PIK3CA Five Mutations Detection Kit

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Amoy Diagnostics Co.,Ltd.

Business Type:Manufacturer


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Product Information

  • Certification:CE
  • Warranty:1 year


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. 

Intended Use: 
CE marked for IVD use in Europe and CFDA approved for clinical use in China.

Technological Principles: 
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.

• H1047R(3140A>G)
• H1047L(3140A>T)
• 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.

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