ddCapture®

AmoyDx ddCapture®

Every Strand Matters

  • AmoyDx dual-directional capture (ddCapture) technology is a proprietary capture-based approach that utilizes biotinylated oligonucleotide baits (probes) to hybridize to regions of interest, offering an efficient NGS protocol suitable for both FFPE tissue and liquid biopsy testing.

  • During the library construction process, each individual DNA molecule is tagged with a unique molecular index (UMI) at both ends, ensuring high sensitivity in variant detection by eliminating library amplification and sequencing bias.

  • The fragmented DNA/cDNA (or cfDNA) undergoes incubation with end repair and A-tailing enzymes/reagents to generate blunt-ended fragments with dA-tails. These fragments are then ligated to adapters with complementary dT-overhangs. These adapters contain sequences that facilitate binding of the DNA fragments to the flow cell. Subsequently, PCR amplification enriches the libraries and labels each library with unique dual indexes.

  • Target enrichment of the libraries follows, involving denaturation of double-stranded libraries, hybridization of biotinylated probes to targeted regions, and enrichment using streptavidin beads. Finally, an additional PCR amplification with universal primers amplifies the enriched libraries.

ANDAS

  • Sequencing data generated with AmoyDx NGS products can be conveniently and securely analyzed using the AmoyDx NGS Data Analysis System (ANDAS). The ANDAS Data Analyzer consists of a local server and preinstalled ANDAS software equipped with specific analysis modules tailored for analyzing data from various AmoyDx NGS products.

  • The ANDAS server is installed within the same local network as the sequencer, providing the laboratory with complete control over data and security. This ensures the protection of valuable sequencing data and downstream analysis results, including sensitive patient information. Accessible via a computer within the network, the ANDAS server and its preinstalled software offer an intuitive user interface for swift and straightforward analysis generation.

PCR

PCR Products

AmoyDx ADx-ARMS®

ADx-ARMS®

Amplifed Refractory Mutation System) Technology

ADx-ARMS® technology enables the detection of gene mutations by designing a specific primer at the mutation site. This technology leverages the capability of DNA polymerase to differentiate between a matched and a mismatched base at the 3’ end of a PCR primer.

In cases where the 3’ base of the primer perfectly matches the mutant template, amplification proceeds efficiently. Conversely, when the 3’ base mismatches with the wild-type template, amplification efficiency is significantly reduced.
This selective amplification allows for the detection of specific mutated sequences even in samples where the majority of DNA lacks the mutation.

AmoyDx Super-ARMS®

SUPER-ARMS

Sensitivity Increased to 0.2%.

Super-ARMS® represents an advancement over traditional ARMS technology achieved through enhanced primer and probe design.
With Super-ARMS, efficient amplification occurs when the 3’ base of the primer perfectly matches the mutant template. Conversely, if the 3’ base mismatches with the wild-type template, amplification efficiency is significantly reduced.

The refined primer design significantly enhances both specificity and sensitivity, offering improved performance in mutation detection.

ARAS

Automated Result Analysis System

AmoyDx® Automated Result Analysis System (ARAS), an advanced software designed to automate the interpretation of AmoyDx PCR data, elevating your laboratory workflow to new heights. ARAS is crafted to streamline PCR data analysis, delivering timely and comprehensive results with a focus on precision and efficiency.

Explore our online educational web-based ARAS software at http://support.amoydx.com/, designed for training, evaluation, and troubleshooting.

Easy to use

Fast

Secure

Compatibility

Products by Technology

PCR

Oroduct Name CatalogNo.
AmoyDx® EGFR 29 Mutations Detection Kit – CE-IVDD 8.01.0004
AmoyDx® EGFR 29 Mutations Detection Kit – CE-IVDD 8.01.0005
AmoyDx® EGFR 29 Mutations Detection Kit – CE-IVDD 8.01.0006
AmoyDx® EGFR 29 Mutations Detection Kit – CE-IVDD 8.01.0134
AmoyDx® EGFR 29 Mutations Detection Kit – RUO 8.01.0049
AmoyDx® EGFR 29 Mutations Detection Kit – RUO 8.01.0050
AmoyDx® EGFR 29 Mutations Detection Kit – RUO 8.01.0051
AmoyDx® EGFR 29 Mutations Detection Kit – RUO 8.01.0052
AmoyDx® EGFR 29 Mutations Detection Kit – RUO 8.01.0053
Super-ARMS® EGFR Mutation Detection Kit – CE-IVDD 8.01.0148
Super-ARMS® EGFR Mutation Detection Kit – RUO (31 mutations) 8.01.0056
Super-ARMS® EGFR Mutation Detection Kit – RUO (31 mutations) 8.01.0107
AmoyDx® ROS1 Gene Fusions Detection Kit – CE-IVDD 8.01.0165
AmoyDx® ROS1 Gene Fusions Detection Kit – RUO 8.01.0062
AmoyDx® ALK Gene Fusions and ROS1 Gene Fusions Detection Kit – CE-IVDD 8.01.0024
AmoyDx® ALK Gene Fusions and ROS1 Gene Fusions Detection Kit – CE-IVDD 8.01.0026
AmoyDx® ALK Gene Fusions and ROS1 Gene Fusions Detection Kit – RUO 8.01.0064
AmoyDx® ALK Gene Fusions and ROS1 Gene Fusions Detection Kit – RUO 8.01.0066
AmoyDx® Pan Lung Cancer PCR Panel – CE-IVDD 8.01.0246
AmoyDx® Pan Lung Cancer PCR Panel – CE-IVDD 8.01.0247
AmoyDx® Pan Lung Cancer PCR Panel – RUO 8.01.0211
AmoyDx® Pan Lung Cancer PCR Panel – RUO 8.01.0234
AmoyDx® Pan Lung Cancer PCR Panel – RUO 8.01.0279
AmoyDx® KRAS Mutation Detection Kit – CE-IVDD 8.01.0001
AmoyDx® KRAS Mutation Detection Kit – CE-IVDD 8.01.0002
AmoyDx® KRAS Mutation Detection Kit – CE-IVDD 8.01.0128
AmoyDx® KRAS Mutation Detection Kit – RUO 8.01.0045
AmoyDx® KRAS Mutation Detection Kit – RUO 8.01.0046
AmoyDx® KRAS Mutation Detection Kit – RUO 8.01.0048
AmoyDx® NRAS Mutation Detection Kit – CE-IVDD 8.01.0172
AmoyDx® NRAS Mutation Detection Kit – CE-IVDD 8.01.0027
AmoyDx® NRAS Mutation Detection Kit – RUO 8.01.0070
AmoyDx® NRAS Mutation Detection Kit – RUO 8.01.0067
AmoyDx® BRAF V600 Mutations Detection Kit – CE-IVDD 8.01.0153
AmoyDx® BRAF V600 Mutations Detection Kit – RUO 8.01.0054
AmoyDx® KRAS/NRAS Mutations Detection Kit – CE-IVDD 8.01.0030
AmoyDx® KRAS/NRAS Mutations Detection Kit – CE-IVDD 8.01.0032
AmoyDx® KRAS/NRAS Mutations Detection Kit – CE-IVDD 8.01.0179
AmoyDx® KRAS/NRAS Mutations Detection Kit – RUO 8.01.0071
AmoyDx® KRAS/NRAS Mutations Detection Kit – RUO 8.01.0073
AmoyDx® KRAS/NRAS Mutations Detection Kit – RUO 8.01.0074
AmoyDx® KRAS/NRAS/BRAF Mutations Detection Kit – CE-IVDD 8.01.0033
AmoyDx® KRAS/NRAS/BRAF Mutations Detection Kit – CE-IVDD 8.01.0034
AmoyDx® KRAS/NRAS/BRAF Mutations Detection Kit – CE-IVDD 8.01.0035
AmoyDx® KRAS/NRAS/BRAF Mutations Detection Kit – RUO 8.01.0075
AmoyDx® KRAS/NRAS/BRAF Mutations Detection Kit – RUO 8.01.0075
AmoyDx® KRAS/NRAS/BRAF Mutations Detection Kit – RUO 8.01.0077
AmoyDx® EML4-ALK Fusion Gene Detection Kit – CE-IVDD 8.01.22001X024H
AmoyDx® EML4-ALK Fusion Gene Detection Kit – RUO 8.01.0090
AmoyDx® EGFR/ALK/ROS1 Mutations Detection Kit – RUO 8.01.0079
AmoyDx® EGFR/ALK/ROS1 Mutations Detection Kit – RUO 8.01.0081
AmoyDx® EGFR/ALK/ROS1 Mutations Detection Kit – RUO 8.01.0082
AmoyDx® Multi-Gene Mutations Detection Kit – CE-IVDD 8.01.26301W006A
AmoyDx® Multi-Gene Mutations Detection Kit – CE-IVDD 8.01.26301W006B
AmoyDx® Multi-Gene Mutations Detection Kit – CE-IVDD 8.01.26301W006D
AmoyDx® Multi-Gene Mutations Detection Kit – CE-IVDD 8.01.26301W006J
AmoyDx® Multi-Gene Mutations Detection Kit – RUO 8.01.0083
AmoyDx® Multi-Gene Mutations Detection Kit – RUO 8.01.0084
AmoyDx® Multi-Gene Mutations Detection Kit – RUO 8.01.0085
AmoyDx® Multi-Gene Mutations Detection Kit – RUO 8.01.0086
AmoyDx® MET Mutation Detection Kit – RUO 8.01.0123
AmoyDx® HER2 Mutation Detection Kit – RUO 8.01.0232
AmoyDx® NTRK Gene Fusions Detection Kit – CE-IVDD 8.0126001X024E
AmoyDx® NTRK Gene Fusions Detection Kit – RUO 8.01.0212
AmoyDx® BRAF Mutation Detection Kit (V2) – RUO 8.01.0155
AmoyDx® BRAF Mutation Detection Kit (V2) – RUO 8.01.0104
AmoyDx® BRAF Mutation Detection Kit (V2) – RUO 8.01.0105
AmoyDx® PIK3CA Five Mutations Detection Kit – RUO 8.01.0057
AmoyDx® PIK3CA Five Mutations Detection Kit – RUO 8.01.0058
AmoyDx® PIK3CA Mutation Detection Kit – CE-IVDD 8.0121602X024E
AmoyDx® PIK3CA Mutation Detection Kit – RUO 8.01.0227
AmoyDx® RET Gene Fusions Detection Kit – RUO 8.01.0063
AmoyDx® JAK2 Mutation Detection Kit – RUO 8.01.0089
AmoyDx® JAK2 Mutation Detection Kit – RUO 8.01.0267
AmoyDx® TERT/HRAS Mutations Detection Kit – RUO 8.01.0087
AmoyDx® TERT/HRAS Mutations Detection Kit – RUO 8.01.0088
AmoyDx® Human Papillomavirus (HPV) Genotyping Detection Kit – CE-IVDD 8.01.25803X048E
AmoyDx® Human Papillomavirus (HPV) Genotyping Detection Kit – RUO 8.01.0093
Super-ARMS® EGFR Mutation Detection Reagent (V2) (for color compensation) – RUO 8.01.0249
AmoyDx® Pan Lung Cancer Detection Reagent (V2) (for color compensation) – RUO 8.01.0250
SLAN-96S Real-time PCR instrument – RUO 8.01.0158
SLAN-96S Real-time PCR instrument – RUO 8.01.0124
AmoyDx® Microsatellite Instability (MSI) Detection Kit – RUO 8.01.0158
AmoyDx® Microsatellite Instability (MSI) Detection Kit – RUO 8.01.0124
AmoyDx® Microsatellite Instability (MSI) Detection Kit – RUO 8.01.0263
AmoyDx® Microsatellite Instability (MSI) Detection Kit – RUO 8.01.0255

Extraction Kits

Oroduct Name CatalogNo.
Extraction kit AmoyDx® FFPE DNA Kit – CE-IVDR 8.02.0001
Extraction kit AmoyDx® FFPE DNA Kit – RUO 8.02.0005
Extraction kit AmoyDx® FFPE RNA Kit – CE-IVDR 8.02.0003
Extraction kit AmoyDx® FFPE RNA Kit – RUO 8.02.0007
Extraction kit AmoyDx® FFPE DNA/RNA Kit – CE-IVDR 8.02.0002
Extraction kit AmoyDx® FFPE DNA/RNA Kit – RUO 8.02.0006
Extraction kit AmoyDx® Magnetic FFPE DNA Extraction Kit – CE-IVDR 8.02.0098
Extraction kit AmoyDx® Magnetic FFPE DNA Extraction Kit – RUO 8.02.0097
Extraction kit AmoyDx® Blood/Bone Marrow DNA Kit – CE-IVDR 8.02.0077
Extraction kit AmoyDx® Blood/Bone Marrow DNA Kit – RUO 8.02.0008
Extraction kit AmoyDx® Circulating DNA Kit – CE-IVDR 8.02.0004
Extraction kit AmoyDx® Circulating DNA Kit – RUO 8.02.0012
Extraction kit AmoyDx® Tissue DNA Kit – CE-IVDR 8.02.0078
Extraction kit AmoyDx® Tissue DNA Kit – RUO 8.02.0009
Extraction kit AmoyDx® Tissue RNA Kit – CE-IVDR 8.02.0079
Extraction kit AmoyDx® Tissue RNA Kit – RUO 8.02.0010
Collection Tube AmoyDx® Cell-free DNA Protection Vacuum Tube – RUO 8.02.0033

All Products

AmoyDx® HRD Focus Panel

Technology
NGS

Tumor
Ovarian cancer

Certificate

 

AmoyDx® HRD Focus Panel

How to determine HRD status?

When the homologous recombination (HR) pathway is disrupted
by gene mutations, promoter methylation, or undetermined causes, the HR pathway stops working, leading to Homologous Recombination Deficiency (HRD).

Tumors with HRD cannot repair themselves effectively after sustaining damage, contributing to genomic instability. There are limitations to determining HRD status when evaluating each ’cause’/ cause individually. Evaluating genomic instability allows
for the assessment of HRD regardless of the specific cause.

HRD status can be measured by “cause” through mutations in the HRR pathway (e.g., BRCA1 and BRCA2) and by the “effect” of the presence of genomic scars at a given threshold or functional assay. HRD testing can identify 30% more PARPi-effective population than BRCA testing. (BRCA~20% vs. HRD~50%).

The AmoyDx® HRD Focus Panel offers dependable and cost-effective solutions for evaluating PARP inhibitor (PARPi)-related biomarkers and advancing targeted treatment research in ovarian cancer. Leveraging proprietary HANDLE technology, the Genomic Scar Score (GSS) algorithm, and the AmoyDx NGS Data Analysis System (ANDAS), the HRD Focus assay can be seamlessly integrated into your laboratory workflow. Our methodologies enable streamlined end-to-end solutions, requiring less than 1 hour of hands-on operation, delivering high-performance assessment of genomic instability, and providing automated and secure data analysis.

Comprehensively Designed GSS Algorithm

The AmoyDx proprietary GSS algorithm is a machine learning-based model which assesses genomic instability by analyzing different types of copy number events across the genome.1

Longer PFS with PARPi Treatment for GSS-positive Group

The study highlights the promising value of GSS in identifying patients
who may respond favorably to PARPi treatment.

1. Yuan W, Ni J, Wen H, et al. Genomic Scar Score: A robust model predicting homologous recombination deficiency based on genomic instability. BJOG. 2022;129 Suppl 2:14-22. doi:10.1111/1471-0528.17324.

Mutations

SNV/INDELS

  • BRCA1
  • BRCA2

Cost-effective

Decentralized assay solution with ease of use

Fast turnaround time within 3 days

Detection of BRCA1/2 genes (SNVs/InDels) and Genomic Scar Score (GSS)

Specifications

Target regions whole coding regions and intron/exon boundaries of BRCA1 and BRCA2 genes, and ~24,000 genome-wide SNPs
Alterations detected BRCA1/2 genes (SNVs/InDels) and Genomic Scar Score (GSS)
Sample type FFPE tissue
DNA input Optimal 100ng (minimum 50ng)
Data output per sample 4 Gb
Sequencing type PE150
Sequencer Illumina NextSeq 550Dx
TAT for library prep 5 hours (hands-on time <1 hour )
TAT from sample to report 3 days

Technology

The AmoyDx HANDLE® technology is a proprietary amplicon-based method for NGS library preparation.
It offers a time-saving and cost-effective protocol that can be completed within 5 hours, requiring just about 1 hour of hands-on time.

During the library construction process, each individual DNA molecule is tagged with a unique molecular index (UMI) at both ends. This feature enables high sensitivity in variant detection by eliminating any library amplification and sequencing bias.

The probe consists of an extension arm and a ligation arm, both complementary to the target gene region.
Target-specific probes simultaneously hybridize to the DNA/cDNA fragment, forming a circular structure with the intended target captured between the probes. Subsequently, remaining linear probes, single-strand, and double-strand DNA are digested, leaving only the target circular DNA for PCR amplification to form the final library.

AmoyDx® HRD Complete Panel

Technology
NGS

Tumor
Breast cancer/ Ovarian cancer/ Prostate cancer

Certificate

AmoyDx® HRD Complete Panel

How to determine HRD status?

When the homologous recombination (HR) pathway is disrupted by gene mutations, promoter methylation, or undetermined causes, the HR pathway stops working, leading to Homologous Recombination Deficiency (HRD).

Tumors with HRD cannot repair themselves effectively after sustaining damage, contributing to genomic instability. There are limitations to determining HRD status when evaluating each ’cause’/ cause individually. Evaluating genomic instability allows for the assessment of HRD regardless of the specific cause.

HRD status can be measured by “cause” through mutations in the HRR pathway (e.g., BRCA1 and BRCA2) and by the “effect” of the presence of genomic scars at a given threshold or functional assay. HRD testing can identify 30% more PARPi-effective population than BRCA testing. (BRCA~20% vs. HRD~50%)

AmoyDx® HRD Complete Panel​ offers a comprehensive homologous recombination deficiency (HRD) test designed to simultaneously detect genetic abberations across 20 HRR genes and HRD status.

Comprehensively Designed GSS Algorithm

The AmoyDx proprietary GSS algorithm is a machine learning-based model which assesses genomic instability by analyzing different types of copy number events across the genome.

Longer PFS with PARPi Treatment for GSS-positive Group

The study highlights the promising value of GSS in identifying patients
who may respond favorably to PARPi treatment.

Mutations

SNV/INDELS

  • ATM
  • BARD1
  • BRCA1
  • BRCA2
  • BRIP1
  • CDH1
  • CDK12
  • CHEK1
  • CHEK2
  • FANCA
  • FANCL
  • HDAC2
  • PALB2
  • PPP2R2A
  • PTEN
  • RAD51B
  • RAD51C
  • RAD51D
  • RAD54L
  • TP53

HD

  • ATM
  • BARD1
  • BRCA1
  • BRCA2
  • BRIP1
  • CDH1
  • CDK12
  • CHEK1
  • CHEK2
  • FANCA
  • FANCL
  • HDAC2
  • PALB2
  • PPP2R2A
  • PTEN
  • RAD51B
  • RAD51C
  • RAD51D
  • RAD54L
  • TP53

Fast turnaround time within 3 days

Cost-effective

Streamlined one-tube workflow

Secure data analysis and interpretation

Specifications

Alterations detected 20 HRR genes (SNV/InDel/HD) and Genomic Scar Score (GSS)
Sample type FFPE tissue
DNA input Optimal 100ng (minimum 50ng)
Data output per sample 4 Gb
Sequencing type PE150
Sequencer Illumina NextSeq 500/550, NovaSeq 6000
TAT for library prep 5 hours (hands-on time <1 hour )
TAT from sample to report 3 days

AmoyDx® Master Panel

Technology
NGS

Tumor
Pan-tumor/ Non-small cell lung cancer/ Colorectal cancer/ Breast cancer/ Thyroid cancer/ Ovarian cancer/ Prostate cancer/ Pancreatic cancer/ Gastric(Stomach) cancer

Certificate

Comprehensive Genomic Profiling (CGP) assays are increasingly utilized in clinical practices, offering an efficient means of maximizing the utility of limited tissue biopsies by assessing multiple cancer-relevant biomarkers simultaneously. By covering actionable and emerging biomarkers, CGP assays hold promise in identifying diverse therapeutic pathways and innovative clinical trial options for cancer patients.

The “Most Comprehensive”
Genomic Profiling Assay
Gain actionable molecular insights
on 48 cancer types

The AmoyDx Master Panel facilitates the concurrent detection of both DNA and RNA biomarkers. On the DNA level, it encompasses 571 genes, encompassing biomarkers associated with approved targeted therapies, as well as those recommended by guidelines/consensus or under investigation in clinical trials. In addition to SNV/indel, fusion, and CNV analysis, the Master Panel also evaluates complex signatures such as HRD, MSI, and TMB. On the RNA level, it surveys over 2000 genes, detecting fusions and alternative splicing while analyzing levels of genes implicated in cancer pathways. Furthermore, it enables the assessment of select immunotherapy biomarkers like GEP and TME.

Mutations

SNV/INDELS

  • ABL1
  • ALK
  • AP3B1
  • AR
  • BCL2L11
  • BCR
  • BRAF
  • CD74
  • CDK12
  • EGFR
  • EIF4A2
  • ERBB2
  • ERBB4
  • ERG
  • ESR1
  • ETV1
  • ETV4
  • ETV5
  • ETV6
  • EWSR1
  • FGFR1
  • FGFR2
  • FGFR3
  • FGFR4
  • FLT3
  • FOXO1
  • HEY1
  • HLA-A
  • JAK2
  • KIT
  • MET
  • MYB
  • NAB2
  • NCOA2
  • NOTCH2
  • NPM1
  • NR4A3
  • NSD1
  • NTRK1
  • NTRK2
  • NTRK3
  • PAX8
  • PDGFB
  • PDGFRA
  • PDGFRB
  • PPARG
  • PRKAR1A
  • QKI
  • RAF1
  • RANBP2
  • RARA
  • RET
  • ROS1
  • SS18
  • STAT3
  • STAT6
  • TFE3
  • TMPRSS2
  • TP53
  • YWHAE
  • ZNF703
  • ABCB1
  • ABL2
  • ABRAXAS1
  • ACVR1B
  • AGO1
  • AKT1
  • AKT2
  • AKT3
  • ALOX12B
  • AMER1
  • APC
  • APC2
  • ARAF
  • ARFRP1
  • ARID1A
  • ARID1B
  • ARID2
  • ARID5B
  • ASXL1
  • ATM
  • ATR
  • ATRX
  • AURKA
  • AURKB
  • AXIN1
  • AXIN2
  • AXL
  • B2M
  • BAP1
  • BARD1
  • BCL2
  • BCL2L1
  • BCL2L2
  • BCL6
  • BCOR
  • BCORL1
  • BIRC3
  • BLK
  • BLM
  • BMPR1A
  • BRCA1
  • BRCA2
  • BRD3
  • BRD4
  • BRIP1
  • BTG1
  • BTK
  • CALR
  • CARD11
  • CASP8
  • CBFB
  • CBL
  • CCN6
  • CCND1
  • CCND2
  • CCND3
  • CCNE1
  • CD274
  • CD34
  • CD79A
  • CD79B
  • CD80
  • CD86
  • CDC73
  • CDH1
  • CDK4
  • CDK6
  • CDK8
  • CDKN1A
  • CDKN1B
  • CDKN2A
  • CDKN2B
  • CDKN2C
  • CEBPA
  • CHD2
  • CHD4
  • CHEK1
  • CHEK2
  • CIC
  • CREBBP
  • CRKL
  • CRLF2
  • CSF1
  • CSF1R
  • CSF3R
  • CTCF
  • CTLA4
  • CTNNA1
  • CTNNB1
  • CUL3
  • CYLD
  • CYP2D6
  • DAXX
  • DCUN1D1
  • DDR1
  • DDR2
  • DICER1
  • DIS3
  • DKK3
  • DNMT1
  • DNMT3A
  • DOT1L
  • DPYD
  • EED
  • EIF1AX
  • EMSY
  • EP300
  • EPAS1
  • EPCAM
  • EPHA3
  • EPHA5
  • EPHA6
  • EPHA7
  • EPHB1
  • ERBB3
  • ERCC1
  • ERCC2
  • ERCC3
  • ERRFI1
  • ETS2
  • EZH2
  • FANCA
  • FANCC
  • FANCD2
  • FANCE
  • FANCF
  • FANCG
  • FANCI
  • FANCL
  • FANCM
  • FAS
  • FAT1
  • FBXW7
  • FCGR2B
  • FGF10
  • FGF14
  • FGF19
  • FGF23
  • FGF3
  • FGF4
  • FGF6
  • FGF7
  • FGR
  • FH
  • FLCN
  • FLT1
  • FLT4
  • FOXA1
  • FOXL2
  • FOXP1
  • FRS2
  • FUBP1
  • FUS
  • FYN
  • GABRA6
  • GATA1
  • GATA2
  • GATA3
  • GATA4
  • GATA6
  • GEN1
  • GLI1
  • GNA11
  • GNA13
  • GNAQ
  • GNAS
  • GREM1
  • GRIN2A
  • GRM3
  • GSK3B
  • GSTP1
  • H1-2
  • H2BC5
  • H3-3A
  • H3-5
  • H3C2
  • HAVCR2
  • HCK
  • HDAC2
  • HGF
  • HIF1A
  • HLA-B
  • HLA-C
  • HNF1A
  • HOXB13
  • HRAS
  • HSD3B1
  • HSP90AA1
  • ICOS
  • ICOSLG
  • IDH1
  • IDH2
  • IFNGR1
  • IFNGR2
  • IGF1
  • IGF1R
  • IGF2
  • IKBKE
  • IKZF1
  • IL7R
  • INHBA
  • INPP4A
  • INPP4B
  • INSR
  • IP6K1
  • IRF1
  • IRF2
  • IRF4
  • IRS2
  • JAK1
  • JAK3
  • JUN
  • KDM5A
  • KDM5C
  • KDM6A
  • KDR
  • KEAP1
  • KEL
  • KLF4
  • KLHL6
  • KMT2A
  • KMT2B
  • KMT2C
  • KMT2D
  • KRAS
  • LAG3
  • LATS1
  • LATS2
  • LCK
  • LMO1
  • LRP1B
  • LYN
  • LZTR1
  • MAGI2
  • MAP2K1
  • MAP2K2
  • MAP2K4
  • MAP3K1
  • MAP3K13
  • MAP3K14
  • MAPK1
  • MAPK3
  • MAPK4
  • MAX
  • MCL1
  • MDC1
  • MDM2
  • MDM4
  • MED12
  • MEF2B
  • MEN1
  • MGA
  • MGME1
  • MITF
  • MKI67
  • MLH1
  • MLH3
  • MPL
  • MRE11
  • MSH2
  • MSH3
  • MSH6
  • MST1R
  • MTOR
  • MUC16
  • MUTYH
  • MYC
  • MYCL
  • MYCN
  • MYD88
  • MYOD1
  • NAA11
  • NBN
  • NCOA3
  • NCOR1
  • NF1
  • NF2
  • NFE2L2
  • NFKBIA
  • NKX2-1
  • NOTCH1
  • NOTCH3
  • NOTCH4
  • NRAS
  • NUP93
  • NUTM1
  • OXSR1
  • PAK1
  • PAK3
  • PAK5
  • PALB2
  • PAPPA2
  • PARP1
  • PAX3
  • PAX5
  • PAX7
  • PBRM1
  • PDCD1
  • PDCD1LG2
  • PDK1
  • PDPK1
  • PEG3
  • PGR
  • PHF6
  • PIK3C2B
  • PIK3C2G
  • PIK3C3
  • PIK3CA
  • PIK3CB
  • PIK3CD
  • PIK3CG
  • PIK3R1
  • PIK3R2
  • PIM1
  • PLCG2
  • PLK2
  • PMS1
  • PMS2
  • PNRC1
  • POLD1
  • POLE
  • POLE4
  • PPP2R1A
  • PPP2R2A
  • PRDM1
  • PREX2
  • PRKAA1
  • PRKACA
  • PRKCI
  • PRKDC
  • PRKN
  • PRSS8
  • PSMD4
  • PTCH1
  • PTEN
  • PTPN11
  • PTPRD
  • PXDNL
  • RAC1
  • RAD21
  • RAD50
  • RAD51
  • RAD51B
  • RAD51C
  • RAD51D
  • RAD52
  • RAD54L
  • RASA1
  • RASAL1
  • RB1
  • RBM10
  • RECQL4
  • REL
  • RHEB
  • RHOA
  • RICTOR
  • RIPK4
  • RIT1
  • RNF43
  • ROBO2
  • RPPH1
  • RPS6KB1
  • RPS6KB2
  • RPTOR
  • RSF1
  • RUNX1
  • RUNX1T1
  • SCN8A
  • SDHA
  • SDHAF2
  • SDHB
  • SDHC
  • SDHD
  • SERPINB3
  • SERPINB4
  • SETBP1
  • SETD2
  • SF3B1
  • SIK1
  • SKP2
  • SLIT2
  • SLX4
  • SMAD2
  • SMAD3
  • SMAD4
  • SMARCA4
  • SMARCB1
  • SMARCD1
  • SMO
  • SNCAIP
  • SOCS1
  • SOX10
  • SOX17
  • SOX2
  • SOX9
  • SPEN
  • SPOP
  • SPTA1
  • SRC
  • SRSF2
  • STAG2
  • STAT4
  • STK11
  • SUFU
  • SUZ12
  • SYK
  • TAF1
  • TAOK1
  • TBX3
  • TCF7L1
  • TCF7L2
  • TENT5C
  • TERT
  • TET1
  • TET2
  • TGFBR2
  • TIGIT
  • TMEM127
  • TNFAIP3
  • TNFRSF14
  • TNFRSF18
  • TNFRSF9
  • TOP1
  • TOP2A
  • TPMT
  • TRAF7
  • TRRAP
  • TSC1
  • TSC2
  • TSHR
  • U2AF1
  • VEGFA
  • VHL
  • WRN
  • WT1
  • XPC
  • XPO1
  • XRCC1
  • XRCC2
  • YES1
  • ZBTB2
  • ZFHX4
  • ZNF217
  • ZNRF3
  • ZRSR2

SNP

  • C8orf34
  • EGFR
  • PRDX1
  • TP53
  • ABCB1
  • AKT2
  • APEX1
  • ATM
  • AURKA
  • AUTS2
  • BMP2
  • BMP4
  • CBLB
  • CD44
  • CDA
  • CORO2A
  • CXCL8
  • CYP19A1
  • CYP2C8
  • CYP2D6
  • DPYD
  • DYNC2H1
  • ENG
  • ERCC1
  • F2R
  • GSTP1
  • HAMP
  • HIF1A
  • HSPB1
  • IL13
  • IL1A
  • IL4
  • IL6
  • ITGB2
  • ITGB6
  • LGALS3
  • LIG4
  • LIN28B
  • MGMT
  • MIF
  • MMP1
  • MMP7
  • MPO
  • MSH2
  • MSH3
  • MT2A
  • MTHFR
  • MTRR
  • MUC5B
  • NEIL1
  • NFE2L2
  • NFKB1
  • NFKBIA
  • NOS2
  • NOS3
  • NQO1
  • NR1I2
  • PIK3CA
  • PRDX6
  • PTGS2
  • PTTG1
  • RAD51
  • RECQL
  • REV3L
  • RNASEL
  • RPS6KB2
  • SEMA3C
  • SERPINE1
  • SLC28A3
  • SLC47A1
  • SLCO1B1
  • SOD2
  • TGFB1
  • TGFBR2
  • TNF
  • TRAF3
  • TXNRD2
  • TYMS
  • UGT1A1
  • UMPS
  • VEGFA
  • XPC
  • XRCC1
  • XRCC3
  • XRCC4
  • XRCC5

HD

  • ATM
  • BARD1
  • BRCA1
  • BRCA2
  • BRIP1
  • CDH1
  • CDK12
  • CHEK1
  • CHEK2
  • FANCA
  • FANCL
  • HDAC2
  • PALB2
  • PPP2R2A
  • PTEN
  • RAD51B
  • RAD51C
  • RAD51D
  • RAD54L
  • TP53

FUSIONS

  • ABL1
  • ABR
  • ACADM
  • ADAMTS16
  • AFAP1
  • AFF3
  • AGAP3
  • AGBL4
  • AGGF1
  • AGK
  • AGTRAP
  • AHCYL1
  • AKAP13
  • AKAP9
  • ALAD
  • ALK
  • AMBRA1
  • AMOT
  • AMOTL2
  • ANO3
  • AP1M1
  • AP3B1
  • APIP
  • APOLD1
  • AR
  • ARHGEF2
  • ARMC10
  • ASPSCR1
  • ATF7IP
  • ATG7
  • ATIC
  • ATP1B1
  • ATP6V1D
  • BAG4
  • BAIAP2L1
  • BCAN
  • BCL2L11
  • BCL2L14
  • BCR
  • BICC1
  • BRAF
  • BTBD1
  • BTF3L4
  • C8orf34
  • CACNA2D1
  • CAPZA2
  • CASP7
  • CAV1
  • CBR4
  • CBX5
  • CCAR2
  • CCDC186
  • CCDC6
  • CCDC91
  • CD74
  • CDC27
  • CDK12
  • CEP43
  • CEP72
  • CEP85L
  • CEP89
  • CHTOP
  • CIDEA
  • CIT
  • CLCN6
  • CLDN18
  • CLIP1
  • CLTC
  • CNIH4
  • CNTRL
  • COL14A1
  • COL16A1
  • CREB5
  • CTNNA3
  • CTRC
  • CTTN
  • CUX1
  • CWH43
  • CYSTM1
  • DCTN1
  • DDX21
  • DGCR2
  • DHX15
  • DIAPH1
  • DUSP6
  • DYNC1I2
  • DZANK1
  • EEF1G
  • EGFR
  • EIF1
  • EIF2AK3
  • EIF3L
  • EIF4A2
  • ELAVL3
  • EML4
  • EPS15
  • ERBB2
  • ERBB4
  • ERC1
  • ERG
  • ERLIN2
  • ERP44
  • ESR1
  • ETV1
  • ETV4
  • ETV5
  • ETV6
  • EWSR1
  • EZR
  • F11
  • F11R
  • FAM114A2
  • FAM131B
  • FBXO28
  • FCHSD1
  • FGFR1
  • FGFR1OP2
  • FGFR2
  • FGFR3
  • FGFR4
  • FILIP1
  • FIP1L1
  • FKBP15
  • FLI1
  • FLT3
  • FN1
  • FOXO1
  • GAB2
  • GCGR
  • GHITM
  • GIT2
  • GKAP1
  • GLOD4
  • GOLGA5
  • GOPC
  • GRB10
  • GRIPAP1
  • GTF2I
  • GTF2IRD1
  • GYG1
  • HEY1
  • HIP1
  • HLA-A
  • HNRNPA2B1
  • HSF2BP
  • IKZF3
  • INSL4
  • IRF2BP2
  • JAK2
  • JAKMIP1
  • KCTD8
  • KDM7A
  • KIAA1217
  • KIAA1549
  • KIAA1598
  • KIF5B
  • KIT
  • KLC1
  • KLHL7
  • KLK2
  • LAMC1
  • LIMA1
  • LMNA
  • LOH12CR1
  • LRRC71
  • LSM12
  • LSM14A
  • LUC7L2
  • LZTFL1
  • MAD1L1
  • MAGI3
  • MEF2D
  • MET
  • MGEA5
  • MKRN1
  • MLLT10
  • MORC3
  • MPRIP
  • MSN
  • MYB
  • MYH9
  • MYO18A
  • MYO5A
  • MYRIP
  • MZT1
  • NAB2
  • NACC2
  • NCOA2
  • NCOA4
  • NFASC
  • NFIB
  • NOL4
  • NOS1AP
  • NOTCH2
  • NPM1
  • NR4A3
  • NRAP
  • NRBF2
  • NRG1
  • NRG2
  • NRG3
  • NSD1
  • NTRK1
  • NTRK2
  • NTRK3
  • NUB1
  • NUP214
  • OCIAD1
  • OFD1
  • OXR1
  • PAN3
  • PAPD7
  • PAPSS1
  • PAWR
  • PAX8
  • PCM1
  • PDE7A
  • PDE9A
  • PDGFB
  • PDGFRA
  • PDGFRB
  • PEAR1
  • PGAP3
  • PHC3
  • PHF12
  • PHLDB3
  • PLEKHG6
  • PMEPA1
  • PML
  • POC1B
  • POF1B
  • PPARG
  • PPFIBP1
  • PPHLN1
  • PPL
  • PPP1R1B
  • PPP1R21
  • PPP4R3B
  • PRDX1
  • PRKAR1A
  • PRKAR2A
  • PSMB3
  • PSPH
  • PTGFRN
  • PWWP2A
  • QKI
  • RAB3IL1
  • RABGAP1L
  • RAD18
  • RAF1
  • RANBP2
  • RARA
  • RBMS3
  • RBPMS
  • REG4
  • RET
  • RNF130
  • RNF213
  • ROCK1
  • ROS1
  • RPL3
  • RTN4RL1
  • SARS
  • SCP2
  • SCYL3
  • SDC4
  • SEC22B
  • SEC31A
  • SEC61G
  • SEPT10
  • SEPT14
  • SEPTIN3
  • SHROOM3
  • SHTN1
  • SIL1
  • SLC12A7
  • SLC34A2
  • SLC3A2
  • SLC43A2
  • SLMAP
  • SMARCE1
  • SND1
  • SORBS1
  • SPAG17
  • SPECC1L
  • SQSTM1
  • SS18
  • SSBP2
  • SSX1
  • SSX2
  • ST7
  • STARD3
  • STAT3
  • STAT6
  • STK26
  • STMN2
  • STRN
  • STRN3
  • TACC1
  • TACC2
  • TACC3
  • TANK
  • TATDN1
  • TAX1BP1
  • TBC1D1
  • TBC1D2
  • TBL1XR1
  • TEAD2
  • TFE3
  • TFG
  • TLCD2
  • TLE4
  • TLE5
  • TMEFF2
  • TMEM106B
  • TMEM165
  • TMPRSS2
  • TP53
  • TP73
  • TPD52L1
  • TPM1
  • TPM3
  • TPM4
  • TPR
  • TRAF1
  • TRAF2
  • TRAK1
  • TRIM24
  • TRIM27
  • TRIM33
  • TRIM63
  • TXLNA
  • USP10
  • USP8
  • UST
  • VCAN
  • VCL
  • VIM
  • VOPP1
  • VSTM2A
  • WAC
  • WDCP
  • WIPF2
  • WNK2
  • XXYLT1
  • YWHAE
  • ZAN
  • ZC3HAV1
  • ZCCHC8
  • ZMYM2
  • ZMYM4
  • ZNF34
  • ZNF485
  • ZNF703
  • ZSCAN30
  • FUS
  • PAX3
  • PAX7

CNV

  • EGFR
  • ERBB2
  • FGFR1
  • FGFR2
  • FGFR3
  • MET
  • NTRK3
  • PDGFRA
  • RET
  • AKT2
  • AKT3
  • AURKA
  • CCND1
  • CD274
  • CDK4
  • CDK6
  • FGF19
  • FGF3
  • HGF
  • IGF1R
  • MAPK1
  • MDM2
  • MDM4
  • MYC
  • PGR
  • PIK3CA
  • RICTOR
  • SMO
  • TOP2A

Specifications

Target regions DNA: 571 genes; RNA: 2660 genes
Alterations detected DNA: SNVs/Indels, Fusions, CNV, TMB, MSI, HRD; RNA: Fusions, GeneExp, GEP, TME, EBV
Data output per sample DNA: 10Gb; RNA: 2Gb
Sequencer Illumina NovaSeq 6000; NextSeq 500/550

AmoyDx® BRCA Pro Panel

Technology
NGS

Tumor
Breast cancer/ Ovarian cancer

Certificate

 

AmoyDx® BRCA Pro Panel

BRCA1/2 (BReast CAncer gene1/2), commonly referred to as tumor suppressor genes, play a pivotal role in regulating DNA damage repair via homologous recombination. Pathogenic mutations, whether germline or somatic, in BRCA1/2 can lead to tumors characterized by significant genomic instability. Individuals harboring pathogenic variants in BRCA1 or BRCA2 genes are at heightened risk for various cancer types, including breast, ovarian, prostate, pancreatic, and melanoma.

The AmoyDx® BRCA Pro Panel comprehensively covers all protein coding regions, intron/exon boundaries, select introns, and UTR regions of the BRCA1 and BRCA2 genes. This panel enables the detection of germline/somatic SNVs/Indels as well as germline large rearrangements (LRs) from either whole blood or FFPE tissue samples.

Mutations

LR

  • BRCA1
  • BRCA2

SNV/INDELS

  • BRCA1
  • BRCA2

Detection of SNV,InDel and LR

Decentralized kit solution with ease of use

Fast turnaround time and cost-effective

Streamlined one-tube workflow

Specifications

Target regions All coding regions of BRCA1/2 genes, exon-intron boundaries, some intron and UTR regions
Alterations detected SNV & Indel (somatic/germline), LR (germline)
Sample type DNA from FFPE tissue, whole blood
DNA input Optimal 50ng (minimum 30ng)
Data output per sample 0.06 Gb for germline variants
0.3 Gb for somatic variants
Sequencing type PE150
Sequencer Illumina MiSeqDx, NextSeq 500, NextSeq 550Dx
TAT for library prep 5 hours (hands-on time <1 hour )
TAT from sample to report 3 days

Technology

The AmoyDx HANDLE® technology is a proprietary amplicon-based method for NGS library preparation.
It offers a time-saving and cost-effective protocol that can be completed within 5 hours, requiring just about 1 hour of hands-on time.

During the library construction process, each individual DNA molecule is tagged with a unique molecular index (UMI) at both ends. This feature enables high sensitivity in variant detection by eliminating any library amplification and sequencing bias.

The probe consists of an extension arm and a ligation arm, both complementary to the target gene region.
Target-specific probes simultaneously hybridize to the DNA/cDNA fragment, forming a circular structure with the intended target captured between the probes. Subsequently, remaining linear probes, single-strand, and double-strand DNA are digested, leaving only the target circular DNA for PCR amplification to form the final library.

Sequencing data generated with AmoyDx NGS products can be conveniently and securely analyzed using the AmoyDx NGS Data Analysis System (ANDAS). The ANDAS Data Analyzer consists of a local server and preinstalled ANDAS software equipped with specific analysis modules tailored for analyzing data from various AmoyDx NGS products.

The ANDAS server is installed within the same local network as the sequencer, providing the laboratory with complete control over data and security.
This ensures the protection of valuable sequencing data and downstream analysis results, including sensitive patient information. Accessible via a computer within the network, the ANDAS server and its preinstalled software offer an intuitive user interface for swift and straightforward analysis generation.

AmoyDx® HANDLE Classic NGS Panel

Technology
NGS

Tumor
Pan-tumor/ Non-small cell lung cancer/ Colorectal cancer/ Thyroid cancer/ Gastric(Stomach) cancer

Certificate

 

AmoyDx® HANDLE Classic NGS Panel

Critical biomarkers guiding pan-cancer targeted therapy have emerged, emphasizing the importance of detecting multiple gene mutations in cancer patients for precise and effective treatment. The AmoyDx HANDLE Classic Panel encompasses 40 key solid tumor genes, enabling the detection of common mutations to support clinical therapeutic decisions with rapid turnaround time (TAT).

Mutations

SNV/INDELS

  • AKT1
  • ALK
  • BRAF
  • CTNNB1
  • DDR2
  • EGFR
  • ERBB2
  • ESR1
  • FGFR1
  • FGFR2
  • FGFR3
  • FGFR4
  • HRAS
  • IDH1
  • IDH2
  • KEAP1
  • KIT
  • KRAS
  • MAP2K1
  • MET
  • NFE2L2
  • NRAS
  • NTRK1
  • NTRK2
  • NTRK3
  • PDGFRA
  • PIK3CA
  • POLE
  • PTEN
  • RB1
  • RET
  • ROS1
  • STK11
  • TP53

SNP

  • DPYD
  • UGT1A1

FUSIONS

  • ALK
  • FGFR1
  • FGFR2
  • FGFR3
  • MET
  • NTRK1
  • NTRK2
  • NTRK3
  • RET
  • ROS1
  • NRG1

CNV

  • ERBB2
  • MET
  • CDK4
  • MYC
  • NKX2-1

Target 40 clinically actionable genes plus MSI

Detection of SNV, Indel, fusion, CNV and MSI

Fast turnaround time within 3 days

Automatic and secure data analysis

Specifications

Sample type FFPE
Alterations detected SNV, InDel, Fusion, CNV, MSI
DNA input minimum 50 ng DNA and 30 ng RNA

AmoyDx® Essential NGS Panel

Technology
NGS

Tumor
Non-small cell lung cancer/ Colorectal cancer

Certificate

 

AmoyDx® Essential NGS Panel

The assay is tailored to detect prevalent mutations in 10 genes: EGFR, ALK, ROS1, RET, KRAS, NRAS, PIK3CA, BRAF, HER2, and MET, in patients with non-small cell lung cancer (NSCLC) and colorectal cancer (CRC), using FFPE or Liquid Biopsy samples. Test outcomes are provided for clinical reference exclusively. Clinicians should evaluate the results in conjunction with the patient’s medical status, drug indications, treatment response, and other laboratory test findings comprehensively.

Mutations

SNV/INDELS

  • EGFR
  • ALK
  • ROS1
  • RET
  • KRAS
  • NRAS
  • PIK3CA
  • BRAF
  • HER2
  • MET

CNV

  • MET

FUSIONS

  • ALK
  • ROS1
  • RET

Fast turnaround time within 1 week

Automatic and secure data analysis

Target 10 driver genes for NSCLC/CRC

Detection of SNV, InDel, fusion, CNV

Specifications

Sample type FFPE, the whole blood
Alterations detected SNV, InDel, Fusion, CNV,
DNA input FFPE: optimal 100 ng
cfDNA: ≥10 ng (optimal 30 ng)

AmoyDx® HANDLE HRR NGS Panel

Technology
NGS

Tumor
Breast cancer/ Ovarian cancer/ Prostate cancer/ Pancreatic cancer

Certificate

 

AmoyDx® HANDLE HRR NGS Panel

The AmoyDx® HANDLE HRR NGS Panel facilitates the detection of somatic and germline variants across 27 genes within the Homologous Recombination Repair (HRR) pathway, along with 5 tumor driver genes.

Mutations

SNV/INDELS

  • ATM
  • BARD1
  • BRCA1
  • BRCA2
  • BRIP1
  • CDH1
  • CDK12
  • CHEK1
  • CHEK2
  • FANCA
  • FANCL
  • HDAC2
  • PALB2
  • PPP2R2A
  • PTEN
  • RAD51B
  • RAD51C
  • RAD51D
  • RAD54L
  • TP53

LR

  • BRCA1
  • BRCA2

Secure data analysis and interpretation

Detection of SNV, InDel and germline LR for BRCA1/BRCA2

Fast turnaround time and cost-effective

Streamlined one-tube workflow

Specifications

Target regions 27 HRR genes: All coding regions, exon-intron boundaries of AR, ATM, ATR, BARD1, BRCA1, BRCA2, BRIP1, CDH1, CDK12, CHEK1, CHEK2, ESR1, FANCA, FANCL, HDAC2, HOXB13, MRE11, NBN, PALB2, PPP2R2A, PTEN, RAD51B, RAD51C, RAD51D, RAD54L, STK11 and TP53.
5 driver genes (BRAF, ERBB2, KRAS, NRAS, PIK3CA): hotspot regions
Alterations detected SNV, Indel (somatic/germline), LR (germline for BRCA1/2)
Sample type Fresh-frozen/FFPE tissue, whole blood
DNA input Optimal 100ng (FFPE/fresh tissue ≥30ng, whole blood ≥20ng)
Data output per sample 0.35 Gb for germline variants, 0.7 Gb for somatic variants
Sequencing type PE150
Sequencer Illumina iSeq 100, MiniSeq, MiSeq, NextSeq 500, NovaSeq 6000
TAT for library prep 5 hours (hands-on time <1 hour )
TAT from sample to report 3 days

AmoyDx® Pan Lung Cancer PCR Panel

Technology
PCR

Tumor
Non-small cell lung cancer

Certificate

 

AmoyDx® Pan Lung Cancer PCR Panel

ONE & ONLY PCR Panel With 167 Variants Across 11 Target Genes in a Single Run

The AmoyDx® Pan Lung Cancer PCR Panel (PLC Panel) is a tissue-based, real-time, qPCR assay for in vitro diagnostics (IVD). The PLC Panel enables qualitative detection of up to 167 variants (85 DNA mutations and 82 RNA fusions) in 11 genes (EGFR, ALK, ROS1, KRAS, BRAF, HER2, RET, MET, NTRK1, NTRK2, and NTRK3), identifying all NCCN recommended biomarkers in a single PCR run. The PLC Panel is intended to assist in identifying clinically relevant biomarkers for patients with non-small cell lung cancer (NSCLC) who may be eligible for approved targeted therapies at minimal cost. The kit is for in vitro diagnostic use and intended to be used by trained professionals in a laboratory environment.

Clinical Performance

The clinical performance of PLC Panel was validated in a concordance study by LC-SCRUM-Japan.1 Results were highly concordant with the reference NGS assay for alterations (fusion, indels, SNVs) across 11 actionable biomarkers.

1. Matsumoto, S., et. al. Prospective concordance study of a multi-gene PCR assay and NGS for the detection of targetable gene alterations in lung cancer [abstract] in Journal of Thoracic Oncology. 2021 March; 16:3(S690): WCLC; 2020. Abstract P89.06.

Mutations

SNV/INDELS

  • EGFR

FUSIONS

  • ALK
  • RET
  • ROS1
  • NTRK1
  • NTRK2
  • NTRK3
  • MET

SNV

  • KRAS
  • BRAF

INDELS

  • HER2

Fast turnround time within 1 day

Target 167 variants (85 DNA mutations and 82 RNA fusions) in 11 biomarkers

Cost-effective

Higher detection rate and higher success rate

Specifications

Tests/kit 8
Instrument QuantStudio™ 5, LightCycler® 480 II, cobas z 480, Bio-Rad CFX96, SLAN-96S
Sample requirement FFPE or fresh/frozen tissue minimum 60 ng DNA; minimum 120 ng RNA

AmoyDx® Myeloid Blood Cancer Panel

Technology
NGS

Tumor
Acute myeloid leukemia/Chronic myeloid leukemia

Certificate

AmoyDx® Myeloid Blood Cancer Panel

The AmoyDx® Myeloid Blood Cancer Panel employs next-generation sequencing (NGS) technology to qualitatively detect and identify single nucleotide variants (SNVs), insertions and deletions (InDels), and gene fusions within 55 genes associated with myeloid leukemia. This assay utilizes DNA and RNA extracted from bone marrow aspirate specimens obtained from patients diagnosed with acute myeloid leukemia or chronic myeloid leukemia.

Single Assay Solution for Detecting Variants Associated with Acute Myeloid Leukemia (AML) and Chronic Myeloid Leukemia (CML) Using Both DNA & RNA

Specifications

Sample type Bone Marrow
Alterations detected SNV、Indel、Fusion-96S
Sequencer NovaSeq 6000, NextSeq 500/550, MiSeq, MiSeqDx
TAT from sample to report 3 days

Mutations

SNV/INDELS

  • ABL1
  • ASXL1
  • BCOR
  • BRAF
  • CALR
  • CBFB
  • CBL
  • CEBPA
  • CREBBP
  • CSF3R
  • CTCF
  • DIS3
  • DNMT3A
  • ETV6
  • EZH2
  • FBXW7
  • FLT3
  • GATA1
  • GATA2
  • IDH1
  • IDH2
  • IKZF1
  • JAK2
  • JAK3
  • KIT
  • KMT2A
  • KRAS
  • MAX
  • MPL
  • MYC
  • MYD88
  • NF1
  • NPM1
  • NRAS
  • NUP98
  • PDGFRA
  • PHF6
  • PTPN11
  • RB1
  • RIT1
  • RUNX1
  • SETBP1
  • SF3B1
  • SRSF2
  • STAG2
  • TET2
  • TP53
  • U2AF1
  • WT1
  • ZRSR2
  • ZRSR2

FUSIONS

  • ABL1
  • CBFB
  • CREBBP
  • ETV6
  • JAK2
  • KMT2A
  • MLLT10
  • NPM1
  • NUP98
  • NUP214
  • PDGFRA
  • RUNX1
  • RARA
  • STIL
  • TCF3

AmoyDx® Comprehensive Panel

Technology
NGS

Tumor
Pan-tumor/ Non-small cell lung cancer/ Colorectal cancer/ Breast cancer/ Thyroid cancer/ Gastric(Stomach) cancer

Certificate

AmoyDx® Comprehensive Panel

The AmoyDx® Comprehensive Panel is a next-generation sequencing-based test capable of detecting a wide range of alterations.

Tumor microsatellite instability (MSI) or mismatch repair (MMR) status serves as a predictive pan-cancer marker for response to immune checkpoint inhibitor therapy. NGS-based MSI testing across various cancer types offers both flexibility and accuracy, facilitating the incorporation of MSI status into decision-making processes and prediction of immune checkpoint blockade therapy efficacy.
Genetic polymorphisms in genes encoding bolizing enzymes and drug transporters can impact drug efficacy and toxicity. Identifying these genetic variations can help identify individuals predisposed to a high risk of toxicity and low response to standard doses of anti-cancer drugs.
Mutations in the BRCA1 and BRCA2 genes confer genetic predisposition to breast and ovarian cancers. The AmoyDx® Comprehensive Panel also detects BRCA1/2 mutations, allowing for the identification of candidates suitable for PARP inhibitor therapy.

Mutations

SNV/INDELS

  • AKT1
  • AKT2
  • AKT3
  • ALK
  • APC
  • AR
  • ARAF
  • ARID1A
  • ATM
  • ATR
  • AURKA
  • BAP1
  • BCL2L11
  • BRAF
  • BRCA1
  • BRCA2
  • CCND1
  • CCNE1
  • CD274
  • CDK12
  • CDK4
  • CDK6
  • CDKN2A
  • CDKN2B
  • CREBBP
  • CTNNB1
  • DDR2
  • EGFR
  • EIF1AX
  • EPAS1
  • EPCAM
  • ERBB2
  • ERBB3
  • ERBB4
  • ESR1
  • ETS2
  • FANCA
  • FBXW7
  • FGF19
  • FGF3
  • FGFR1
  • FGFR2
  • FGFR3
  • FGFR4
  • FLCN
  • FLT3
  • GNAS
  • HIF1A
  • HRAS
  • IDH1
  • IDH2
  • IGF1R
  • JAK1
  • JAK2
  • JAK3
  • KDM5C
  • KDR
  • KIT
  • KRAS
  • MAP2K1
  • MAPK1
  • MET
  • MLH1
  • MRE11
  • MSH2
  • MSH6
  • MTOR
  • MYC
  • NF1
  • NF2
  • NOTCH1
  • NRAS
  • NRG1
  • NTRK1
  • NTRK2
  • NTRK3
  • PALB2
  • PAX8
  • PDCD1
  • PDGFRA
  • PGR
  • PIK3CA
  • PIK3R1
  • PMS2
  • POLD1
  • POLE
  • PSMD4
  • PTCH1
  • PTEN
  • RAF1
  • RASA1
  • RASAL1
  • RB1
  • RET
  • RICTOR
  • RIT1
  • ROS1
  • RSF1
  • SF3B1
  • SMAD4
  • SMARCA4
  • SMO
  • STK11
  • TERT
  • TOP2A
  • TP53
  • TSC1
  • TSC2
  • TSHR
  • VHL

SNP

  • TP53
  • ABCB1
  • C8orf34
  • CDA
  • CYP19A1
  • CYP2D6
  • DPYD
  • DYNC2H1
  • ERCC1
  • GSTP1
  • MTHFR
  • MTRR
  • SEMA3C
  • SLC28A3
  • SOD2
  • UGT1A1
  • UMPS
  • XPC
  • XRCC1

FUSIONS

  • ALK
  • BRAF
  • FGFR1
  • FGFR2
  • FGFR3
  • NRG1
  • NTRK1
  • NTRK2
  • NTRK3
  • PAX8
  • RET
  • ROS1

CNV

  • AKT2
  • AKT3
  • AURKA
  • CCND1
  • CCNE1
  • CD274
  • CDK4
  • CDK6
  • EGFR
  • EPAS1
  • ERBB2
  • FGF19
  • FGF3
  • FGFR1
  • FGFR2
  • FGFR3
  • HIF1A
  • IGF1R
  • MAPK1
  • MET
  • MYC
  • NTRK3
  • PDGFRA
  • PGR
  • PIK3CA
  • PSMD4
  • RET
  • RICTOR
  • RSF1
  • SMO
  • TOP2A

Target 128 genes on tumor actionable variants

Detection of SNV, Indel, fusion, CNV

Fast turnaround time within 1 week

Automatic and secure data analysis

Specifications

Target regions 128 genes and MSI
Alterations detected SNV, InDel, Fusion, CNV, SNP, MSI
CNV and MSI detection are for tissue sample only.96S
Sample type FFPE tumor tissue, liquid biopsy
DNA input FFPE DNA: optimal 100 ng (minimum 50 ng)
Plasma cfDNA: optimal 30 ng (minimum 10 ng)
Sequencer Illumina NextSeq 500, NovaSeq 6000
TAT for library preparation 2 days (hands-on time: 4 hours )
TAT from sample to report 5 days

AmoyDx® PD-L1 (E1L3N) Assay

Technology
IHC

Tumor
Pan-tumor/ Non-small cell lung cancer/ Gastric(Stomach) cancer/ Gastroesophageal junction adenocarcinoma

Certificate

AmoyDx® PD-L1 (E1L3N) Assay

AmoyDx® PD-L1 (E1L3N) Assay​ is a qualitative immunohistochemistry (IHC) assay using monoclonal rabbit anti-PD-L1 clone E1L3N intended for use in the detection of PD-L1 protein in FFPE tissue from multiple tumor types.

Multi-Platform Compatibility

PPA: Positive Percent Agreement; NPA: Negative Percent Agreement; OPA: Overall Percent Agreement

 

Excellent Concordance

Note: PD-L1 protein is determined using Tumor Proportion Score (TPS) in non-small cell lung cancer (NSCLC), and Combined Positive Score (CPS) in other cancer types.
CDx Assay A is a commercial IHC assay using recombinant mouse monoclonal antibody; CDx Assay B is a commercial IHC assay using recombinant rabbit monoclonal antibody

AmoyDx PD-L1 (E1L3N) assay is a reliable and cost-effective way to evaluate PD-L1 status in multiple tumor types

A comprehensive pan-tumor analysis of PD-L1 using AmoyDx PD-L1 (E1L3N) assay

GC/GEJ: Gastric/gastroesophageal junction cancer, CRC: Colorectal cancer, NSCLC: Non-small cell lung cancer
Source: published at ASCO 2023. DOI: 10.1200/JCO.2023.41.16_suppl.2656

Specifications

Storage & Shelf-life 2℃-8℃ for 12 months
Size 6mL/bottle
Instrument Leica BOND-MAX; BOND-III; DAKO Autostainer Link 48; Ventana BenchMark ULTRA

AmoyDx® Automated Result Analysis System(ARAS)

Technology
PCR

Tumor
Pan-tumor

Certificate

AmoyDx® Automated Result Analysis System(ARAS)

AmoyDx® Automated Result Analysis System (ARAS), an advanced software designed to automate the interpretation of AmoyDx PCR data, elevating your laboratory workflow to new heights. ARAS is crafted to streamline PCR data analysis, delivering timely and comprehensive results with a focus on precision and efficiency.

 

Seamless Data Analysis Workflow in Just 1 Minute

Experience the future of data analysis with ARAS, where efficiency meets precision, delivering results in minutes.

ARAS Supported Products and Instruments

AmoyDx® Pan Lung Cancer PCR Panel QuantStudio5, LightCycler480 II, cobas z 480, SLAN-96S,
BIOER QuantGene9600, BioRad CFX96
Super-ARMS® EGFR Mutation Detection Kit LightCycler480 II, cobas z 480, SLAN-96S, ABI7500, Mx3000P
AmoyDx® Microsatellite Instability (MSI) Detection Kit LightCycler480 II, cobas z 480, SLAN-96S
AmoyDx® KRAS/NRAS/BRAF Mutations Detection Kit LightCycler480 II, cobas z 480, SLAN-96S, ABI7500, Mx3000P
AmoyDx® EGFR 29 Mutations Detection Kit LightCycler480 II, cobas z 480, SLAN-96S, BioRad CFX96, ABI7500, Mx3000P
AmoyDx® KRAS Mutation Detection Kit LightCycler480 II, cobas z 480, SLAN-96S, BioRad CFX96, ABI7500, Mx3000P
AmoyDx® Multi-Gene Mutations Detection Kit LightCycler480 II, cobas z 480, SLAN-96S, ABI7500, Mx3000P

Technology

Easy to use

Fast

Secure

Compatibility

AmoyDx® Automated Result Analysis System (ARAS), an advanced software designed to automate the interpretation of AmoyDx PCR data, elevating your laboratory workflow to new heights. ARAS is crafted to streamline PCR data analysis, delivering timely and comprehensive results with a focus on precision and efficiency.

Explore our online educational web-based ARAS software at http://support.amoydx.com/, designed for training, evaluation, and troubleshooting.

AmoyDx® HANDLE Melanoma NGS Panel

Technology
NGS

Tumor
Melanoma

Certificate

The AmoyDx® HANDLE Melanoma NGS Panel is an advanced next-generation sequencing (NGS) assay designed to qualitatively detect single nucleotide variants (SNVs), insertions and deletions (InDels) within pivotal melanoma tumor genes, utilizing DNA extracted from FFPE tumor tissue specimens.

Comprehensive analysis of 9 key genes

Superior Detection Rate

Short turnaround time within 3 days

Cost-effective & Broad Compatibility

Mutations

SNV/INDELS

  • BRAF
  • CTNNB1
  • GNA11
  • GNAQ
  • HRAS
  • KIT
  • KRAS
  • NRAS

SNV

  • TERT

Specifications

Sample type FFPE tissue
Alterations Detected SNV, InDel
DNA input 30-100 ng (50 ng is recommended)
Data output per sample 25 Mb/sample, (0.025 GB)
Sequencer Illumina NextSeq 500/550, MiSeq/MiSeqDx, iSeq 100 (PE150)
AT for library preparation 5 hours (hands-on time 1 hour)
TAT from sample to report 3 days

AmoyDx® ALK Gene Fusions and ROS1 Gene Fusions Detection Kit

Technology
PCR

Tumor
Non-small cell lung cancer

Certificate

 

AmoyDx® ALK Gene Fusions and ROS1 Gene Fusions Detection Kit

AmoyDx® ALK and ROS1 Gene Fusions Detection Kit is a Real-Time PCR assay. The kit enables qualitative detection of up to 14 ALK gene fusions and 14 ROS1 gene fusions in human RNA extracted from FFPE tumor tissue. It is intended to aid in identifying ALK and ROS1 fusion status for patients with non-small cell lung cancer (NSCLC) who may be eligible for approved targeted therapies. The kit is for in vitro diagnostic use and intended for use by trained professionals in a laboratory environment.

One-step assay with simple operation

Low sample input requirement

Fast turnaround time of 1.5 hours

High sensitivity of 125-250 cp/rxn

Specifications

Tests/kit 8 (Pre-loaded)
Instrument Stratagene Mx3000P™, ABI 7500, SLAN-96S
Shelf-life 12 months

AmoyDx® Multi-Gene Mutations Detection Kit

Technology
PCR

Tumor
Non-small cell lung cancer

Certificate

 

AmoyDx® Multi-Gene Mutations Detection Kit

AmoyDx® Multi-Gene Mutations Detection Kit is a real-time PCR assay. The kit enables qualitative detection of up to 118 variants across 9 genes (KRAS, NRAS, BRAF, PIK3CA, ROS1, RET, HER2, ALK and EGFR). It is designed to assist in identifying clinically relevant biomarkers for patients with non-small cell lung cancer (NSCLC) who may be eligible for approved targeted therapies. The kit is for in vitro diagnostic use and intended for use by trained professionals in a laboratory environment.

Target 9 biomarkers in a single PCR run

Fast turnaround time

Low sample input requirement

Compatible with mainstream real-time PCR instruments

Specifications

Tests/kit 6 (Pre-loaded)
Instrument Stratagene Mx3000P™, ABI 7500, LightCycler480 II, cobas® z480, SLAN-96S
Shelf-life 8 months

AmoyDx® EML4-ALK Fusion Gene Detection Kit

Technology
PCR

Tumor
Non-small cell lung cancer

Certificate

 

AmoyDx® EML4-ALK Fusion Gene Detection Kit

AmoyDx® EML4-ALK Fusion Gene Detection Kit is a real-time PCR assay. The kit facilitates the qualitative detection of up to 21 EML4-ALK fusions in human RNA extracted from formalin-fixed paraffin-ded (FFPE) tumor tissue of NSCLC patients.

High sensitivity of 125-250 cp/rxn

One-step assay with simple operation

Low sample input requirement

Fast turnaround time of 1.5 hours

Specifications

Tests/kit 24 (Bulk)
Instrument Stratagene Mx3000P™, ABI 7500, LightCycler480 II, Bio-Rad CFX96, Rotor-Gene Q/6000 (72 wells), SLAN-96S
Shelf-life 12 months

AmoyDx® EGFR/ALK/ROS1 Mutations Detection Kit

Technology
PCR

Tumor
Non-small cell lung cancer

Certificate

AmoyDx® EGFR/ALK/ROS1 Mutations Detection Kit

AmoyDx® EGFR/ALK/ROS1 Mutations Detection Kit is a real-time PCR assay. The kit enables the qualitative detection of up to 58 variants in EGFR, ALK, and ROS1 genes in human DNA extracted from formalin-fixed paraffin-ded (FFPE) tissue samples of NSCLC patients. The kit is for research use only (RUO). Not for use in diagnostic procedures.

Target 3 biomarkers in a single PCR run

Fast turnaround time

Low sample input requirement

Compatible with mainstream real-time PCR instruments

Specifications

Tests/kit 8 (Pre-loaded)
Instrument Stratagene Mx3000P™, ABI 7500, SLAN-96S
Shelf-life 8 months

AmoyDx® MET Mutation Detection Kit

Technology
PCR

Tumor
Non-small cell lung cancer

Certificate

AmoyDx® MET Mutation Detection Kit

AmoyDx® MET Mutation Detection Kit is a real-time PCR assay. This kit facilitates the qualitative detection of METexon14 skipping mutation in human RNA extracted from NSCLC formalin-fixed paraffin-ded (FFPE) tissue samples. The kit is intended for research use only (RUO) and is not intended for diagnostic procedures.

High sensitivity of 125-250 cp/rxn

One-step assay with simple operation

Fast turnaround time of 1.5 hours

Low sample input requirement

Specifications

Tests/kit 24 (Bulk)
Instrument Stratagene Mx3000P™, ABI7500, LightCycler480 II, SLAN-96S, Rotor-Gene Q (72 wells)
Shelf-life 12 months

AmoyDx® HER2 Mutation Detection Kit

Technology
PCR

Tumor
Non-small cell lung cancer

Certificate

AmoyDx® HER2 Mutation Detection Kit

AmoyDx® HER2 Mutation Detection Kit is a real-time PCR assay designed for qualitative detection of up to 13 variants in human DNA extracted from formalin-fixed paraffin-ded (FFPE) tissue samples. It is intended for research use only (RUO) and is not intended for diagnostic procedures.

Fast turnaround time of 1.5 hours

Low sample input requirement

Compatible with mainstream real-time PCR instruments

High sensitivity of 1%

Specifications

Tests/kit 24 (Bulk)
Instrument Stratagene Mx3000P™, ABI 7500, ABI 7900HT, ABI StepOnePlus, LightCycler480 II, Bio-Rad CFX96, SLAN-96S, Rotor-Gene Q/6000 (72 wells)
Shelf-life 12 months

AmoyDx® RET Gene Fusions Detection Kit

Technology
PCR

Tumor
Non-small cell lung cancer

Certificate

AmoyDx® RET Gene Fusions Detection Kit

AmoyDx® RET Gene Fusions Detection Kit is a real-time PCR assay designed for qualitative detection of up to 9 RET gene fusions in human RNA extracted from formalin-fixed paraffin-ded (FFPE) tissue samples. It is intended for research use only (RUO) and is not intended for diagnostic procedures.

High sensitivity of 125-250 cp/rxn

One-step assay with simple operation

Fast turnaround time of 1.5 hours

Low sample input requirement

Specifications

Tests/kit 12 (Bulk)
Instrument Stratagene Mx3000P™, ABI7500, LightCycler480 II, Bio-Rad CFX96, SLAN-96S, Rotor-Gene Q (72 wells)
Shelf-life 12 months

AmoyDx® KRAS Mutation Detection Kit

Technology
PCR

Tumor
Non-small cell lung cancer

Certificate

 

AmoyDx® KRAS Mutation Detection Kit

AmoyDx® KRAS Mutation Detection Kit is a real-time PCR assay for in vitro diagnostics (IVD). This kit enables qualitative detection of up to 19 somatic mutations of the KRAS gene in human DNA extracted from formalin-fixed paraffin-ded (FFPE) tissue samples. It is intended to aid in the identification of KRAS mutation status for colorectal cancer patients who may be eligible for approved targeted therapies. The kit is for in vitro diagnostic use and is intended to be used by trained professionals in a laboratory environment.

High sensitivity of 1%

Fast turnaround time of 1.5 hours

Low sample input requirement

Compatible with mainstream real-time PCR instruments

Specifications

Tests/kit 6 (Pre-loaded) / 24 (Bulk)
Instrument Stratagene Mx3000P™, ABI 7500, LightCycler480 II, Bio-Rad CFX96, SLAN-96S, cobas® z480
Shelf-life 12 months

AmoyDx® KRAS/NRAS Mutations Detection Kit

Technology
PCR

Tumor
Non-small cell lung cancer

Certificate

 

AmoyDx® KRAS/NRAS Mutations Detection Kit

AmoyDx® KRAS/NRAS Mutations Detection Kit is a real-time PCR assay for in vitro diagnostics (IVD). This kit enables qualitative detection of up to 32 somatic mutations of the KRAS and NRAS genes in human DNA extracted from formalin-fixed paraffin-ded (FFPE) tissue samples. It is intended to aid in the identification of KRAS and NRAS mutation status for colorectal cancer patients who may be eligible for approved targeted therapies. The kit is for in vitro diagnostic use and is intended to be used by trained professionals in a laboratory environment.

Fast turnaround time of 1.5 hours

Low sample input requirement

Compatible with mainstream real-time PCR instruments

High sensitivity of 1%

Specifications

Tests/kit 6 (Pre-loaded) / 24 (Bulk)
Instrument Stratagene Mx3000P™, ABI 7500, LightCycler480 II, Bio-Rad CFX96, SLAN-96S
Shelf-life 12 months

AmoyDx® NRAS Mutation Detection Kit

Technology
PCR

Tumor
Non-small cell lung cancer

Certificate

 

AmoyDx® NRAS Mutation Detection Kit is a real-time PCR assay for in vitro diagnostics (IVD). The kit enables qualitative detection of up to 16 somatic mutations of the NRAS gene in human DNA extracted from formalin-fixed paraffin-ded (FFPE) tissue samples. The kit is intended to aid in the identification of NRAS mutation status for colorectal cancer patients who may be eligible for approved targeted therapies. It is for in vitro diagnostic use and intended to be used by trained professionals in a laboratory environment.

High sensitivity of 1%

Fast turnaround time of 1.5 hours

Low sample input requirement

Compatible with mainstream real-time PCR instruments

Specifications

Tests/kit 8 (Pre-loaded) / 24 (Bulk)
Instrument Stratagene Mx3000P™, ABI 7500, LightCycler480 II, Bio-Rad CFX96, SLAN-96S
Shelf-life 12 months

AmoyDx® KRAS/NRAS/BRAF Mutations Detection Kit

Technology
PCR

Tumor
Colorectal cancer

Certificate

 

AmoyDx® KRAS/NRAS/BRAF Mutations Detection Kit

AmoyDx® KRAS/NRAS/BRAF Mutations Detection Kit is a real-time PCR assay. The kit enables qualitative detection of up to 31 somatic mutations of the KRAS, NRAS, and BRAF genes in human DNA extracted from formalin-fixed paraffin-ded (FFPE) tissue samples. It is intended to aid in the identification of KRAS, NRAS, and BRAF mutation status for colorectal cancer patients who may be eligible for approved targeted therapies. The kit is for in vitro diagnostic use and intended to be used by trained professionals in a laboratory environment.

High sensitivity of 1%

Fast turnaround time of 1.5 hours

Low sample input requirement

Compatible with mainstream real-time PCR instruments

Specifications

Tests/kit 6 (Pre-loaded)
Instrument Stratagene Mx3000P™, ABI 7500, LightCycler480 II, SLAN-96S
Shelf-life 8 months

AmoyDx® BRAF Mutation Detection Kit (V2)

Technology
PCR

Tumor
Non-small cell lung cancer/ Colorectal cancer

Certificate

AmoyDx® BRAF Mutation Detection Kit (V2)

AmoyDx® BRAF Mutation Detection Kit (V2) is a real-time PCR assay. The kit enables qualitative detection of up to 7 somatic mutations of BRAF gene in human DNA extracted from formalin-fixed paraffin-ded (FFPE) tissue samples. The kit is for research use only (RUO). Not for use in diagnostic procedures.

High sensitivity of 1%

Fast turnaround time of 1.5 hours

Low sample input requirement

Compatible with mainstream real-time PCR instruments

Specifications

Tests/kit 24 (Bulk)
Instrument Stratagene Mx3000P™, SLAN-96S, Rotor-Gene Q (72 wells), Bio-Rad CFX96
Shelf-life 8 months

AmoyDx® Microsatellite Instability (MSI) Detection Kit

Technology
PCR

Tumor
Colorectal cancer

Certificate

AmoyDx® Microsatellite Instability (MSI) Detection Kit

The AmoyDx® Microsatellite Instability (MSI) Detection Kit is a one-step Real-Time PCR technology-based assay specifically designed to assess the MSI status of colorectal cancer (CRC). It tracks variations in microsatellite lengths across eight novel biomarkers (EIF4E3, IFT140, PPP1CC, UBAC2, PRR5-ARHGAP8, ACVR2A, TAOK3, RBM14-RBM4) and presence of MSI indicates a potential defect in the mismatch repair (dMMR) mechanisms.

This kit offers a precise and rapid method to understand the MSI status in CRC, providing valuable insights into the molecular characteristics of the disease.

High Concordance Rate with Fragment Analysis MSI

No need for paired normal tissue samples as control

Streamlined workflow with 10 minutes of hands-on time

99% consistency with gold-standard testing

Fast results within 2 hours

Specifications

Tests/kit 24 (Pre-loaded)
Instrument LighCycler®480 II, cobas z 480, SLAN-96S
Shelf-life 12 months

AmoyDx® PIK3CA Mutation Detection Kit

Technology
PCR

Tumor
Non-small cell lung cancer/ Colorectal cancer

Certificate

 

AmoyDx® PIK3CA Mutation Detection Kit

AmoyDx® PIK3CA Mutation Detection Kit is a real-time PCR assay for in vitro diagnostics (IVD). The kit allows for the qualitative detection of up to 11 somatic mutations in the PIK3CA gene, using human DNA extracted from solid tumor formalin-fixed paraffin-ded (FFPE) tissue samples. It is designed to assist in identifying the PIK3CA mutation status in patients who may qualify for approved targeted therapies. This kit is intended for in vitro diagnostic use and should be operated by trained professionals within a laboratory setting.

High sensitivity of 1%

Fast turnaround time of 1.5 hours

Low sample input requirement

Compatible with mainstream real-time PCR instruments

Specifications

Tests/kit 24 (Bulk)
Instrument Stratagene Mx3000P™, ABI7500, LightCycler480 II, Bio-Rad CFX96, SLAN-96S
Shelf-life 8 months

AmoyDx® PIK3CA Five Mutations Detection Kit

Technology
PCR

Tumor
Non-small cell lung cancer/ Colorectal cancer

Certificate

AmoyDx® PIK3CA Five Mutations Detection Kit

AmoyDx® PIK3CA Five Mutations Detection Kit is a real-time PCR assay. This kit enables the qualitative detection of up to 5 somatic mutations within the PIK3CA gene using human DNA extracted from solid tumor formalin-fixed paraffin-ded (FFPE) tissue samples The kit is for research use only (RUO). Not for use in diagnostic procedures.

High sensitivity of 1%

Fast turnaround time of 1.5 hours

Low sample input requirement

Compatible with mainstream real-time PCR instruments

Specifications

Tests/kit 12/24 (Bulk)
Instrument Stratagene Mx3000P™, ABI7500, LightCycler480 II, Bio-Rad CFX96, SLAN-96S, Rotor-Gene Q/6000 (72 wells)
Shelf-life 8 months

AmoyDx® Human Papillomavirus (HPV) Genotyping Detection Kit

Technology
PCR

Tumor
Endometrial cancer (Uterine cancer)

Certificate

 

AmoyDx® Human Papillomavirus (HPV) Genotyping Detection Kit

AmoyDx® Human Papillomavirus (HPV) Genotyping Detection Kit is a real-time PCR assay. The kit enables qualitative detection of up to 19 high-risk HPV DNA (HPV 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 70, 73, and 82) and 2 low-risk HPV DNA (HPV 6 and 11) in cervical exfoliated cells and urogenital tract secretion.

High sensitivity of 1%

Fast turnaround time of 1.5 hours

Low sample input requirement

Compatible with mainstream real-time PCR instruments

Specifications

Tests/kit 48 (Bulk)
Instrument Stratagene Mx3000P™, ABI 7500, LightCycler480, SLAN-96S, Rotor-Gene Q (72 wells)
Shelf-life 12 months

AmoyDx® JAK2 Mutation Detection Kit

Technology
PCR

Tumor
Acute myeloid leukemia/Chronic myeloid leukemia

Certificate

AmoyDx® JAK2 Mutation Detection Kit

AmoyDx® JAK2 Mutation Detection Kit is a real-time PCR assay. The kit enables qualitative detection of V617F mutation in JAK2 gene in human DNA extracted from blood and/or bone marrow sample. The kit is for research use only (RUO). Not for use in diagnostic procedures.

High sensitivity of 1%

Fast turnaround time of 1.5 hours

Low sample input requirement

Compatible with mainstream real-time PCR instruments

Specifications

Tests/kit 24 (Bulk)
Instrument Stratagene Mx3000P™, ABI 7500, ABI 7900HT, ABI StepOnePlus, LightCycler480 II, Bio-Rad CFX96, Rotor-Gene Q/6000 (72 wells)
Shelf-life 12 months

AmoyDx® TERT/HRAS Mutations Detection Kit

Technology
PCR

Tumor
Thyroid cancer

Certificate

AmoyDx® TERT/HRAS Mutations Detection Kit

AmoyDx® TERT/HRAS Mutations Detection Kit is a real-time PCR assay. The kit enables qualitative detection of 2 TERT mutations and 6 HRAS mutations in human DNA extracted from formalin-fixed paraffin-ded (FFPE) tissue samples. The kit is for research use only. Not for use in diagnostic procedures.

High sensitivity of 1%

Fast turnaround time of 1.5 hours

Low sample input requirement

Compatible with mainstream real-time PCR instruments

Specifications

Tests/kit 24 (Bulk)
Instrument ABI7500, LightCycler480 II, Stratagene Mx3000P™, SLAN-96S
Shelf-life 12 months

AmoyDx® DNA and RNA Extraction Kits

Certificate

 

AmoyDx® FFPE DNA Kit AmoyDx® FFPE DNA Kit is an advanced molecular biology solution designed for efficient DNA extraction from formalin-fixed paraffin-ded tissue specimens. Its unique design aims to address the issues of DNA degradation and damage introduced during the formalin fixation and paraffin ding process, ensuring the extraction of high-quality DNA from these samples. Furthermore, the AmoyDx FFPE DNA Extraction Kit proudly holds the certification of IVDR (In Vitro Diagnostic Regulation), providing a highly reliable solution for clinical applications.
AmoyDx® FFPE RNA Kit The AmoyDx® FFPE RNA Kit is an advanced molecular biology solution designed specifically for the efficient extraction of RNA from formalin-fixed paraffin-ded tissue specimens. Its unique design aims to address the issues of RNA degradation and damage introduced during the formalin fixation and paraffin ding process, ensuring the extraction of high-quality RNA from these samples. Furthermore, the AmoyDx® FFPE RNA Kit has obtained certification under IVDR (In Vitro Diagnostic Regulation), providing a highly reliable solution for clinical applications.
AmoyDx® FFPE DNA/RNA Kit The AmoyDx® FFPE DNA/RNA Kit is an advanced molecular biology solution designed for the efficient extraction of both DNA and RNA from limited formalin-fixed paraffin-ded (FFPE) slides. Its unique design addresses the challenges of DNA and RNA extraction from FFPE samples while significantly improving efficiency and saving precious sample material. Importantly, this kit has also obtained IVDR (In Vitro Diagnostic Regulation) certification, ensuring its compliance with European clinical diagnostic regulations and standards.
AmoyDx® Magnetic FFPE DNA Extraction Kit The AmoyDx® Magnetic FFPE DNA Extraction Kit is an advanced DNA extraction tool based on magnetic bead technology, designed specifically for the efficient extraction of DNA from formalin-fixed paraffin-ded (FFPE) tissue samples. This innovative design combines the advantages of magnetic bead technology, significantly enhancing the efficiency and yield of DNA extraction while ensuring the high quality of DNA recovery. Importantly, this kit has also obtained IVDR (In Vitro Diagnostic Regulation) certification, ensuring its compliance with European clinical diagnostic regulations and standards.

User-Friendly Operation: The kit offers a straightforward extraction procedure suitable for users with varying levels of laboratory experience. Detailed instructions are provided to guide users through the process.
AmoyDx® Blood/Bone Marrow DNA Kit The AmoyDx® Blood/Bone Marrow DNA Kit is an efficient DNA extraction tool designed specifically for extracting DNA from blood and bone marrow samples. This unique tool not only enables the efficient extraction of DNA from these samples but also proudly holds CE-IVDR (In Vitro Diagnostic Regulation) certification, demonstrating its compliance with European in vitro diagnostic regulations and standards. This certification provides a highly reliable DNA extraction solution for clinical applications.
AmoyDx® Circulating DNA Kit The AmoyDx® Circulating DNA Kit is an advanced molecular biology tool designed specifically for the efficient extraction of circulating DNA. This unique tool not only enables the effective extraction of circulating DNA but also proudly holds IVDR (In Vitro Diagnostic Regulation) certification, demonstrating its compliance with European in vitro diagnostic regulations and standards. This certification provides a highly reliable circulating DNA extraction solution for clinical applications.
AmoyDx® Tissue DNA Kit The AmoyDx® Tissue DNA Kit is an efficient DNA extraction kit designed specifically for extracting DNA from tissue samples. This tool not only allows for the efficient extraction of tissue DNA but has also been proudly awarded the IVDR (In Vitro Diagnostic Regulation) certification. This certification validates its compliance with European in vitro diagnostic regulations and standards, making it a highly reliable solution for tissue DNA extraction in clinical applications.
AmoyDx® Tissue RNA Kit The AmoyDx® Tissue RNA Kit is an efficient RNA extraction kit specifically designed for extracting RNA from tissue samples. This tool not only allows for the efficient extraction of tissue RNA but also proudly holds IVDR (In Vitro Diagnostic Regulation) certification. This certification validates its compliance with European in vitro diagnostic regulations and standards, establishing it as a highly reliable solution for tissue RNA extraction in clinical applications.

AmoyDx® EGFR 29 Mutations Detection Kit

Technology
PCR

Tumor
Non-small cell lung cancer

Certificate

 

AmoyDx® EGFR 29 Mutations Detection Kit

The AmoyDx® EGFR 29 Mutations Detection Kit is a real-time PCR assay. This kit enables qualitative detection of up to 29 somatic mutations in exons 18-21 of the EGFR gene in human genomic DNA extracted from formalin-fixed paraffin-ded (FFPE) tumor tissue or circulating DNA extracted from plasma/serum. It is intended to aid in identifying EGFR mutation status for patients with non-small cell lung cancer (NSCLC) who may be eligible for approved targeted therapies. The kit is for in vitro diagnostic use and intended to be used by trained professionals in a laboratory environment.

High sensitivity of 1%

Fast turnaround time of 1.5 hours

Low sample input requirement

Compatible with both FFPE tissue and liquid biopsy samples

Specifications

Tests/kit 10 (Pre-loaded) / 24 (Bulk)
Instrument Stratagene Mx3000P™, ABI 7300, ABI 7500, ABI 7900HT, ABI StepOnePlus, LightCycler480 II, cobas® z480, Bio-Rad CFX96, SLAN-96S
Shelf-life 12 months

Super-ARMS® EGFR Mutation Detection Kit

Technology
PCR

Tumor
Non-small cell lung cancer

Certificate

 

Super-ARMS® EGFR Mutation Detection Kit

The Super-ARMS® EGFR Mutation Detection Kit is a real-time PCR assay. This kit facilitates the qualitative detection of up to 31 somatic mutations in exons 18-21 of the EGFR gene using human circulating DNA extracted from plasma/serum. It is intended to assist in identifying EGFR mutation status in patients with non-small cell lung cancer (NSCLC) who may qualify for approved targeted therapies. The kit is for in vitro diagnostic use and is intended for use by trained professionals in a laboratory setting.

High sensitivity of 0.2%

Fast turnaround time of 1.5 hours

Low sample input requirement

Compatible with liquid biopsy samples

Specifications

Tests/kit 12 (Bulk)
Instrument Stratagene Mx3000P™, ABI 7300, ABI 7500, ABI 7900HT, ABI StepOnePlus, LightCycler480 II, cobas® z480, Bio-Rad CFX96, SLAN-96S
Shelf-life 8 months

AmoyDx® ROS1 Gene Fusions Detection Kit

Technology
PCR

Tumor
Non-small cell lung cancer

Certificate

 

AmoyDx® ROS1 Gene Fusions Detection Kit

The AmoyDx® ROS1 Gene Fusions Detection Kit is a real-time PCR assay. It allows for qualitative detection of up to 14 ROS1 gene fusions in human RNA extracted from formalin-fixed paraffin-ded (FFPE) tumor tissue. This kit is intended to assist in identifying the ROS1 fusion status for patients with non-small cell lung cancer (NSCLC) who may qualify for approved targeted therapies. It is intended for in vitro diagnostic use and should be operated by trained professionals in a laboratory setting.

Fast turnaround time of 1.5 hours

Low sample input requirement

One-step assay with simple operation

High sensitivity of 125-250 cp/rxn

Specifications

Tests/kit 12 (Bulk)
Instrument Stratagene Mx3000P™, ABI 7500, LightCycler480 II, Bio-Rad CFX96, Rotor-Gene Q/6000 (72 wells), SLAN-96S
Shelf-life 12 months

AmoyDx® NTRK Gene Fusions Detection Kit

Technology
PCR

Tumor
Non-small cell lung cancer/ Colorectal cancer

Certificate

 

AmoyDx® NTRK Gene Fusions Detection Kit

AmoyDx® NTRK Gene Fusions Detection Kit is a real-time PCR assay. This kit enables the qualitative detection of up to 109 fusions involving the NTRK1/2/3 genes in human RNA extracted from solid tumor formalin-fixed paraffin-ded (FFPE) tissue samples. It is designed to assist in identifying NTRK fusion status for patients who may benefit from approved targeted therapies. The kit is intended for in vitro diagnostic use and should be operated by trained professionals in a laboratory setting.

High sensitivity of 1%

Fast turnaround time of 1.5 hours

Low sample input requirement

Compatible with mainstream real-time PCR instruments

Specifications

Tests/kit 24 (Bulk)
Instrument Stratagene Mx3000P™, ABI 7500, ABI 7900HT, ABI StepOnePlus, LightCycler480 II, Bio-Rad CFX96, SLAN-96S
Shelf-life 12 months

AmoyDx® BRAF V600 Mutations Detection Kit

Technology
PCR

Tumor
Non-small cell lung cancer/ Colorectal cancer

Certificate

 

AmoyDx® BRAF V600 Mutations Detection Kit

AmoyDx® BRAF V600 Mutations Detection Kit is an in vitro real-time PCR assay. The kit enables qualitative detection of V600 mutations in BRAF gene in human DNA extracted from formalin-fixed paraffin-ded (FFPE) tissue samples.

High sensitivity of 1%

Fast turnaround time of 1.5 hours

Low sample input requirement

Compatible with mainstream real-time PCR instruments

Specifications

Tests/kit 24 (Bulk)
Instrument Stratagene Mx3000P™, ABI 7500, ABI 7900HT, ABI StepOnePlus, LightCycler480 II, Bio-Rad CFX96, SLAN-96S
Shelf-life 12 months

AmoyDx ® OncoPro Liquid NGS Panel

Technology
NGS

Tumor
Pan-tumor/ Non-small cell lung cancer/ Colorectal cancer/ Breast cancer/ Ovarian cancer/ Prostate cancer

Certificate

 

The AmoyDx® OncoPro Liquid NGS Panel is a next-generation sequencing (NGS)-based assay designed for the qualitative detection of single nucleotide variants (SNVs), insertions and deletions (InDels), gene fusions, and copy number variations (CNVs) across 152 target genes, as well as for determining tumor microsatellite instability (MSI) status. The panel detects these genetic alterations using circulating cell-free DNA (cfDNA) extracted from plasma, derived from anticoagulated peripheral whole blood samples.

Specifications

Sample Type Plasma ctDNA
Tests/kit 24 reactions/kit
Target Regions 152 genes plus MSI
Instrument Illumina NextSeq 500/550/550Dx (RUO), NovaSeq 6000

Mutations

SNV/INDELS

  • ABRAXAS1
  • AKT1
  • AKT2
  • AKT3
  • ALK
  • APC
  • AR
  • ARAF
  • ARID1A
  • ATM
  • ATR
  • AURKA
  • B2M
  • BAP1
  • BARD1
  • BCL2L11
  • BRAF
  • BRCA1
  • BRCA2
  • BRIP1
  • CCND1
  • CCND2
  • CCNE1
  • CD274
  • CDH1
  • CDK12
  • CDK4
  • CDK6
  • CDKN2A
  • CDKN2B
  • CHEK1
  • CHEK2
  • CTNNB1
  • CYP2D6
  • DDR2
  • DPYD
  • EGFR
  • EPCAM
  • ERBB2
  • ERBB3
  • ERBB4
  • ERCC1
  • ERCC2
  • ERCC3
  • ERCC4
  • ESR1
  • EZH2
  • FANCA
  • FANCD2
  • FANCL
  • FANCM
  • FBXW7
  • FGF19
  • FGF3
  • FGFR1
  • FGFR2
  • FGFR3
  • FGFR4
  • FH
  • GATA3
  • GEN1
  • GNA11
  • GNAQ
  • GNAS
  • HDAC2
  • HNF1A
  • HRAS
  • IDH1
  • IDH2
  • JAK1
  • JAK2
  • JAK3
  • KDR
  • KEAP1
  • KIT
  • KRAS
  • MAP2K1
  • MAP2K2
  • MAP2K4
  • MAPK1
  • MAPK3
  • MDM2
  • MDM4
  • MET
  • MLH1
  • MPL
  • MRE11
  • MSH2
  • MSH6
  • MTAP
  • MTOR
  • MUTYH
  • MYC
  • MYCN
  • NBN
  • NF1
  • NF2
  • NFE2L2
  • NOTCH1
  • NPM1
  • NRAS
  • NRG1
  • NTRK1
  • NTRK2
  • NTRK3
  • PALB2
  • PDCD1
  • PDGFRA
  • PIK3CA
  • PIK3CB
  • PIK3R1
  • PMS2
  • POLD1
  • POLE
  • PPARG
  • PTCH1
  • PTEN
  • PTPN11
  • RAD50
  • RAD51
  • RAD51B
  • RAD51C
  • RAD51D
  • RAD52
  • RAD54L
  • RAF1
  • RASA1
  • RB1
  • RET
  • RHEB
  • RHOA
  • RICTOR
  • RIT1
  • RNF43
  • ROS1
  • SETD2
  • SF3B1
  • SLX4
  • SMAD4
  • SMARCA4
  • SMO
  • STK11
  • TERT
  • TMPRSS2
  • TP53
  • TSC1
  • TSC2
  • TSHR
  • UGT1A1
  • VHL
  • XRCC1
  • XRCC2

CNV

  • BRCA1
  • BRCA2
  • ERBB2
  • MET
  • PIK3CA
  • PTEN

FUSIONS

  • ALK
  • AR
  • BRAF
  • EGFR
  • ERBB2
  • ERBB4
  • ESR1
  • FGFR1
  • FGFR2
  • FGFR3
  • FGFR4
  • KIT
  • MET
  • NRG1
  • NTRK1
  • NTRK2
  • NTRK3
  • PDGFRA
  • RAF1
  • RET
  • ROS1
  • TERT
  • TMPRSS2

AmoyDx® Super-ARMS ESR1 PCR Kit

Technology
PCR

Tumor
Breast cancer

Certificate

The AmoyDx® Super-ARMS ESR1 PCR Kit is a qualitative real-time PCR assay designed to detect 29 somatic mutations in the ESR1 gene across exons 4, 5, 6, 7, and 8 using circulating free DNA (cfDNA) extracted from plasma samples. cfDNA, derived from apoptotic and necrotic tumor cells, is detectable in the peripheral blood of breast cancer patients. Plasma-based detection of ESR1 mutations provides a non-invasive method for assessing mutation status, particularly in late-stage breast cancer cases, as cfDNA in early-stage patients is often more fragmented and present at lower concentrations.

 

Comprehensive ESR1 Gene Coverage

Covers 29 ESR1 mutations

Limit of detection as low as 0.2%

Cost-efficient

Turnaround time within 5.5 hours

Technology

Super-ARMS® represents an advancement over traditional ARMS technology achieved through enhanced primer and probe design.
With Super-ARMS, efficient amplification occurs when the 3’ base of the primer perfectly matches the mutant template. Conversely, if the 3’ base mismatches with the wild-type template, amplification efficiency is significantly reduced.

The refined primer design significantly enhances both specificity and sensitivity, offering improved performance in mutation detection.

Specifications

Sample Type cfDNA extracted from plasma sample
Tests/kit 14
Instrument QuantStudio5, SLAN-96S

Custom Services

Pharma Service

Expedite and streamline your oncology drug development journey

Contact Us

Comprehensive Solutions for Pharma Service

As a pioneer in companion diagnostics (CDx), AmoyDx highly values our partnerships with pharmaceutical companies, and we are committed to continuously developing innovative diagnostics approaching precision medicine, delivering tailored treatments to maximize clinical benefits.From early development to regulatory approval, we offer comprehensive solutions to accelerate drug development, including drug related biomarker discovery, bespoke assay development, global assay transfer, CTA service, companion diagnostics kits development and post-marketing investigational studies.

Literature

Publications

1. Xiuhuan Ji, Nanying Che, Rixu lin, Jianou Chen, Xiuling Wu. Efficient ten-gene analysis of NSCLC tissue samples by next-generation sequencing. Pathology - Research and Practice, Volume 215, Issue 5, 2019, Pages 1066-1070.
2. Xu H, Baidoo AA, Su S, Ye J, Chen C, Xie Y, Bertolaccini L, Ismail M, Ricciuti B, Ng CS, Flores RM, Li Y; written on behalf of AME Lung Cancer Collaborative Group. A comparison of EGFR mutation status in tissue and plasma cell-free DNA detected by ADx-ARMS in advanced lung adenocarcinoma patients. Transl Lung Cancer Res 2019;8(2):135-143.
3. Wu, W., Cao, Z., Zhang, W. et al. Comparison of the SuperARMS and ARMS for detecting EGFR mutations in liquid-based cytology specimens from NSCLC patients. Diagn Pathol 15, 9 (2020).
4. Wu, W., Huang, Y., Guo, J., Xie, X., Li, H., Cao, Z., Wei, H. and Wu, C. (2020), Detection and comparison of EGFR mutations from supernatants that contain cell-free DNA and cell pellets from FNA non–small cell lung cancer specimens. Cancer Cytopathology, 128: 545-552.
5. Ma Y, Li Q, Du Y, Chen W, Zhao G, Liu X, Li H, Liu J, Shen Z, Ma L, Zhou Y. Oncogenic Genetic Alterations in Non-Small-Cell Lung Cancer (NSCLC) in Southwestern China. Cancer Manag Res. 2020;12:10861-10874.
6. Zhang, R., Gao, P., Han, Y. et al. Reliable assessment of BRCA1 and BRCA2 germline variants by next-generation sequencing: a multicenter study. Breast Cancer 28, 672–683 (2021).
7. Xingran Jiang, Xiumei Hu, Yajuan Gu, Yunlong Li, Mulan Jin, Hongying Zhao, Ruixia Gao, Zhan Huang, Jun Lu. Homologous recombination repair gene mutations in Chinese localized and locally advanced prostate cancer patients. Pathology - Research and Practice, Volume 224, 2021, 153507.
8. Liu H, Zhang Z, Chen L, Pang J, Wu H and Liang Z (2022) Next-Generation Sequencing Reveals a Very Low Prevalence of Deleterious Mutations of Homologous Recombination Repair Genes and Homologous Recombination Deficiency in Ovarian Clear Cell Carcinoma. Front. Oncol. 11:798173.
9. Scheiter A, Hierl F, Winkel I, Keil F, Klier-Richter M, Coulouarn C, Lüke F, Kandulski A, Evert M, Dietmaier W, et al. Wnt/β-Catenin-Pathway Alterations and Homologous Recombination Deficiency in Cholangiocarcinoma Cell Lines and Clinical Samples: Towards Specific Vulnerabilities. Journal of Personalized Medicine. 2022; 12(8):1270.
10. Fumagalli, C., Betella, I., Ranghiero, A., Guerini-Rocco, E., Bonaldo, G., Rappa, A., Vacirca, D., Colombo, N. and Barberis, M. 2022. In-house testing for homologous recombination repair deficiency (HRD) testing in ovarian carcinoma: a feasibility study comparing AmoyDx HRD Focus panel with Myriad myChoiceCDx assay. Pathologica - Journal of the Italian Society of Anatomic Pathology and Diagnostic Cytopathology. 114, 4 (Sep. 2022), 288-294.
11. Ou, Sai-Hong Ignatius et al. Efficacy of Brigatinib in Patients With Advanced ALK-Positive NSCLC Who Progressed on Alectinib or Ceritinib: ALK in Lung Cancer Trial of brigAtinib-2 (ALTA-2). Journal of Thoracic Oncology, Volume 17, Issue 12, 1404 - 1414.
12. Takamori S, Seto T, Yamaguchi M, Kinoshita F, Fujishita T, Ito K, Toyozawa R, Shoji F and Okamoto T (2022) Case report: Success of tepotinib therapy in overcoming resistance to osimertinib in a patient with EGFR-mutant lung adenocarcinoma with a potential acquired MET exon 14 skipping mutation. Front. Oncol. 12:965741.
13. Dong, Z., Wang, Y., Zhang, J. et al. Analyzing the effects of BRCA1/2 variants on mRNA splicing by minigene assay. J Hum Genet 68, 65–71 (2023).
14. Doig, Kenneth D. et al. Homologous Recombination Repair Deficiency: An Overview for Pathologists. Modern Pathology, Volume 36, Issue 3, 100049
15. Yuan W, Ni J, Wen H, Shi W, Chen X, Huang H, et al. Genomic Scar Score: A robust model predicting homologous recombination deficiency based on genomic instability. BJOG. 2022; 129(Suppl. 2): 14–22.
16. Magliacane, G.; Brunetto, E.; Calzavara, S.; Bergamini, A.; Pipitone, G.B.; Marra, G.; Redegalli, M.; Grassini, G.; Rabaiotti, E.; Taccagni, G.; et al. Locally Performed HRD Testing for Ovarian Cancer? Yes, We Can! Cancers 2023, 15, 43.
17. Cai, Y., Liu, H., Chen, X., Yang, J., & Huang, B. (2023). P40 and TTF‑1 double‑expressing non‑small cell lung cancer with EML4‑ALK and PIK3CA gene mutations: A case report and review of the literature. Oncology Letters, 25, 59.
18. Qiu, D., Xi, H., Wang, M. et al. The debatable role of immune checkpoint blockade therapy in lung adenocarcinoma-oriented liver metastatic malignant lesions. J Cancer Res Clin Oncol 149, 5791–5802 (2023).
19. Li S, Hou L, Huang Y, et alPrimary salivary duct carcinoma of the lung: clinicopathological features, diagnosis and practical challengesJournal of Clinical Pathology Published Online First: 25 January 2023.
20. Ren, W.; Zhu, Y.; Wang, Q.; Jin, H.; Guo, Y.; Lin, D. Deep Learning-Based Classification and Targeted Gene Alteration Prediction from Pleural Effusion Cell Block Whole-Slide Images. Cancers 2023, 15, 752.
21. Liu Y, Jin B, Shen C, Gao X, Qi X, Ma M, Li H, Hao H, Tang Q, Yang K, Mi Y, Guan J, Feng X, He Z, Li H and Yu W (2023) Somatic and germline aberrations in homologous recombination repair genes in Chinese prostate cancer patients. Front. Oncol. 13:1086517.
22. Kekeeva, T.; Andreeva, Y.; Tanas, A.; Kalinkin, A.; Khokhlova, S.; Tikhomirova, T.; Tyulyandina, A.; Popov, A.; Kuzmenko, M.; Volkonsky, M.; et al. HRD Testing of Ovarian Cancer in Routine Practice: What Are We Dealing With? Int. J. Mol. Sci. 2023, 24, 10497.
23. Feng, Cong et al. Relationship between homologous recombination deficiency and clinical features of breast cancer based on genomic scar score. The Breast, Volume 69, 392 - 400.
24. Lu, S., Pan, H., Wu, L. et al. Efficacy, safety and pharmacokinetics of Unecritinib (TQ-B3101) for patients with ROS1 positive advanced non-small cell lung cancer: a Phase I/II Trial. Sig Transduct Target Ther 8, 249 (2023).
25. Chi, K.N. et al. Niraparib plus abiraterone acetate with prednisone in patients with metastatic castration-resistant prostate cancer and homologous recombination repair gene alterations: second interim analysis of the randomized phase III MAGNITUDE trial. Annals of Oncology, Volume 34, Issue 9, 772 - 782.
26. Minghao Wang, Hongtao Xu, Qiang Han & Liang Wang (2023) Significance of YAP1–MAML2 rearrangement and GTF2I mutation in the diagnosis and differential diagnosis of metaplastic thymoma, Annals of Medicine, 55:2.
27. Atsushi OHTSU, Koichi GOTO, Takayuki YOSHINO. Improvement of patient care using cancer genomic profiling: SCRUM-/CIRCULATE-Japan experience. Proceedings of the Japan Academy, Series B, 2023, Volume 99, Issue 8, Pages 241-253.
28. Yang, James Chih-Hsin et al. Brigatinib Versus Alectinib in ALK-Positive NSCLC After Disease Progression on Crizotinib: Results of Phase 3 ALTA-3 Trial. Journal of Thoracic Oncology, Volume 18, Issue 12, 1743 - 1755.
29. Fountzilas, E.; Papadopoulou, K.; Chatzikonstantinou, T.; Karakatsoulis, G.; Constantoulakis, P.; Tsantikidi, A.; Tsaousis, G.; Karageorgopoulou, S.; Koumarianou, A.; Mauri, D.; et al. Concordance between Three Homologous Recombination Deficiency (HRD) Assays in Patients with High-Grade Epithelial Ovarian Cancer. Cancers 2023, 15, 5525.
30. Kunimasa, K., Matsumoto, S., Honma, K. et al. Utility of needle biopsy in centrally located lung cancer for genome analysis: a retrospective cohort study. BMC Pulm Med 23, 484 (2023). Fountzilas, E.; Papadopoulou, K.; Chatzikonstantinou, T.; Karakatsoulis, G.; Constantoulakis, P.; Tsantikidi, A.; Tsaousis, G.; Karageorgopoulou, S.; Koumarianou, A.; Mauri, D.; et al. Concordance between Three Homologous Recombination Deficiency (HRD) Assays in Patients with High-Grade Epithelial Ovarian Cancer. Cancers 2023, 15, 5525.
31. Jiang, T., Chen, J., Xu, X. et al. On-treatment blood TMB as predictors for camrelizumab plus chemotherapy in advanced lung squamous cell carcinoma: biomarker analysis of a phase III trial. Mol Cancer 21, 4 (2022).
32. Ren, Shengxiang et al. Camrelizumab Plus Carboplatin and Paclitaxel as First-Line Treatment for Advanced Squamous NSCLC (CameL-Sq): A Phase 3 Trial. Journal of Thoracic Oncology, Volume 17, Issue 4, 544 - 557.
33. Xu, Y., Huang, Z., Fang, J., Liu, A., Lu, H., Yu, X., Chen, K., Xu, X., Ma, X., Shi, W., Kim, Y., Hakozaki, T., Addeo, A., Shen, Y., Li, S., & Fan, Y. (2022). Tolerability, safety, and preliminary antitumor activity of fuzuloparib in combination with SHR-1316 in patients with relapsed small cell lung cancer: a multicenter, open-label, two-stage, phase Ib trial. Translational Lung Cancer Research, 11(6), 1069-1078.
34. Liu, X., Zhang, X., Liu, C. et al. Immune and inflammation: related factor alterations as biomarkers for predicting prognosis and responsiveness to PD-1 monoclonal antibodies in cervical cancer. Discov Onc 13, 96 (2022).
35. Wang, Lei-Chi et al. Panoramic Tissue Examination That Integrates 3-Dimensional Pathology Imaging and Gene Mutation: Potential Utility in Non–Small Cell Lung Cancer. Laboratory Investigation, Volume 103, Issue 9, 100195.
36. Gu Y, Zhang S, Liang X, Zhao H, Li X, Lu J. Clinical and Pathological Characteristics and Prognosis of Lung Adenocarcinoma With High-Grade Fetal Features: A Retrospective Analysis. International Journal of Surgical Pathology. 2023;0(0).
37. Pecciarini L, Brunetto E, Grassini G, De Pascali V, Ogliari FR, Talarico A, Marra G, Magliacane G, Redegalli M, Arrigoni G, et al. Gene Fusion Detection in NSCLC Routine Clinical Practice: Targeted-NGS or FISH? Cells. 2023; 12(8):1135.
38. Okimura A, Hirano H, Ito Y, et al. (September 11, 2023) Primary Lung Adenocarcinoma With ALK Gene Rearrangement Mostly Occupied by the Signet-Ring Cell Carcinoma Component: A Case Report. Cureus 15(9): e45068.
39. Ishioka Y, Tanaka H, Makiguchi T, Fujishima S, Nunomura Y, Sakamoto H, Shiratori T, Taima K and Tasaka S: Predictors of efficacy of anamorelin in patients with non‑small cell lung cancer and cachexia: A retrospective study. Oncol Lett 27: 22, 2024
40. Sakamoto T, Matsubara T, Takahama T, et al. Biomarker Testing in Patients With Unresectable Advanced or Recurrent Non–Small Cell Lung Cancer. JAMA Netw Open. 2023;6(12):e2347700.
41. Takeyasu Y, Yoshida T, Masuda K, et al. Distinct progression and efficacy of first-line osimertinib treatment according to mutation subtypes in metastatic NSCLC harboring EGFR mutations. JTO Clin Res Rep. 2024;5:100636.
42. Hirotsu, Y., Nakagomi, T., Nagakubo, Y. et al. Simulation analysis of EGFR mutation detection: Oncomine Dx target test and AmoyDx panel impact on lung cancer treatment decisions. Sci Rep 14, 1594 (2024).