Oncology line: kits for PCR and qPCR

Amoy Diagnostics Co., Ltd. (AmoyDx) a leading company in precision oncology medicine. With numerous patents covering their intellectual property for Adx-ARMS and Super-ARMS technologies. These technologies enable highly sensitive detection on par with digitalPCR and NGS.
AmoyDx has a comprehensive portfolio of molecular diagnostic tests including, but not limited to, EGFR, RAS, ALK, BRAF, PIK3CA, and ROS1 test kits, which are CE-certified and will soon follow the new IVDR standard.

"An emerging approach of disease treatment and prevention that takes into account each person's individual variabilitỳ of genes, environment and lifestyle." It is a continuously developing field, ranging from cancer, to personalized therapies in all areas of health and disease."

The multi-gene approach in daily clinical practice is recommended for the following diseases: non-small cell lung cancer (NSCLC), prostate cancer, ovarian cancer, and cholangiocarcinoma.

- AmoyDx line for Real Time PCR detection of major cancer-associated mutations
- Testing available for different platforms: SLAN-96, Stratagene Mx3000, CFX96, QuantumStudio5, ABI7500, Rotorgene (72 well), LightCycler480
- Availability of single or multiplexed targets for different sample and thermal cycler types
- Pre-loaded format in strips for reduced handedness or in bulk
- Results within 90 minutes

Products

01

Lung Cancer

Amoy

Numerous oncogenic alterations have been identified as critical in lung cancer pathogenesis and choice of therapy. Oncogenes include EGFR, ALK, ROS1, BRAF, MET, HER2, RET, NTRK, KRAS.
In non-small-cell lung cancer (NSCLC), multi-target testing is crucial for targeted therapy and efficient identification of potentially effective drugs.

Pan Lung Cancer PCR Panel - 11 GENI DRIVER

167 variants on 11 genes
Diagnostic completeness, rapidity of execution, cost-effectiveness typical of PCR, RNA and DNA simultaneously, high sensitivity
11 driver genes. EGFR/KRAS/BRAF/HER2/ALK/ROS1/RET/MET/
NTRK17NTRK2/NTRK3
This test allows even samples not suitable for NGS to be answered.

AmoyDx® Pan Lung Cancer PCR Panel (Qs)

No. 8.0131202W008J 8 tests No. 8.0131202W008B 8 tests

Multi-Gene Mutations Detection Kit - 9 GENI DRIVER

Detection of hotspot mutations/fusions in 9 EGFR/ KRAS/ BRAF/ NRAS/ HER2/ PIK3CA/ ALK/ ROS1/RET driver genes in a single assay from a single tissue sample.

The kit detects 118 mutations.

Multi-Gene Mutations Detection Kit

No. 8.01.26301W006A 8.01.26301W006B 8.01.26301W006D *SLAN only 8.01.26301W006J 6 tests

Super-ARMS® EGFR Mutations Detection Kit

Evaluation of EGFR mutation status.
The kit adopts the innovative Super-ARMS® technology. Its optimized reaction system can quickly and accurately detect a low percentage of mutant ctDNA.

The kit detects 42 EGFR mutations.

Super-ARMS® EGFR Mutation Detection Kit

No. 8.01.20213X012E 12 tests

Super-ARMS® EGFR T790M Mutations Detection Kit

The kit selectively detects the T790M mutation.
( c.2369C>T) in exon 20.

Super-ARMS® EGFR T790M Mutation Detection Kit

No.8.01.20212X024D 24 tests

EGFR29 Mutations Detection Kit

The kit detects 29 EGFR mutations, including activation and resistance mutations.

AmoyDx® EGFR 29 Mutations Detection Kit

Cod 8.01.20201W010A 8.01.20201W010B 8.01.20201W010D*SLAN only 8.01.20201X024E 8.01.20201X024F 10-24 test

ALK-ROS1 Gene Fusion Detection Kit

The kit detects 26 ALK gene fusions and 14 ROS1 gene fusions.

AmoyDx® ALK Gene Fusions and ROS1 Gene Fusions Detection Kit


No. 8.01.24401W008A 8.01.24401W008B 8.01.24401W008D*SLAN only 8 tests

ELM4-ALK Fusion Gene Detection Kit

EML4-ALK is a chimeric gene.
The kit detects 21 most common fusion transcripts.

AmoyDx® EML4-ALK Fusion Gene Detection Kit

No. 8.01.22001X024H 24 tests

ROS1 Gene Fusion Detection Kit

ROS 1 is a receptor tyrosine kinase of the insulin receptor family.
The kit detects 14 ROS1 fusion genes.

AmoyDx® ROS1 Gene Fusions Detection Kit

No. 8.01.23201X012A 8.01.23201X012B 8.01.23201X012D*SLAN only 8.01.23201X012H 12 tests

RET Gene Fusion Detection Kit

The RET gene is a proto-oncogene that acts as a receptor for a number of GDNF family proteins.
The kit detects 9 fusion genes.

AmoyDx® RET Gene Fusions Detection Kit

No. 8.01.23301X012H 12 tests

EGFR/ALK/ROS1 Mutations Detection Kit

The kit simultaneously detects 24 EGFR mutations (exons 18-21), 21 ALK gene fusions and 13 ROS1 gene fusions.

No. 8.01.25501W008A 8.01.25501W008D*SLAN only 8.01.25501W008J 12 tests

MET Skipping Gene Mutation Detection Kit

Skipping leads to deletion of the iuxtamembrane domain of MET.
The kit detects skipping of exon 14 in the MET gene.

AmoyDx® MET Mutation Detection Kit

No. 8.01.26101X024H 24 tests

NTRK Gene Fusion Detection Kit

NTRK (Neurotrophic tropomyosin-related kinase) is the name of a family of three genes (NTRK1, 2 and 3) that code for tropomyosin receptor kinases (TRK) A, B and C.
The kit detects 109 fusions in the NTRK1, NTRK2, NTRK3 genes.

AmoyDx® NTRK Gene Fusions Detection Kit

No. 8.0126001X024E 24 tests

HER2 Mutation Detection Kit

The most common mutation is an in-frame insertion in exon 20.
The kit detects 13 mutations in the HER2 gene.

AmoyDx® HER2 Mutation Detection Kit

No. 8.01.26801X012H 12 tests

02

Colorectal Cancer

Amoy

Certain somatic mutations involving genes such as KRAS, NRAS, BRAF, and PIK3CA have been recognized as having prognostic and predictive value for specific colorectal cancer therapies.
In total, KRAS, NRAS, and PIK3CA somatic mutations occur in 20-50%, 1-6%, 10-30% respectively. The most common BRAF mutations are V600 mutations in exon 15, which occur in 8-15%.
Patients without RAS mutations (in exon 2,3,4) may benefit from the drugs Erbitux (cetuximab) or Vectibix (panitumumab). BRAF and PIK3CA mutations have a high probability of being nonresponsive to cetuximab or panitumumab. Patients with metastatic colorectal cancer should always be genotyped for RAS (KRAS, NRAS) and BRAF.

NRAS Gene Mutation Detection Kit

NRAS is a member of the RAS family of small GTPases and plays a central role in MAPK signaling pathways.
The kit detects 16 mutations in NRAS codons 12, 13, 59, 61, 117 and 146.

AmoyDx® NRAS Mutation Detection Kit

Code.
8.01.25001W008A
8.01.25001X024H

8-24 test

KRAS Gene Mutation Detection Kit

The KRAS protein is a small GTPase and one of the key molecules in the downstream signaling pathway of the epidermal growth factor receptor (EGFR).
The kit detects 19 mutations in KRAS codons 12, 13, 59, 61, 117 and 146.

AmoyDx® KRAS Mutation Detection Kit

Code.
8.01.20102W006A
8.01.20102W006B
8.01.20102W006D*SLAN only
8.01.20102X024H

6-24 test

KRAS/NRAS Gene Mutation Detection Kit

The RAS protein is a GTPase and one of the key molecules in the downstream signaling pathway of the epidermal growth factor receptor (EGFR ).
The kit detects 19 KRAS mutations (exons 2, 3 and 4) and 13 NRAS mutations (exons 2, 3 and 4).

AmoyDx® KRAS/NRAS Mutations Detection Kit

Code.
8.01.25402W006A
8.01.25402W006D*SLAN only
8.01.25402X024H

6-24 test

BRAF V600 Gene Mutations Detection Kit

BRAF is a serine/threonine kinase that functions within the Ras-Raf-MEK-MAPK pathway.
The kit detects 6 V600 mutations (1799T>A) in the BRAF oncogene.

AmoyDx® BRAF V600 Mutations Detection Kit

Code 8.01.20302X024E

24 tests

BRAF Gene Mutations Detection Kit

BRAF is a serine/threonine kinase that functions within the Ras-Raf-MEK-MAPK pathway.
The kit detects 6 V600 mutations (1799T>A) in the BRAF oncogene.

AmoyDx® BRAF V600 Mutations Detection Kit

Code 8.01.20302X024E
8.01.20302X024F

24 tests

KRAS/NRAS/BRAF Gene Mutations Detection Kit

The KRAS, NRAS and BRAF genes are the key molecules in the downstream signaling pathway of the epidermal growth factor receptor (EGFR).
The kit detects 17 KRAS mutations (exons 2, 3 and 4), 13 NRAS mutations (exons 2, 3 and 4) and 1 BRAF V600 mutation (exon 15).

AmoyDx® KRAS/NRAS/BRAF Mutations Detection Kit

Code.
8.01.25403W006A
8.01.25403W006B
8.01.25403W006D*SLAN only

6 tests

Super-ARMS® KRAS/NRAS/BRAF Gene Mutation Detection Kit

The KRAS, NRAS and BRAF genes are the key molecules in the downstream signaling pathway of the epidermal growth factor receptor (EGFR).
The kit adopts the innovative Super-ARMS® technology and detects 18 KRAS mutations (exons 2, 3 and 4), 15 NRAS mutations (exons 2, 3 and 4) and 6 BRAF V600 mutations (exon 15).

AmoyDx® KRAS/NRAS/BRAF Mutations Detection Kit

6 tests

PIK3CA Gene Mutations Detection Kit

The kit detects 5 mutations in the alpha catalytic subunit of phosphoinositide-3-kinase (PIK3CA).

AmoyDx® PIK3CA 5Mutations Detection Kit

Code.
8.01.21601X024E
8.01.21601X012F

PIK3CA 11 Gene Mutations Detection Kit

The kit detects 11 mutations in the alpha catalytic subunit of phosphoinositide-3-kinase (PIK3CA).

AmoyDx® PIK3CA 11 Mutations Detection Kit

Code.
8.01.26001X024E

TERT/HRAS Gene Mutations Detection Kit

Detection of two TERT promoter mutations and six somatic HRAS mutations.

AmoyDx® TERT/HRAS Mutations Detection Kit

Code.
8.01.27701X024B
8.01.27701X024D*SLAN only

03

Cervical Cancer

Amoy

Human papillomavirus (HPV) is a sexually transmitted DNA virus that establishes infection in the squamous epithelial cells of the human body. There are more than 200 types of HPV, which can be classified into high- or low-risk types depending on their oncogenic potential. Determination of high-risk HPVs also called oncogenic HPVs, which have been shown to cause cancer, such as HPV16 and 18. And some HPVs are potentially carcinogenic to humans, such as HPV26, 53, 66, 70, 73 and 82, which are classified as high-risk or probably high-risk HPVs. Low-risk HPVs can cause genital warts and low-grade changes in cells, but rarely cause cancer, such as HPV6 and 11.

High-risk Human Papillomavirus (HPV) Detection Kit

Screening kits for 19 high-risk HPV (16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 70, 73 and 82).

AmoyDx® High-risk Human Papillomavirus (HPV) Detection Kit

No. 8.01.25802X048E
48 tests

Human Papillomavirus (HPV) Genotyping Detection Kit

Genotyping kits for 21 HPVs of which 19 are high-risk:
High risk 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 70, 73, and 82.
low risk 6 and 11.

AmoyDx® Human Papillomavirus (HPV) Genotyping Detection Kit

No. 8.01.25803X048E
48 tests

04

Dedicated manual extraction

Amoy

FFPE DNA

FFPE DNA

8.02.23501X036G

FFPE RNA

FFPE RNA

8.02.24101X036G

FFPE DNA/RNA

FFPE DNA/RNA

8.02.23601X036G

Circulating DNA

Circulating DNA

8.02.26201X024G

Blood DNA

Blood DNA

8.02.24201X036G

Tissue DNA

Tissue DNA

8.02.24301X036G

Tissue RNA

Tissue RNA

8.02.24601X036G

Cell-free DNA Tube

Cell-free DNA Tube

8.02.26401X010G

Brand in evidence