Amoy Diagnostics Co., Ltd. of Xiamen at MEDICA 2017 in Düsseldorf -- MEDICA Trade Fair
Manufacturers

Amoy Diagnostics Co., Ltd.

39 Dingshan Road, Haicang District, 361027 Xiamen
China, People’s Republic

Telephone +86 592 6806835
Fax +86 592 6806839
sales@amoydx.com, zhangyan@amoydx.com

This company is co-exhibitor of
P&L Scientific Inc.

Hall map

MEDICA 2017 hall map (Hall 3): stand F41

Fairground map

MEDICA 2017 fairground map: Hall 3

Our range of products

Product categories

  • 03  Diagnostics
  • 03.01  Clinical chemistry
  • 03.01.07  Gene tests / molecular biological diagnostic

Our products

Product category: Gene tests / molecular biological diagnostic

Super-ARMS EGFR Mutation Detection Kit

Super-ARMS EGFR Mutation Detection Kit
Currently there are several EGFR-TKIs approved for NSCLC (Non-small Cell Lung Cancer) targeted therapy including first-generation TKIs (gefitinib and erlotinib), second-generation TKI (afatinib) and third-generation TKI (osimertinib). To select right patients for these therapies, it is essential to detect EGFR mutation status before the treatment decision.

NSCLC tissue testing has been applied to EGFR mutation detection for years. However, up to 25% of patients with advanced or metastatic NSCLC do not have an available or sufficient tumor tissue sample for this method of testing. More and more dynamic monitoring demand for EGFR mutation status appears. When tissue sample is not a reliable or realistic option, the ctDNA (circulating tumor DNA) obtained from blood sample can be used for the assessment of EGFR mutation status.

Supe-rARMS® EGFR kit is a highly sensitive, real-time PCR-based test which is designed to identify ctDNA EGFR mutation in plasma samples for patients with advanced or metastatic NSCLC. The kit adopts innovative ADx-Super-ARMS® technology which is upgraded from ADx-ARMS technology. Its optimized reaction system can rapidly and accurately detect low percentage of mutant ctDNA in a background of wild-type DNA.

Intended Use:
For research purpose use only.

Technological Principles:
The Super-ARMS® EGFR mutation kit enables detection of the following 41 EGFR mutations:

  • Exon 18: G719C, G719A
  • Exon 19: 29 deletions
  • Exon 20: T790M, S768I, 6 insertions
  • Exon 21: L858R, L861Q

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Product category: Gene tests / molecular biological diagnostic

HER-2 Gene Amplification Analysis Kit inquiry_ico

HER-2 Gene Amplification Analysis Kit
FISH assay for detection of HER-2 gene amplification and over-expression

The proto-oncogeneHER-2 gene (also called ERBB2 or HER2/neu) is a member of the human epidermal growth factor receptor (HER/EGFR/ERBB) family, which is locatedat the long arm of human chromosome 17 (17q12-q21).HER-2 geneencodes a 185-kDa HER-2 protein, which is a membrane receptor tyrosinekinase with homology to EGFR(HER-1).

Amplification or over-expression of HER-2 gene has been shown to play an important role in the development and progression of several aggressive types of human cancers, which occurs in 20-30% of breast cancer, approx. 20% of gastric cancer, also prostate, ovarian cancer and uterine serous endometrial carcinoma.

Demonstration of HER-2 gene amplification or over-expression is essential for initiating therapy with HER-2 targeted therapy, such as Herceptin™, a monoclonal antibody to HER-2 protein. Clinical studies have shown that patients whose tumors have high HER-2 gene amplification or over-expression benefit most from Herceptin™.

Intended Use:
The kit is a qualitative test to accurately identify HER-2 gene amplification and over-expression via fluorescence in situhybridization (FISH) technology. The used specimen is formalin-fixed paraffin-embedded (FFPE) tissue of breast and gastric cancers.

Technological Principles:
The kit usesfluorescence in situhybridization (FISH) technology, which employs a dual-colorHER-2/CSP17 FISH probe with two fluorescent-labeled DNA probes to detect HER-2 gene amplification and over-expression.The tissue specimens were handled with a series of pre-treatment procedures, and the targeted DNA is denatured to single-stranded form and hybridized with the FISH probes. Following a series of wash and counterstain steps, the hybridization of the probes is viewed using a fluorescence microscope equipped with appropriate excitation and emission filters, then the HER-2/CSP17 ratio is calculated.

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Product category: Gene tests / molecular biological diagnostic

HPV 6/11/16/18 Detection Ki

HPV 6/11/16/18 Detection Kit
Real-Time PCR Assay for Detection of 2 High-risk HPVs and 2 low-risk HPVs

Human papillomavirus (HPV) is a sexually transmitted DNA virus that establishes infection in squamous epithelialcells in the human body. There are more than 200 types of HPV, which can be classified into high or low-risktypes depending upon their oncogenic potentials.High-risk HPVs also called oncogenic HPVs, which have been confirmed to cause cancer. Low-risk HPVs can cause genital warts and low-grade changes in thecells, but rarely cause cancer.

The most common HPV types that infect the human body are HPV types 6, 11, 16 and 18. HPV6 and HPV11 are most commonly associated with benign lesions such as genital warts and mild dysplasia of the cervix. HPV16 and HPV18 are known to cause around 70% of cervical cancer cases. Currently there is HPV quadrivalent vaccine that could protect against HPV types 6, 11, 16 and 18, and is recommended primarily for those women not yet having been exposed to HPV.

Intended Use:
The kit is intended for qualitative detection of two high-risk HPV types 16/18 and two low-risk HPV types 6/11.

Technological Principles:
The kit is designed for a specific amplification of L1 gene in HPV DNA. The targeted region of HPV DNA is amplified by several specific primers and detected by novel fluorescence probes. A non-rivalry internal control is added in the HPV DNA detection system to reveal the presence of PCR inhibitors and monitor the accuracy of experimental operation.

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Product category: Gene tests / molecular biological diagnostic

Human Papillomavirus (HPV) Genotyping Detection Kit

Human Papillomavirus (HPV) Genotyping Detection Kit
Real-Time PCR Assay for Genotyping of 19 High-risk HPVs and 2 low-risk HPVs

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

High-risk HPV infection is a necessary for the development of cancers of theuterine cervix, which has been firmly established. Approximately 99.7% of cervical cancers are caused by high-risk HPV infection. In particular, HPV16 and HPV18 are known to cause around 70% of cervical cancer cases.

Intended Use:
The kit is intended for qualitative detection and genotyping of 21 HPV types.
19 high-risk HPV types:
HPV16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 70, 73, and 82.
2 low-risk HPV types:
HPV6 and 11.
The used HPV DNA is extracted from cervical exfoliated cells and urogenital tract secretion.

Technological Principles:
The kit is designed for a specific amplification of L1 gene in HPV DNA. The targeted region of HPV DNA is amplified by several specific primers and detected by novel fluorescence probes. A non-rivalry internal control is added in the HPV DNA detection system to reveal the presence of PCR inhibitors and monitor the accuracy of experimental operation.

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Product category: Gene tests / molecular biological diagnostic

MEK1 Mutation Detection Kit

MEK1 Mutation Detection Kit
Qualitative detection of Detection of three mutations in MEK1 gene

MEK1 (also known as MAP2K1) is a serine-threonine protein kinase,which is a central mediator in the MAP kinase signaling pathway.Somatic mutations in MEK1 (MAP2K1) have been found in approximately 1% of all NSCLC and are more common in adenocarcinoma than squamous cell carcinoma. The most frequently observed mutations are K57N (64%) and Q56P (19%), and MEK1 mutations were mutually exclusive with mutations in EGFR, KRAS, BRAF and other driver mutations.

References:
  1. Arcila ME, et al., MAP2K1 (MEK1) Mutations Define a Distinct Subset of Lung Adenocarcinoma Associated with Smoking. ClinCancer Res. 2014
  2. Marks JL, et al., Novel MEK1 mutation identified by mutational analysis of epidermal growth factor receptor signaling pathway genes in lung adenocarcinoma. Cancer Res. 2008

Intended Use
The AmoyDx®MEK1 Mutation Detection Kit is an in vitro nucleic acid amplification test intended for qualitative detection ofthree MEK1gene mutations in human NSCLC tissue, formalin-fixed paraffin-embedded (FFPE) tissue specimens.
This kit is intended for research use only.


Technological Principles
The kit uses novel, proprietary primers and probes in a real-time PCR assay to detect three MEK1mutations in human genomic DNA. The mutant DNA is amplified by the specific primers, and detected by the novel probes.

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About us

Company details

Amoy Diagnostics Co., Ltd. (AmoyDx) focuses on molecular diagnostics for oncology precision medicine. With completely independent intellectual property rights of ADx-ARMS and Super-ARMS technologies, AmoyDx has a market-leading portfolio of molecular diagnostic kits including but not limited to EGFR, RAS, ALK, BRAF, PIK3CA and ROS1 testing kits, which were firstly approved by CFDA and CE certified. In European EMQN and Chinese PQCC quality control programs, AmoyDx is the NO.1 testing kit supplier for some years and always achieves the highest accuracy rate. Nowadays AmoyDx serves an extensive domestic and international oncology network reaching over 300 hospitals in China and 50 countries all over the world. Every year hundreds of thousands of cancer patients benefit from AmoyDx products. AmoyDx is strategic diagn...

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