BRAF V600 Mutations 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.
Our mission is to provide customers with superior and innovative products and services to improve healthcare and patients’ lives. Our vision is to be one of the global leading and most reliable suppliers of high quality diagnostic products and services for personalized healthcare.
We endeavor to accomplish this mission and vision by:
1. Adhering to the strictest manufacturing standards to provide quality products at competitive prices.
2. Maintaining an unsurpassed level of customer service and satisfaction.
3. Pursuing scientific innovation as we provide customers with practical leading-edge technologies and value-added products.
4. Creating a world-class organization that contributes positively to the lives of our employees, our customers, the patients and the scientific community.
The AmoyDx BRAF V600 Mutations Detection Kit is a sensitive and selective assay for the detection of the V600 (1799T>A) mutation in the BRAF oncogene.
BRAF is a serine/threonine kinase that functions within the Ras-Raf-MEK-MAPK pathway. This pathway normally regulates cell proliferation and survival under the control of growth factors and hormones. Mutations in the BRAF gene have been associated with the development of cancer. The most common alteration in the BRAF gene is a mutation called V600E, which alters the valine at position 600 in the protein to a glutamic acid. The V600E mutation causes the BRAF protein to be permanently activated even in the absence of growth factors.
Aberrant BRAF signaling due to the V600 mutations can result in excessive cell proliferation and an adverse resistance to apoptosis. BRAF mutations occur in ~50% of melanoma tumors, ~40% of papillary thyroid tumors, ~30% of ovarian tumors, ~10% of colorectal tumors and ~10% of prostate tumors. Drugs that block oncogenic BRAF signaling have had impressive results in clinical trials and the search for new BRAF-targeted drugs is an active area of research and development.
The AmoyDx® BRAF V600 Mutations Detection Kit is a highly selective and sensitive test for detecting the V600 mutations in the BRAF oncogene. AmoyDx’s patented technology allows detection of 1% mutant DNA in a background of 99% normal DNA, while ensuring that false negatives are minimized. The procedure is easily adapted for use in high-throughput sample processing.
CFDA approved for clinical use in China and CE marked for IVD use in Europe.
The BRAF V600 mutations detection kit employs a real-time PCR format combined with patented technology - “mutation specific amplification technology” - to detect mutations in DNA samples. The method is much more specific and sensitive than alternative technologies such as DNA sequencing.
Key Features and Benefits:
• Simple Procedure — only one step required for sample application, results could be obtained within 90 minutes；
• High sensitivity and accuracy — can detect1% of mutant in a background of wild type genomic DNA；
• Leading technology — employs AmoyDx’s proprietary technologies-“mutation specific amplification technology”, which is compatible with world-leading technologies;
• Easy Standardization — general PCR lab could perform, technicians could obtain reproducible results without special training, which facilitate standardized management;
• Reliable product quality — Produced in GMP plant, quality management systems has passed Chinese CFDA and ISO13485.
• Sample type: Fresh, frozen or paraffin embedded tissue, blood, serum or plasma