KRAS Mutation (19) Detection Kit
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Amoy Diagnostics Co.,Ltd.
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 diagnostics partner of AstraZeneca, Boehringer-Ingelheim, Pfizer, Merck and Illumina, providing diagnostic products and services for medicine development and clinical oncology practice. AmoyDx ROS1 kit was recently approved by Japanese authority PMDA as the sole companion diagnostic kit for Pfizer’s crizotinib, which became the 1st approved CDx kit in the world for lung cancer patients’ ROS1 testing.
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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.
The AmoyDx® KRAS Mutation Detection Kit (19 mutations) is for Research Use Only (RUO).
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.
KRAS 19 mutations detected by the kit
|Exon||Mutation||Base Change||Cosmic ID||Name|
Key Features and Benefits:
• Simple Procedure — only one step required for sample application, results obtained within 90
• High sensitivity and accuracy — can detect 1-5% mutant DNA in a background of wild type
• ADx-ARMs technology — employs a patented two-step PCR amplification procedure and
novel fluorescent probe design.
• Easy Standardization — any general PCR lab can perform the test, and technicians obtain
reproducible results without specialized training.
• Reliable product quality — Produced in a dedicated GMP plant, with quality management systems
that have passed Chinese CFDA and international ISO13485 standards.
• Sample type: Fresh, frozen or paraffin embedded tissue.
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