DiaCarta's QClamp® PIK3CA Codon Specific Mutation Detection kit is a polymerase chain reaction (PCR)-based assay that uses XNA probes to suppress amplification of WT-DNA, selectively amplifying mutant DNAs

The testing procedure involves four (4) simple steps: 1. Isolation of DNA from tumor biopsies, paraffin-embedded sections (FFPE), fresh frozen tumors, or tumor cell lines. 2. Amplification of mutant all DNAs at specified codons within the KRAS gene. 3. Detection of amplification signal using a real-time PCR instrument capable of SYBR green detection 4. Documentation and interpretation of results.

This test can be completed in approximately 2-3 hours from DNA to test result. Limit of Detection <0.1% RUO, <1% CE-IVD. Includes WT and Positive Controls. 4 reactions per sample. Minimal sample input (5-10ng per reaction)

The PIK3CA gene encodes the p110a subunit of phosphatidyl 3-kinase, a lipid kinase involved in cell growth, proliferation, motility and survival. It has a central role in the PI3K-AKT-mTOR pathway. PI3 Kinases are involved in coordinating a diverse range of cell functions including cell growth, proliferation, differentiation, motility, survival and intracellular trafficking. 

PIK3CA mutations are found at 25~40 % frequency in various types of tumors including colorectal cancer, gastric cancer, lung cancer, brain cancer, endometrial cancer, ovarian cancer, breast cancer. About 80 % of the point mutations presides in exon 9 (a presumed helical domain) and exon 20 (a presumed kinase domain), while other types of mutations are also seen in different locations.

The assay identifies the presence of all mutations in and near PIK3CA Codons 542 and 545 (Exon 9) and Codon 1047(Exon 20). All mutations at a particular codon are detected, but the exact nature of the mutation is not specified