PIK3CA-Q Real-Time PCR Kit

Product Overview

The PIK3CA gene plays a central role in regulating cell growth, proliferation, and survival through the PI3K/AKT signalling pathway. Mutations in this gene are among the most frequent oncogenic alterations, driving tumour development and treatment resistance across multiple cancers. Found in approximately 26% of breast cancers, 25% of colorectal cancers, and 2% of lung cancers, 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 personalised treatment strategies and improving clinical outcomes.

To address this critical diagnostic need, Genes2Me introduces 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, and H1047L) in clinical samples, including fresh tissue and FFPE samples.

Targets:
PIK3CA Mutations: E542K, E545K, E545D (Exon 9); H1047R, H1047L (Exon 20)
Technology:
Real-Time PCR (TaqMan)
Detection:
Qualitative (Detected / Not Detected)
Sample Type:
Fresh Tissue, FFPE (DNA)
Certification:
IVD
PIK3CA-Q Real-Time PCR Kit

How the Assay Works

The PIK3CA-Q Kit leverages mutation-specific TaqMan probes labeled with FAM dye for precise detection of the five target PIK3CA mutations, alongside a HEX-labeled quality control probe to ensure assay validity. This dual-probe strategy enables simultaneous mutation detection and process quality control, minimising false-negative results 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 across routine and advanced oncology diagnostic settings.

Clinical Relevance

PIK3CA mutation testing supports clinicians and laboratories across multiple cancer types. In colorectal cancer, detection of PIK3CA mutations identifies alterations that predict resistance to anti-EGFR therapy. In breast cancer, the kit detects mutations with direct implications in hormone receptor-positive tumours. In lung cancer, PIK3CA mutation profiling guides treatment decisions where PI3K-driven resistance affects TKI response. By targeting the most prevalent PIK3CA mutations across exons 9 and 20, the kit provides laboratories with dependable molecular diagnostic performance to support precision oncology and personalised treatment planning.

Sample Type & Reporting Output

Sample Type:
Fresh Tissue, FFPE (DNA)
Reporting Output:
Qualitative detection of PIK3CA mutations (Detected / Not Detected)
Targets Detected:
PIK3CA mutation sequences: E542K, E545K, E545D (Exon 9); H1047R, H1047L (Exon 20)

Key Features & Benefits

Comprehensive PIK3CA Mutation Coverage

Detects five major PIK3CA mutations across exons 9 and 20: E542K, E545K, and E545D (exon 9); H1047R and H1047L (exon 20).

High Sensitivity & Specificity

Mutation-specific FAM-labeled TaqMan probes ensure robust and reliable detection of low-frequency PIK3CA variants in clinical samples.

Dual-Probe Assay Design

Integrated HEX-labeled quality control probe monitors DNA quality and PCR performance in every run, minimising false-negative results.

Streamlined Ready-to-Use Workflow

Six pre-mixed reagents, enzyme mix, positive control, and RNase/DNase-free water simplify setup, reduce handling errors, and ensure reproducible results.

Flexible Compatibility

Validated on leading Real-Time PCR platforms including Thermo Fisher QuantStudio™ 5, Bio-Rad CFX96, Roche LightCycler® 480, and Genes2Me RapiCycler 96.

Versatile Sample Compatibility

Validated for use with fresh tissue and FFPE-derived DNA, suitable for routine clinical diagnostics and advanced molecular oncology applications.

Applications

  • Colorectal Cancer: Identifies PIK3CA mutations associated with resistance to anti-EGFR therapies, helping avoid ineffective treatment.
  • Breast Cancer: Detects clinically relevant alterations with direct therapeutic implications in hormone receptor–positive tumors.
  • Lung Cancer: Supports treatment selection in cases where PIK3CA-driven resistance impacts response to TKI therapies.
  • Long Shelf Life: Stable under recommended storage conditions, ensuring consistent performance across laboratories.

Analytical Performance

  • High sensitivity and specificity for detection of five key PIK3CA mutations: E542K, E545K, E545D (exon 9) and H1047R, H1047L (exon 20)
  • Mutation-specific FAM-labeled TaqMan probes enable robust detection of low-frequency variants in clinical samples
  • HEX-labeled quality control probe monitors DNA quality and PCR inhibition in every run
  • Six pre-mixed reagents with enzyme mix, positive control, and RNase/DNase-free water ensure a reproducible and streamlined workflow
  • Validated for use with both fresh tissue and FFPE-derived DNA across colorectal, breast, and lung cancer applications
  • Compatible with QuantStudio™ 5, CFX96, LightCycler® 480, and RapiCycler 96 platforms

With the PIK3CA-Q Real-Time PCR Kit, laboratories can achieve highly sensitive, reproducible, and clinically meaningful detection of PIK3CA somatic mutations. By supporting accurate mutation identification, targeted therapy selection, and improved clinical evaluation across breast, colorectal, and lung cancers, the kit helps clinicians make informed decisions for patient care and disease management. Empower your laboratory with the PIK3CA-Q Real-Time PCR Kit — because timely molecular insights can make a lasting difference in patient outcomes.

Data Analysis and Report

PIK3CA-Q Real-Time PCR_Amplification

PIK3CA-Q Real-Time PCR specific amplification plot of Treponema pallidum Positive Control (HEX Channel) along with Internal Control (Cy5 Channel)

Ordering Information

Commercial Name Old Cat No. New Cat No. Pack Size
PIK3CA-Q Real-Time PCR Kit G2M708221 G610019-1 50 Tests

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Since its inception in 2016, Genes2me has been constantly striving towards setting a benchmark in the diagnostics space by introducing premium quality (Made in India) diagnostic kits which are CE-IVD, ISO-13485:2016, and ISO 9001:2015 certified, assuring our clients of unparalleled quality and compliance with international standards.

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