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Visit AmoyDx at the 19th World Conference on Lung Cancer (WCLC) 2018 in Canada
Amoy Diagnostics will be exhibiting at 19th World Conference on Lung Cancer 2018 of IASLC in Toronto, Canada. Welcome to visit us at booth 206.
News & Events
Amoy Diagnostics achieved China NMPA Approval of Multi-Genes Mutations Detection Kit
Amoy Diagnostics Co., Ltd. (AmoyDx, SHE:300685) announced that NMPA(National Medical Products Administration)approved its Multi-Genes Mutations Detection Kit on Aug 24, 2018.
News & Events
Meet AmoyDx at ELCC 2018 in Switzerland for NSCLC Molecular Testing
Amoy Diagnostics will be exhibiting at the ELCC 2018 in Geneva, Switzerland. Welcome to visit us.  The exhibition details are below.
News & Events
China NMPA grants approval to AmoyDx Super-ARMS EGFR mutation test kit
(January 22, 2018, Xiamen China)  Amoy Diagnostics Co., Ltd. (AmoyDx, SZ:300685)  announced that NMPA(National Medical Products Administration)approved AmoyDx Super-ARMS® EGFR mutation test kit
News & Events
AmoyDx Distributors Annual Meeting (APAC-MEAF) 2017
AmoyDx Distributors Annual Meeting (APAC-MEAF) 2017 was held in Xiamen, China on December 4. Distributors from different countries gathered to get the recent update on precision oncology
News & Events
AmoyDx Distributors Annual Meeting (Europe) 2017
AmoyDx Distributors Annual Meeting (Europe) 2017 was held in Dusseldorf, Germany on November 15. Distributors from different European countries gathered to get the recent update on precision oncology
News & Events
Visit AmoyDx at MEDICA 2017, Germany
As the world’s largest medical trade fair, MEDICA in Düsseldorf remains the top event for decision-makers from all over the world.
News & Events
Amoy Diagnostics exhibits in the18th World Conference on Lung Cancer(WCLC) in Yokohama, Japan
The 18th World Conference on Lung Cancer (WCLC) was held in Yokohama, Japan this week. It is the world’s largest meeting dedicated to lung cancer and other thoracic malignancies, organized by
News & Events
Detection sensitivity or therapeutic response prediction accuracy, which weighs more on NSCLC EGFR blood testing?
Recently an AURA 17 extension study was presented at the 2017 EMSO (European Society for Medical Oncology) Annual Congress in Madrid by experts on lung cancer from China. and the study evaluated the efficacy
News & Events
AmoyDx attended News Conference of Xalkori ROS1 approval in Japan
On June 23, Pfizer Oncology and Merck KGaA held a News Conference in Tokyo launching Xalkori (Crizotinib) ROS1 approval for additional indication. Xalkori, as a lung cancer targeted drug developed by Pfizer.
News & Events
AmoyDx to develop CDx for CANbridge Glioblastoma Candidate
CANbridge Life Sciences will partner with Amoy Diagnostics Co., Ltd. (AmoyDx) to develop a companion diagnostic for its lead candidate, the glioblastoma multiforme (GBM) treatment CAN008, the companies said today, through a collaboration whose value was n
News & Events
AmoyDx in European Lung Cancer Conference (ELCC) 2017
The European Lung Cancer Conference (ELCC) is a collaborative effort of the most important multidisciplinary societies representing thoracic oncology specialists, all working towards a shared goal: to advance
News & Events
AmoyDx HER2 Mutation Test Acting as Companion Diagnostics for Boehringer Ingelheim's Afatinib Study in NSCLC Patients
Recently Boehringer Ingelheim launched a Phase II study of Afatinib (Identifier: NCT02597946) to evaluate its efficacy and safety in advanced patients with advanced Non-Small Cell Lung Cancer (NSCLC)
News & Events
AmoyDx ROS1 Fusion Test Kit was Approved by Japanese Authority as Companion Diagnostics Kit for Pfizer's Crizotinib
February 3, 2017 – Amoy Diagnostics of Xiamen, China today announced that it has received regulatory approval from Japan's Pharmaceuticals and Medical Devices Agency (PMDA) for its ROS1 fusion PCR assay as a
News & Events
Boehringer Ingelheim and AmoyDx Collaborate to Initiate Blood-based EGFR Mutation Testing in China
· Blood-based EGFR mutation testing with AmoyDx’s novel and highly sensitive real-time PCR technology, SuperARMS®, will be made available in China in 2017.
News & Events
Merck and AmoyDx Collaborate to Bring Liquid Biopsy RAS Biomarker Testing to China
· Liquid biopsy RAS biomarker test based upon AmoyDx's real-time PCR technology, ADx-SuperARMS®, will be made available in China in 2017 · Merck is the first pharmaceutical company to collaborate with multiple
News & Events
AmoyDx ROS1 Diagnostics Test Contributed to a Phase 2 Clinical Study of Crizotinib in Lung Cancer
June 14, 2016, Xiamen, China -- Amoy Diagnostics Co, Ltd. (AmoyDx), a leading provider of cancer molecular diagnostic products and services, announced today that its AmoyDx®ROS1 test successfully supported
News & Events
Amoy Diagnostics Achieved CFDA Approval For Its EGFR&ALK&ROS1 Testing Kit
Amoy Diagnostics Co., Ltd. (AmoyDx), a provider of oncology molecular diagnostics products and services, announced today that it has got Chinese FDA (CFDA) approval for its multiple gene mutations detection
News & Events
Amoy Diagnostics and Illumina Enter Strategic Collaboration for Next-Generation Sequencing Cancer Diagnostics in China
XIAMEN, China & SAN DIEGO--(BUSINESS WIRE)--Amoy Diagnostics Co. Ltd. (ADx) and Illumina, Inc. (NASDAQ: ILMN) today announced a strategic collaboration to accelerate the adoption of precision medicine
News & Events
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.

Super-ARMS® 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 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.
 

Technological Principles:

The Super-ARMS® EGFR mutation kit enables detection of the following 42 EGFR mutations:

• Exon 18: G719C, G719A, G719S

• Exon 19: 29 deletions

• Exon 20: T790M, S768I, 6 insertions

• Exon 21: L858R, L861Q

PRODUCTS
EGFR 29 Mutations Detection Kit

EGFR 29 Mutations Detection Kit

The AmoyDx EGFR Mutations Detection Kit is a sensitive and selective assay for the detection of the most informative somatic mutations in the epidermal growth factor receptor (EGFR) gene. It is used clinically in China to select NSCLC patients who are most likely to respond to Iressa (Gefitinib) or Tarceva (Erlotinib). AmoyDx works closely with AstraZeneca in China to promote the use of molecular diagnostic tests for patient stratification.

The EGFR assay tests for a total of 29 mutations in eight PCR tubes, including both activating and resistance mutations. The presence of activating mutations indicates predicted response to mutant EGFR-targeting drugs. If the tumor tissue harbors resistance mutations, it may respond poorly to therapies designed to inhibit EGFR signalling.

The American Society for Clinical Oncology (ASCO) recommends that patients with NSCLC who are being considered for first-line therapy with an EGFR TKI (patients who have not previously received chemotherapy or an EGFR TKI) should have their tumor tested for EGFR mutations to determine whether an EGFR TKI or chemotherapy is the appropriate first-line therapy. (Keedy, V.L. et al. (2011) J. Clin. Oncol. 29(15), 2121).

The European Committee for Medicinal Products for Human Use (CHMP) recommended that EGFR mutation status be tested in patients with metastatic non-small cell lung cancer to predict sensitivity to Iressa. (EPAR summary for the public. EMEA/280173/2009. EMEA/H/C/1016).

Technological Principles:

The EGFR kit employs proprietary real-time PCR technology to detect 29 mutations in the EGFR gene. Target DNA is amplified with mutation-specific PCR primers, and the mutant amplicons are detected with a novel fluorescent probe. For high quality DNA, about 2 ng of purified DNA is added to each PCR tube. For DNA from FFPE tissue older than three years, 10 to 15 ng of DNA is recommended. The test can detect mutations at a sensitivity of 1% ( i.e., one mutant copy to 99 wild-type copies).

The EGFR mutation kit enables detection of the following mutations:

•T790M

• L858R

• L861Q

• S768I

• G719SG719A and G719C

• 3 insertions in exon 20 (detects the presence of any of 3 insertions but does not distinguish between them)

• 19 deletions in exon 19 (detects the presence of any of the 19 deletions but does not distinguish between them).

PRODUCTS
EGFR/ALK/ROS1 Mutations Detection Kit

EGFR/ALK/ROS1Mutations Detection Kit

Detection of 18 EGFR mutations (exons 18-21), 5 ALK gene fusions and 9 ROS1 gene fusions.

EGFR, ALK and ROS1 are the most common molecular targets for targeted therapies in a subset of patients with non-small cell lung cancer (NSCLC). EGFR mutations, ALK and ROS1 gene fusions are shown to be effective therapeutic targets of tyrosine kinase inhibitors (TKIs).

NSCLC patients with sensitizing EGFR mutations are most likely to respond to Iressa (Gefitinib), Tarceva (Erlotinib) or Afatinib (Boehringer Ingelheim). And NSCLC patients with ALK and ROS1 fusions are shown to respond to treatment with Xalkori (Pfizer).

NCCN Clinical Practice Guideline for non-small cell lung cancer clearly indicates that all patients with NSCLC should conduct EGFR mutation testing and ALK testing before TKIs treatment. If both sensitizing EGFR mutation and ALK are negative or unknown, consider ROS1 testing.

The AmoyDx® EGFR/ALK/ROS1MutationsDetection Kit is a one-step real-time PCR test (combined Reverse transcription and PCR amplification) intended for qualitative detection of 18 EGFRmutations (exons 18-21), 5 ALKGene Fusions and 9 ROS1 Gene Fusions.

Technological Principles

The kit contains RNA gene fusion and DNA gene mutation detection system.

The RNA gene fusion detection system uses novel, specific primers and fluorescent probes and combines a one-step RT-PCR procedure, which comprises reverse transcription of target RNA and reference gene RNA to generate complementary DNA (cDNA) and simultaneous PCR amplification of cDNA to detect ALK and ROS1 gene fusions.

The DNA gene mutation detection system uses ADx-ARMS technology, which comprises novel, specific primers and fluorescent probes to detect mutations and reference gene in a real-time PCR assay. The mutant DNA is amplified accurately by the specific primers, and detected by the novel probes. Highly Specific primers and probes, and a highly validated procedure based on Taq DNA polymerase contribute to outstanding assay sensitivity and selectivity.

PRODUCTS
KRAS Mutation Detection Kit
KRAS Mutation Detection Kit
Detection of 19 mutations in KRAS codons 12, 13, 59, 61, 117 and 146
KRAS protein is a small GTPase and one of the key molecules in the downstream signaling pathway of epidermal growth factor receptor (EGFR). KRAS protein transduces signals from membrane-bound receptors via multiple downstream effector pathways and thereby affects fundamental cellular processes, including proliferation, apoptosis, and differentiation.
KRAS mutations are particularly common in colon cancer, lung cancer, and pancreatic cancer. In total, activating mutations in the KRAS genes occur in 15~30% of lung cancer and 20~50% of colorectal cancer, mainly in exons 2, 3 or 4.
The KRAS gene mutation status of colorectal cancer patients is relevant to drug resistance of targeted medicines such as tyrosine kinase inhibitors. Patients with wild-type KRAS gene are much more likely to benefit from the Erbitux (Cetuximab) or Vectibix (Panitumumab), compared to patients with a mutant KRAS gene. The European Drug Administration Organization and US FDA recommend the employment of a KRAS gene mutation test prior to the usage of targeted medicine Erbitux and and Vectibix in the treatment of colorectal cancer.
Technological Principles
The kit uses novel, patented primers and probes to detect mutations in a real-time PCR assay. The mutant DNA is amplified accurately by the specific primers, and detected by the novel probes. Highly specific primers and probes, and a highly validated procedure based on Taq DNA polymerase contribute to outstanding assay sensitivity and selectivity.
 
PRODUCTS
KRAS/NRAS Mutations Detection Kit

KRAS/NRAS Mutations Detection Kit

Detection of 19 KRAS mutations (exons 2, 3 and 4) and 13 NRAS mutations (exons 2, 3 and 4) RAS protein is a GTPase and one of the key molecules in the downstream signaling pathway of epidermal growth factor receptor (EGFR). These pathways control cell proliferation, differentiation and apoptosis. Frequency of KRAS and NRAS mutations in colorectal cancer are 36~40% and 1~6% respectively. Most frequent mutations are in exons 2, 3 and 4.

RAS mutation is predictive of a very poor response to cetuximab (Erbitux®) and panitumumab (Vectibix®) therapy in colorectal cancer (CRC).[1] The most reliable way to predict whether a colorectal cancer patient will respond to one of the EGFR-inhibiting drugs is to test for activating mutations in the RAS gene.

A number of large studies [2][3] have shown that cetuximab has significant efficacy in mCRC patients with RAS wild-type tumors. NCCN clearly indicates that all patients with metastatic colorectal cancer should be determined of tumor RAS (KRAS/NRAS) gene status. Patients with any known KRAS or NRAS mutation should not be treated with either cetuximab or panitumumab. [4]

Technological Principles

The kit uses novel, patented primers and probes to detect mutations in a real-time PCR assay.

The mutant DNA is amplified accurately by the specific primers, and detected by the novel probes.

Highly Specific primers and probes, and a highly validated procedure based on Taq DNA

polymerase contribute to outstanding assay sensitivity and selectivity.

The AmoyDx® KRAS/NRAS Mutations Detection Kit is a real-time PCR test intended for qualitative detection of 19 KRAS mutations(exons 2, 3 and 4) and 13 NRAS mutations(exons 2, 3 and 4).

References:

1) Lièvre et al. (2006). Cancer Res. 66 (8): 3992–5.

2) Bokemeyer et al, (2009). J. Clin. Oncol. 27 (5): 663–71.

3) Van Cutsem et al. (2009). N. Engl. J. Med. 360 (14): 1408–17.

4) NCCN Clinical Practice Guidelines in Oncology™, Colon cancer. V1.2015

 

PRODUCTS
KRAS/NRAS/BRAF Mutations Detection Kit

KRAS/NRAS/BRAF Mutations Detection Kit

Detection of 17 KRAS mutations (exons 2, 3 and 4), 13 NRAS mutations (exons 2, 3 and 4) and six BRAF V600 mutations (exon 15)

KRAS, NRAS and BRAF genes are the key molecules in the downstream signaling pathway of epidermal growth factor receptor (EGFR). These pathways control cell proliferation,differentiation and apoptosis.Frequency of KRAS, NRAS and BRAF mutations in colorectal cancer are 36~40%, 1~6% and 8~15% respectively. Most frequent mutations occur in exons 2, 3 and 4 of RAS gene, and in codon 600 of BRAF gene.

KRAS mutations and NRAS mutations predict a lack of response to cetuximab (Erbitux®) and panitumumab (Vectibix®) therapy in colorectal cancer (CRC).[1]A number oflarge studies[2][3] have shown that cetuximab has significant efficacy in mCRCpatients with RAS wild-type tumors.And mutations in BRAF gene are a strong prognostic marker. Clinical data has shown that colorectal cancer patients with mutant BRAF gene are less likely to response to EGFR-TKIs therapy. NCCN Clinical Practice Guideline for colon cancer clearly indicates that all patients with metastatic colorectal cancer should be determined of tumor RAS (KRAS/NRAS) and BRAF genes status.

The AmoyDx®KRAS/NRAS/BRAFMutationsDetection Kit is a real-time PCR test intended for qualitative detection of 17 KRASmutations(exons 2, 3 and 4),13 NRASmutations(exons 2, 3 and 4)and six BRAF V600mutations(exon 15).

Technological Principles

The kit uses novel, patented primers and probes to detect mutations in a real-time PCR assay.

The mutant DNA is amplified accurately by the specific primers, and detected by the novel probes.

Highly Specific primers and probes, and a highly validated procedure based on Taq DNA polymerase contribute to outstanding assay sensitivity and selectivity.

PRODUCTS
Essential NGS Panel

Essential NGS Panel

The AmoyDx® Essential NGS Panel (Reversible Terminator Sequencing) based on Next Generation Sequencing (NGS) technology, used for detection of common mutations in 10 genes including EGFR, ALK, ROS1, RET, KRAS, NRAS, PIK3CA, BRAF, HER2 and MET in lung adenocarcinoma and colorectal cancer patients. The test results are for clinical reference only. The clinician should judge the test results based on the patient's condition, drug indications, treatment response and other laboratory test indicators comprehensively.

Technological Principles

The kit is developed based on constructing DNA sequencing library, enriching the target regions in the library with specific probes and the Next Generation Sequencing technology to accomplish the one-time detection of multiple mutations in various genes. For FFPE samples, the extracted DNA is sheared into fragments firstly, then the fragments are selected by Ampure XP magnetic beads (for plasma samples, the extracted DNA fragments can be used directly). The selected DNA fragments are performed with end repair, dA-tailing. The Adaptor is attached to the ends of end-repaired and dA-tailing reaction product by  DNA ligase. Then the PCR is performed with the primers with Index and the polymerase to obtain the amplified library. The amplified library and the biotinylated DNA probe undergo solution hybridization, and then the streptavidin coupled magnetic beads is used to enrich the library combined with the probe. Then the PCR is performed to obtain the captured library. The captured library undergoes high-throughput sequencing to obtain sequencing data from which the gene variant information is obtained by analyzing the data with matched software.

PRODUCTS
HER-2 Gene Amplification Analysis Kit

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™.

Technological Principles

The kit uses fluorescence in situ hybridization (FISH) technology, which employs a dual-color HER-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 counter stain 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.

PRODUCTS
P-EGFR-L2-01 Liquid biopsy and PCR-free ultrasensitive detection systems in oncology (Review)
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EGFR-L2-07 KRAS-L2-03 BRAF-L2-03 PIK3CA-L2-01 ROS1-L2-02 Molecular alterations and clinical prognostic factors for
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EGFR-L2-06 EGFR T790M mutation testing of non-small cell lung cancer tissue and blood samples artificially spiked with
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EGFR-L2-05 Gefitinib Treatment in EGFR Mutated Caucasian NSCLC Circulating-Free Tumor DNA as a Surrogate for Determination
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EGFR-L2-04 Evaluation of pre-analytical conditions and comparison of the performance of several digital PCR assays
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EGFR-L2-03 EGFR mutation prevalence in Asia-Pacific and Russian patients with advanced NSCLC of adenocarcinoma
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EGFR-L2-02 Epidermal growth factor receptor exon 20 p.S768I mutation in non-small cell lung carcinoma A case report
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EGFR-L2-01 Molecular pathology in lung cancer a guide to the techniques used in clinical practice
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BRAF-L2-01 Comparison of Targeted Next-Generation Sequencing (NGS) and Real-Time PCR in the Detection of EGFR, KRAS, and BRAF
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MSDS-Super-ARMS EGFR-201804
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MSDS-Super-ARMS EGFR T790M-201804
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Super-ARMS® EGFR C797S Mutation Detection Kit-B1.0-12T
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MSDS-Super-ARMS EGFR Color Compensation kit -201804
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P-T790M-L1-01 Detection of EGFR T790M in Asia-Pacific patients with EGFR mutation-positive advanced NSCLC circulating tumour DNA
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P-EGFR-L1-03 Use of SuperARMS EGFR Mutation Detection Kit to Detect EGFR in Plasma Cell-free DNA of Patients With Lung
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P-EGFR-L1-02 Comparison of the SuperARMS and Droplet Digital PCR for Detecting EGFR Mutation in ctDNA From NSCLC
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P-EGFR-L1-01 Clinical validation of a highly sensitive assay to detect EGFR mutations in plasma cell-free DNA from patients
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AmoyDx® EGFR.ALK.ROS1 Mutations Detection Kit-P2.2-8T
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HER2-L1-01 Epidemiological study of HER-2 mutations among EGFR wild-type lung adenocarcinoma patients in China.
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MSDS-EGFR-201804
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EGFR-L1-06 EML4-ALK-L1-01 Intratumoral Heterogeneity of ALK-Rearranged and ALK_EGFR Coaltered Lung Adenocarcinoma
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MSDS-EGFR ALK ROS1-201804
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EGFR-L1-05 Comparison of plasma and tissue samples in epidermal growth factor receptor mutation by ARMS
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Super-ARMS® EGFR T790M Mutation Detection Kit-B2.2-24T
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EGFR-L1-04 Prevalence and Clinical Profile of EGFR Mutation In Non- Small-Cell Lung Carcinoma Patients in Southwest China.
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Super-ARMS® EGFR Mutation Detection Kit-B1.2-12T
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EGFR-L1-03 ARMS for EGFR mutation analysis of cytologic and corresponding lung adenocarcinoma histologic specimens
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Color Compensation Instruction for P-EGFR-B1.1-J-12T
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EGFR-L1-02 Sensitive Detection of EGFR Mutations in Cerebrospinal Fluid from Lung Adenocarcinoma Patients with Brain Metastases
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AmoyDx® EGFR 29 Mutations Detection Kit-B3.2-24T-CE-RGQ
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2. EGFR-2017.9
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EGFR-L1-01 The diagnostic accuracy of pleural effusion and plasma samples versus tumour tissue for detection of EGFR mutation
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AmoyDx® EGFR 29 Mutations Detection Kit-B4.3-24T
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Relationship between KRAS and EGFR gene mutations and clinicopathological features in patients with non-small cell lung cancer in China
Zhang Jiexia, Li Shiyue, Zhan Yangqing, Ouyang Ming
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no more...
Visit AmoyDx at the 19th World Conference on Lung Cancer (WCLC) 2018 in Canada
Amoy Diagnostics will be exhibiting at 19th World Conference on Lung Cancer 2018 of IASLC in Toronto, Canada. Welcome to visit us at booth 206.
News & Events
Amoy Diagnostics achieved China NMPA Approval of Multi-Genes Mutations Detection Kit
Amoy Diagnostics Co., Ltd. (AmoyDx, SHE:300685) announced that NMPA(National Medical Products Administration)approved its Multi-Genes Mutations Detection Kit on Aug 24, 2018.
News & Events
Meet AmoyDx at ELCC 2018 in Switzerland for NSCLC Molecular Testing
Amoy Diagnostics will be exhibiting at the ELCC 2018 in Geneva, Switzerland. Welcome to visit us.  The exhibition details are below.
News & Events
China NMPA grants approval to AmoyDx Super-ARMS EGFR mutation test kit
(January 22, 2018, Xiamen China)  Amoy Diagnostics Co., Ltd. (AmoyDx, SZ:300685)  announced that NMPA(National Medical Products Administration)approved AmoyDx Super-ARMS® EGFR mutation test kit
News & Events
AmoyDx Distributors Annual Meeting (APAC-MEAF) 2017
AmoyDx Distributors Annual Meeting (APAC-MEAF) 2017 was held in Xiamen, China on December 4. Distributors from different countries gathered to get the recent update on precision oncology
News & Events
AmoyDx Distributors Annual Meeting (Europe) 2017
AmoyDx Distributors Annual Meeting (Europe) 2017 was held in Dusseldorf, Germany on November 15. Distributors from different European countries gathered to get the recent update on precision oncology
News & Events
Visit AmoyDx at MEDICA 2017, Germany
As the world’s largest medical trade fair, MEDICA in Düsseldorf remains the top event for decision-makers from all over the world.
News & Events
Amoy Diagnostics exhibits in the18th World Conference on Lung Cancer(WCLC) in Yokohama, Japan
The 18th World Conference on Lung Cancer (WCLC) was held in Yokohama, Japan this week. It is the world’s largest meeting dedicated to lung cancer and other thoracic malignancies, organized by
News & Events
Detection sensitivity or therapeutic response prediction accuracy, which weighs more on NSCLC EGFR blood testing?
Recently an AURA 17 extension study was presented at the 2017 EMSO (European Society for Medical Oncology) Annual Congress in Madrid by experts on lung cancer from China. and the study evaluated the efficacy
News & Events
AmoyDx attended News Conference of Xalkori ROS1 approval in Japan
On June 23, Pfizer Oncology and Merck KGaA held a News Conference in Tokyo launching Xalkori (Crizotinib) ROS1 approval for additional indication. Xalkori, as a lung cancer targeted drug developed by Pfizer.
News & Events
AmoyDx to develop CDx for CANbridge Glioblastoma Candidate
CANbridge Life Sciences will partner with Amoy Diagnostics Co., Ltd. (AmoyDx) to develop a companion diagnostic for its lead candidate, the glioblastoma multiforme (GBM) treatment CAN008, the companies said today, through a collaboration whose value was n
News & Events
AmoyDx in European Lung Cancer Conference (ELCC) 2017
The European Lung Cancer Conference (ELCC) is a collaborative effort of the most important multidisciplinary societies representing thoracic oncology specialists, all working towards a shared goal: to advance
News & Events
AmoyDx HER2 Mutation Test Acting as Companion Diagnostics for Boehringer Ingelheim's Afatinib Study in NSCLC Patients
Recently Boehringer Ingelheim launched a Phase II study of Afatinib (Identifier: NCT02597946) to evaluate its efficacy and safety in advanced patients with advanced Non-Small Cell Lung Cancer (NSCLC)
News & Events
AmoyDx ROS1 Fusion Test Kit was Approved by Japanese Authority as Companion Diagnostics Kit for Pfizer's Crizotinib
February 3, 2017 – Amoy Diagnostics of Xiamen, China today announced that it has received regulatory approval from Japan's Pharmaceuticals and Medical Devices Agency (PMDA) for its ROS1 fusion PCR assay as a
News & Events
Boehringer Ingelheim and AmoyDx Collaborate to Initiate Blood-based EGFR Mutation Testing in China
· Blood-based EGFR mutation testing with AmoyDx’s novel and highly sensitive real-time PCR technology, SuperARMS®, will be made available in China in 2017.
News & Events
Merck and AmoyDx Collaborate to Bring Liquid Biopsy RAS Biomarker Testing to China
· Liquid biopsy RAS biomarker test based upon AmoyDx's real-time PCR technology, ADx-SuperARMS®, will be made available in China in 2017 · Merck is the first pharmaceutical company to collaborate with multiple
News & Events
AmoyDx ROS1 Diagnostics Test Contributed to a Phase 2 Clinical Study of Crizotinib in Lung Cancer
June 14, 2016, Xiamen, China -- Amoy Diagnostics Co, Ltd. (AmoyDx), a leading provider of cancer molecular diagnostic products and services, announced today that its AmoyDx®ROS1 test successfully supported
News & Events
Amoy Diagnostics Achieved CFDA Approval For Its EGFR&ALK&ROS1 Testing Kit
Amoy Diagnostics Co., Ltd. (AmoyDx), a provider of oncology molecular diagnostics products and services, announced today that it has got Chinese FDA (CFDA) approval for its multiple gene mutations detection
News & Events
Amoy Diagnostics and Illumina Enter Strategic Collaboration for Next-Generation Sequencing Cancer Diagnostics in China
XIAMEN, China & SAN DIEGO--(BUSINESS WIRE)--Amoy Diagnostics Co. Ltd. (ADx) and Illumina, Inc. (NASDAQ: ILMN) today announced a strategic collaboration to accelerate the adoption of precision medicine
News & Events
no more...
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.

Super-ARMS® 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 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.
 

Technological Principles:

The Super-ARMS® EGFR mutation kit enables detection of the following 42 EGFR mutations:

• Exon 18: G719C, G719A, G719S

• Exon 19: 29 deletions

• Exon 20: T790M, S768I, 6 insertions

• Exon 21: L858R, L861Q

PRODUCTS
EGFR 29 Mutations Detection Kit

EGFR 29 Mutations Detection Kit

The AmoyDx EGFR Mutations Detection Kit is a sensitive and selective assay for the detection of the most informative somatic mutations in the epidermal growth factor receptor (EGFR) gene. It is used clinically in China to select NSCLC patients who are most likely to respond to Iressa (Gefitinib) or Tarceva (Erlotinib). AmoyDx works closely with AstraZeneca in China to promote the use of molecular diagnostic tests for patient stratification.

The EGFR assay tests for a total of 29 mutations in eight PCR tubes, including both activating and resistance mutations. The presence of activating mutations indicates predicted response to mutant EGFR-targeting drugs. If the tumor tissue harbors resistance mutations, it may respond poorly to therapies designed to inhibit EGFR signalling.

The American Society for Clinical Oncology (ASCO) recommends that patients with NSCLC who are being considered for first-line therapy with an EGFR TKI (patients who have not previously received chemotherapy or an EGFR TKI) should have their tumor tested for EGFR mutations to determine whether an EGFR TKI or chemotherapy is the appropriate first-line therapy. (Keedy, V.L. et al. (2011) J. Clin. Oncol. 29(15), 2121).

The European Committee for Medicinal Products for Human Use (CHMP) recommended that EGFR mutation status be tested in patients with metastatic non-small cell lung cancer to predict sensitivity to Iressa. (EPAR summary for the public. EMEA/280173/2009. EMEA/H/C/1016).

Technological Principles:

The EGFR kit employs proprietary real-time PCR technology to detect 29 mutations in the EGFR gene. Target DNA is amplified with mutation-specific PCR primers, and the mutant amplicons are detected with a novel fluorescent probe. For high quality DNA, about 2 ng of purified DNA is added to each PCR tube. For DNA from FFPE tissue older than three years, 10 to 15 ng of DNA is recommended. The test can detect mutations at a sensitivity of 1% ( i.e., one mutant copy to 99 wild-type copies).

The EGFR mutation kit enables detection of the following mutations:

•T790M

• L858R

• L861Q

• S768I

• G719SG719A and G719C

• 3 insertions in exon 20 (detects the presence of any of 3 insertions but does not distinguish between them)

• 19 deletions in exon 19 (detects the presence of any of the 19 deletions but does not distinguish between them).

PRODUCTS
EGFR/ALK/ROS1 Mutations Detection Kit

EGFR/ALK/ROS1Mutations Detection Kit

Detection of 18 EGFR mutations (exons 18-21), 5 ALK gene fusions and 9 ROS1 gene fusions.

EGFR, ALK and ROS1 are the most common molecular targets for targeted therapies in a subset of patients with non-small cell lung cancer (NSCLC). EGFR mutations, ALK and ROS1 gene fusions are shown to be effective therapeutic targets of tyrosine kinase inhibitors (TKIs).

NSCLC patients with sensitizing EGFR mutations are most likely to respond to Iressa (Gefitinib), Tarceva (Erlotinib) or Afatinib (Boehringer Ingelheim). And NSCLC patients with ALK and ROS1 fusions are shown to respond to treatment with Xalkori (Pfizer).

NCCN Clinical Practice Guideline for non-small cell lung cancer clearly indicates that all patients with NSCLC should conduct EGFR mutation testing and ALK testing before TKIs treatment. If both sensitizing EGFR mutation and ALK are negative or unknown, consider ROS1 testing.

The AmoyDx® EGFR/ALK/ROS1MutationsDetection Kit is a one-step real-time PCR test (combined Reverse transcription and PCR amplification) intended for qualitative detection of 18 EGFRmutations (exons 18-21), 5 ALKGene Fusions and 9 ROS1 Gene Fusions.

Technological Principles

The kit contains RNA gene fusion and DNA gene mutation detection system.

The RNA gene fusion detection system uses novel, specific primers and fluorescent probes and combines a one-step RT-PCR procedure, which comprises reverse transcription of target RNA and reference gene RNA to generate complementary DNA (cDNA) and simultaneous PCR amplification of cDNA to detect ALK and ROS1 gene fusions.

The DNA gene mutation detection system uses ADx-ARMS technology, which comprises novel, specific primers and fluorescent probes to detect mutations and reference gene in a real-time PCR assay. The mutant DNA is amplified accurately by the specific primers, and detected by the novel probes. Highly Specific primers and probes, and a highly validated procedure based on Taq DNA polymerase contribute to outstanding assay sensitivity and selectivity.

PRODUCTS
KRAS Mutation Detection Kit
KRAS Mutation Detection Kit
Detection of 19 mutations in KRAS codons 12, 13, 59, 61, 117 and 146
KRAS protein is a small GTPase and one of the key molecules in the downstream signaling pathway of epidermal growth factor receptor (EGFR). KRAS protein transduces signals from membrane-bound receptors via multiple downstream effector pathways and thereby affects fundamental cellular processes, including proliferation, apoptosis, and differentiation.
KRAS mutations are particularly common in colon cancer, lung cancer, and pancreatic cancer. In total, activating mutations in the KRAS genes occur in 15~30% of lung cancer and 20~50% of colorectal cancer, mainly in exons 2, 3 or 4.
The KRAS gene mutation status of colorectal cancer patients is relevant to drug resistance of targeted medicines such as tyrosine kinase inhibitors. Patients with wild-type KRAS gene are much more likely to benefit from the Erbitux (Cetuximab) or Vectibix (Panitumumab), compared to patients with a mutant KRAS gene. The European Drug Administration Organization and US FDA recommend the employment of a KRAS gene mutation test prior to the usage of targeted medicine Erbitux and and Vectibix in the treatment of colorectal cancer.
Technological Principles
The kit uses novel, patented primers and probes to detect mutations in a real-time PCR assay. The mutant DNA is amplified accurately by the specific primers, and detected by the novel probes. Highly specific primers and probes, and a highly validated procedure based on Taq DNA polymerase contribute to outstanding assay sensitivity and selectivity.
 
PRODUCTS
KRAS/NRAS Mutations Detection Kit

KRAS/NRAS Mutations Detection Kit

Detection of 19 KRAS mutations (exons 2, 3 and 4) and 13 NRAS mutations (exons 2, 3 and 4) RAS protein is a GTPase and one of the key molecules in the downstream signaling pathway of epidermal growth factor receptor (EGFR). These pathways control cell proliferation, differentiation and apoptosis. Frequency of KRAS and NRAS mutations in colorectal cancer are 36~40% and 1~6% respectively. Most frequent mutations are in exons 2, 3 and 4.

RAS mutation is predictive of a very poor response to cetuximab (Erbitux®) and panitumumab (Vectibix®) therapy in colorectal cancer (CRC).[1] The most reliable way to predict whether a colorectal cancer patient will respond to one of the EGFR-inhibiting drugs is to test for activating mutations in the RAS gene.

A number of large studies [2][3] have shown that cetuximab has significant efficacy in mCRC patients with RAS wild-type tumors. NCCN clearly indicates that all patients with metastatic colorectal cancer should be determined of tumor RAS (KRAS/NRAS) gene status. Patients with any known KRAS or NRAS mutation should not be treated with either cetuximab or panitumumab. [4]

Technological Principles

The kit uses novel, patented primers and probes to detect mutations in a real-time PCR assay.

The mutant DNA is amplified accurately by the specific primers, and detected by the novel probes.

Highly Specific primers and probes, and a highly validated procedure based on Taq DNA

polymerase contribute to outstanding assay sensitivity and selectivity.

The AmoyDx® KRAS/NRAS Mutations Detection Kit is a real-time PCR test intended for qualitative detection of 19 KRAS mutations(exons 2, 3 and 4) and 13 NRAS mutations(exons 2, 3 and 4).

References:

1) Lièvre et al. (2006). Cancer Res. 66 (8): 3992–5.

2) Bokemeyer et al, (2009). J. Clin. Oncol. 27 (5): 663–71.

3) Van Cutsem et al. (2009). N. Engl. J. Med. 360 (14): 1408–17.

4) NCCN Clinical Practice Guidelines in Oncology™, Colon cancer. V1.2015

 

PRODUCTS
KRAS/NRAS/BRAF Mutations Detection Kit

KRAS/NRAS/BRAF Mutations Detection Kit

Detection of 17 KRAS mutations (exons 2, 3 and 4), 13 NRAS mutations (exons 2, 3 and 4) and six BRAF V600 mutations (exon 15)

KRAS, NRAS and BRAF genes are the key molecules in the downstream signaling pathway of epidermal growth factor receptor (EGFR). These pathways control cell proliferation,differentiation and apoptosis.Frequency of KRAS, NRAS and BRAF mutations in colorectal cancer are 36~40%, 1~6% and 8~15% respectively. Most frequent mutations occur in exons 2, 3 and 4 of RAS gene, and in codon 600 of BRAF gene.

KRAS mutations and NRAS mutations predict a lack of response to cetuximab (Erbitux®) and panitumumab (Vectibix®) therapy in colorectal cancer (CRC).[1]A number oflarge studies[2][3] have shown that cetuximab has significant efficacy in mCRCpatients with RAS wild-type tumors.And mutations in BRAF gene are a strong prognostic marker. Clinical data has shown that colorectal cancer patients with mutant BRAF gene are less likely to response to EGFR-TKIs therapy. NCCN Clinical Practice Guideline for colon cancer clearly indicates that all patients with metastatic colorectal cancer should be determined of tumor RAS (KRAS/NRAS) and BRAF genes status.

The AmoyDx®KRAS/NRAS/BRAFMutationsDetection Kit is a real-time PCR test intended for qualitative detection of 17 KRASmutations(exons 2, 3 and 4),13 NRASmutations(exons 2, 3 and 4)and six BRAF V600mutations(exon 15).

Technological Principles

The kit uses novel, patented primers and probes to detect mutations in a real-time PCR assay.

The mutant DNA is amplified accurately by the specific primers, and detected by the novel probes.

Highly Specific primers and probes, and a highly validated procedure based on Taq DNA polymerase contribute to outstanding assay sensitivity and selectivity.

PRODUCTS
Essential NGS Panel

Essential NGS Panel

The AmoyDx® Essential NGS Panel (Reversible Terminator Sequencing) based on Next Generation Sequencing (NGS) technology, used for detection of common mutations in 10 genes including EGFR, ALK, ROS1, RET, KRAS, NRAS, PIK3CA, BRAF, HER2 and MET in lung adenocarcinoma and colorectal cancer patients. The test results are for clinical reference only. The clinician should judge the test results based on the patient's condition, drug indications, treatment response and other laboratory test indicators comprehensively.

Technological Principles

The kit is developed based on constructing DNA sequencing library, enriching the target regions in the library with specific probes and the Next Generation Sequencing technology to accomplish the one-time detection of multiple mutations in various genes. For FFPE samples, the extracted DNA is sheared into fragments firstly, then the fragments are selected by Ampure XP magnetic beads (for plasma samples, the extracted DNA fragments can be used directly). The selected DNA fragments are performed with end repair, dA-tailing. The Adaptor is attached to the ends of end-repaired and dA-tailing reaction product by  DNA ligase. Then the PCR is performed with the primers with Index and the polymerase to obtain the amplified library. The amplified library and the biotinylated DNA probe undergo solution hybridization, and then the streptavidin coupled magnetic beads is used to enrich the library combined with the probe. Then the PCR is performed to obtain the captured library. The captured library undergoes high-throughput sequencing to obtain sequencing data from which the gene variant information is obtained by analyzing the data with matched software.

PRODUCTS
HER-2 Gene Amplification Analysis Kit

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™.

Technological Principles

The kit uses fluorescence in situ hybridization (FISH) technology, which employs a dual-color HER-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 counter stain 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.

PRODUCTS
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