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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
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
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
NRAS Mutation Detection Kit

NRAS Mutation Detection Kit

Detection of 16 mutations in NRAS codons 12, 13, 59, 61, 117 and 146

NRAS is a member of the RAS family of small GTPases and plays a central role in the MAPK signaling pathways. NRAS has been implicated in the pathogenesis of several cancers. NRAS mutations are particularly common in melanoma, hepatocellular carcinoma, myeloid leukemias, and thyroid carcinoma. In total, activating mutations in the NRAS genes occur in 13~25% of cutaneous melanomas, 1~6% of colorectal cancer and 1% of lung cancer, mainly in exons 2, 3 or 4.

The mutation status of NRAS gene is relevant to drug resistance of non-small cell lung cancer treated with tyrosine kinase inhibitors. As a result, NRAS mutations detection supplies evidence for targeted clinical therapy of tumor patients.

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
BRAF-L2-02 BRAFV600E and NRASQ61L_Q61R mutation analysis in metastatic melanoma using immunohistochemistry_ a study of 754 cases
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MSDS-Super-ARMS KRAS&NRAS&BRAF-201804
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MSDS-NRAS-201804
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Super-ARMS® KRASNRASBRAF Mutations Detection Kit-B2.2-24T
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MSDS-KRAS&NRAS&BRAF Panel-201804
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AmoyDx® KRASNRASBRAF Mutations Detection Kit-P2.1-6T
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MSDS-KRAS&NRAS Panel-201804
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AmoyDx® KRASNRAS Mutations Detection Kit-B2.2-24T
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AmoyDx® NRAS Mutation Detection Kit-B2.3-24T
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KNBP-L1-01 Molecular spectrum of KRAS, NRAS, BRAF and PIK3CA mutations in Chinese colorectal cancer patients_ analysis of 1,110
DOWNLOAD
7. NRAS-2017
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NRAS Mutation Detection Kit

NRAS Mutation Detection Kit

Detection of 16 mutations in NRAS codons 12, 13, 59, 61, 117 and 146

NRAS is a member of the RAS family of small GTPases and plays a central role in the MAPK signaling pathways. NRAS has been implicated in the pathogenesis of several cancers. NRAS mutations are particularly common in melanoma, hepatocellular carcinoma, myeloid leukemias, and thyroid carcinoma. In total, activating mutations in the NRAS genes occur in 13~25% of cutaneous melanomas, 1~6% of colorectal cancer and 1% of lung cancer, mainly in exons 2, 3 or 4.

The mutation status of NRAS gene is relevant to drug resistance of non-small cell lung cancer treated with tyrosine kinase inhibitors. As a result, NRAS mutations detection supplies evidence for targeted clinical therapy of tumor patients.

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
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