Overview

The PIK3CA gene plays a central role in regulating cell growth, proliferation, and survival through the PI3K/AKT signaling pathway. Mutations in this gene are among the most frequent oncogenic alterations, driving tumor development and treatment resistance across multiple cancers. Found in approximately 26% of breast cancer, 25% of colorectal cancer, and 2% of lung cancer cases, PIK3CA mutations, especially in exons 9 and 20 are strongly associated with resistance to targeted therapies such as cetuximab (in colorectal cancer) and TKI drugs (in lung cancer). Detecting these mutations with precision is therefore essential for guiding personalized treatment strategies and improving clinical outcomes. To address this critical diagnostic need, Genes2Me offers the PIK3CA-Q Real-Time PCR Kit, a highly sensitive, in vitro diagnostic assay designed for the qualitative detection of five key PIK3CA mutations (E542K, E545K, E545D, H1047R, H1047L) in clinical samples, including fresh tissue and FFPE samples.

The kit leverages mutation-specific TaqMan probes labeled with FAM dye for precise detection, alongside a HEX-labeled quality control probe to ensure assay validity. This dual-probe strategy enables simultaneous mutation detection and process quality control, minimizing false negatives caused by PCR inhibition or poor DNA quality. With six pre-mixed reagents, an enzyme mix, positive control, and RNase/DNase-free water, the workflow is streamlined, user-friendly, and reproducible.