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2018 AmoyDx Distributors Annual Meeting successfully held in Shanghai
November 11, 2018 (Shanghai, China) AmoyDx Distributors Annual Meeting 2018 was held in Shanghai on November 8, 2018. 34 delegates from 19 countries gathered together to get the latest market information and celebrate the successful collaboration in the p
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
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
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
Visit AmoyDx at WCLC 2017 of IASLC in Japan
Amoy Diagnostics will be exhibiting at the IASLC WCLC 2017 in Yokohama, Japan. Welcome to visit us.
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
Visit AmoyDx at ELCC 2017 in Switzerland
Amoy Diagnostics will be exhibiting at the ELCC 2017 in Geneva, Switzerland. Welcome to visit us. The exhibition details are below.
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
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
ROS1 Gene Fusions Detection Kit

ROS1 Gene Fusions Detection Kit

ROS1 is a receptor tyrosine kinase of insulin receptor family. Chromosomal rearrangements involving the ROS1 receptor tyrosine kinase gene occur in a subset of non–small-cell lung cancer (NSCLC). The ROS1 fusion partners include SLC34A2, CD74, SDC4, EZR etc. These fusions lead to constitutive kinase activity and activation of downstream pathways, such as JAK/STAT, PI3K/AKT, RAS/MAPK etc., leading to carcinogenesis. It has been reported that the presence of the ROS1 rearrangement is correlated with the efficacy of TKI therapy.Based on analysis of tumor messenger RNA, ROS1 gene fusions can be detected by real-time PCR method.

Amoy Diagnostics has reached an agreement with OxOnc Development to use AmoyDx ROS1 Gene Fusions Detection Kit for a pivotal clinical trial of Pfizer's Xalkori (crizotinib) in Japan, Korea and China. Additional information is available at related news.

Technological Principles:

This kit is a nucleic acid amplifcation test for the qualitative detection of ROS1 gene fusions in NSCLC FFPE samples. The kit is based on three major processes: (1) specimen preparation to isolate total RNA from NSCLC FFPE samples; (2) reverse transcription of the target RNA to generate complementary DNA (cDNA); (3) simultaneous PCR amplification of target cDNA and detection of ROS1 gene fusions with specific primers and fluorescent probes.

PRODUCTS
ALK Gene Fusions and ROS1 Gene Fusions Detection Kit

ALK Gene Fusions and ROS1Gene Fusions Detection Kit

For qualitative detection of 26 ALK gene fusions and 14 ROS1 gene fusions ALK gene fusions and ROS1 gene fusions define unique molecular subsets of non–small-cell lung cancer (NSCLC). EML4, KIF5B, TFG, KLC1 etc., are identified as fusion partners of ALK; SLC34A2, CD74, SDC4, EZR etc., are identified as fusion partners of ROS1.These fusions lead to constitutive kinase activity and activation of downstream pathways, leading to carcinogenesis.It has been reported that the presence of the ALK gene fusions and ROS1 gene fusions are correlated with the efficacy of TKI therapy.

Detection of ALK and ROS1 fusions in patients with advanced NSCLC indicates eligibility for treatment with ALK inhibitor crizotinib.

The AmoyDx® ALK Gene Fusions and ROS1 Gene Fusions Detection Kit is an in vitro nucleic acid amplification test intended for qualitative detection of 26 ALK gene fusions and 14 ROS1 gene fusions.

Technological Principles

The kit is based on three major processes:

(1) Specimen preparation to isolate total RNA from NSCLC FFPE samples;

(2) Reverse transcription of the target RNA to generate complementary DNA (cDNA);

(3) Simultaneous PCR amplification of target cDNA and detection of ROS1 gene fusions with specific primers and fluorescent probes.

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
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
ROS1-L2-01 Testing for ROS1 in non-small cell lung cancer a review with recommendations
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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
DOWNLOAD
ROS1-L1-05 A lung squamous carcinoma patient with ROS1 rearrangement sensitive to crizotinib
DOWNLOAD
ROS1-L1-04 Phase II Study of Crizotinib in East Asian Patients With ROS1-Positive Advanced Non–Small-Cell Lung Cancer
DOWNLOAD
MSDS-ROS1-201804
DOWNLOAD
ROS1-L1-03 Efficacy of crizotinib and pemetrexed-based chemotherapy in Chinese NSCLC patients with ROS1 rearrangement.
DOWNLOAD
ROS1-L1-02 Detection of lung adenocarcinoma with ROS1 rearrangement by IHC , FISH , and RT-PCR and analysis of its
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ROS1-L1-01 ROS1 fusions in Chinese patients with non-small-cell lung cancer
DOWNLOAD
AmoyDx® EGFR.ALK.ROS1 Mutations Detection Kit-P2.2-8T
DOWNLOAD
AmoyDx® ALK Gene Fusions and ROS1 Gene Fusions Detection Kit-P2.0-8T
DOWNLOAD
AmoyDx® ROS1 Gene Fusions Detection Kit-B2.1-12T
DOWNLOAD
MSDS-EGFR ALK ROS1-201804
DOWNLOAD
4. ROS1-2017.9
DOWNLOAD
MSDS-ALK&ROS1-201804
DOWNLOAD
no more...
2018 AmoyDx Distributors Annual Meeting successfully held in Shanghai
November 11, 2018 (Shanghai, China) AmoyDx Distributors Annual Meeting 2018 was held in Shanghai on November 8, 2018. 34 delegates from 19 countries gathered together to get the latest market information and celebrate the successful collaboration in the p
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
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
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
Visit AmoyDx at WCLC 2017 of IASLC in Japan
Amoy Diagnostics will be exhibiting at the IASLC WCLC 2017 in Yokohama, Japan. Welcome to visit us.
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
Visit AmoyDx at ELCC 2017 in Switzerland
Amoy Diagnostics will be exhibiting at the ELCC 2017 in Geneva, Switzerland. Welcome to visit us. The exhibition details are below.
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
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...
ROS1 Gene Fusions Detection Kit

ROS1 Gene Fusions Detection Kit

ROS1 is a receptor tyrosine kinase of insulin receptor family. Chromosomal rearrangements involving the ROS1 receptor tyrosine kinase gene occur in a subset of non–small-cell lung cancer (NSCLC). The ROS1 fusion partners include SLC34A2, CD74, SDC4, EZR etc. These fusions lead to constitutive kinase activity and activation of downstream pathways, such as JAK/STAT, PI3K/AKT, RAS/MAPK etc., leading to carcinogenesis. It has been reported that the presence of the ROS1 rearrangement is correlated with the efficacy of TKI therapy.Based on analysis of tumor messenger RNA, ROS1 gene fusions can be detected by real-time PCR method.

Amoy Diagnostics has reached an agreement with OxOnc Development to use AmoyDx ROS1 Gene Fusions Detection Kit for a pivotal clinical trial of Pfizer's Xalkori (crizotinib) in Japan, Korea and China. Additional information is available at related news.

Technological Principles:

This kit is a nucleic acid amplifcation test for the qualitative detection of ROS1 gene fusions in NSCLC FFPE samples. The kit is based on three major processes: (1) specimen preparation to isolate total RNA from NSCLC FFPE samples; (2) reverse transcription of the target RNA to generate complementary DNA (cDNA); (3) simultaneous PCR amplification of target cDNA and detection of ROS1 gene fusions with specific primers and fluorescent probes.

PRODUCTS
ALK Gene Fusions and ROS1 Gene Fusions Detection Kit

ALK Gene Fusions and ROS1Gene Fusions Detection Kit

For qualitative detection of 26 ALK gene fusions and 14 ROS1 gene fusions ALK gene fusions and ROS1 gene fusions define unique molecular subsets of non–small-cell lung cancer (NSCLC). EML4, KIF5B, TFG, KLC1 etc., are identified as fusion partners of ALK; SLC34A2, CD74, SDC4, EZR etc., are identified as fusion partners of ROS1.These fusions lead to constitutive kinase activity and activation of downstream pathways, leading to carcinogenesis.It has been reported that the presence of the ALK gene fusions and ROS1 gene fusions are correlated with the efficacy of TKI therapy.

Detection of ALK and ROS1 fusions in patients with advanced NSCLC indicates eligibility for treatment with ALK inhibitor crizotinib.

The AmoyDx® ALK Gene Fusions and ROS1 Gene Fusions Detection Kit is an in vitro nucleic acid amplification test intended for qualitative detection of 26 ALK gene fusions and 14 ROS1 gene fusions.

Technological Principles

The kit is based on three major processes:

(1) Specimen preparation to isolate total RNA from NSCLC FFPE samples;

(2) Reverse transcription of the target RNA to generate complementary DNA (cDNA);

(3) Simultaneous PCR amplification of target cDNA and detection of ROS1 gene fusions with specific primers and fluorescent probes.

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
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
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