PIK3CA Five 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 PIK3CA Five Mutations Detection Kit is a sensitive and selective assay for the detection of five mutations in the phosphoinositide-3-kinase catalytic subunit alpha (PIK3CA) gene.
It has been found that PIK3CA gene mutations exist in several types of cancers, including breast cancer and non-small-cell lung cancer. Mutation of PIK3CA may lead to persistent activation of the downstream signaling pathway associated with the development and spread of cancer.
CE marked for IVD use in Europe and CFDA approved for clinical use in China.
The PIK3CA five mutation kit is a real-time PCR assay. It employs mutation-specific primers and a PIK3CA-targeted proprietary fluorescent probe to detect low-copy number (1%) PIK3CA-mutant DNA in cancer tissue.
The kit enables detection of the following mutations against a background of wild-type genomic DNA.
• E542K (1624G>A)
• E545D (1635G>T)
• E545K (1633G>A)
Key Features and Benefits:
• Simple Procedure — only one step required for sample application, results obtained within 90 minutes.
• High sensitivity and accuracy — can detect 1% mutant DNA in a background of wild type genomic DNA.
• 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 SFDA and international ISO13485 standards.
• Sample type: Fresh, frozen, paraffin embedded tissue; blood, plasma.