EGFR-Q Real-Time PCR Kit

Product Overview

Lung cancer remains the leading cause of cancer-related deaths worldwide, with non-small cell lung cancer (NSCLC) accounting for 80% of cases. Among NSCLC patients, mutations in the epidermal growth factor receptor (EGFR) gene play a pivotal role in tumour progression, angiogenesis, and resistance to apoptosis. Clinical studies have consistently shown that the effectiveness of EGFR tyrosine kinase inhibitors (TKIs) is directly linked to EGFR mutation status, making accurate and timely molecular profiling a cornerstone of precision oncology.

To meet this critical need, Genes2Me introduces the EGFR-Q Real-Time PCR Kit — an advanced in vitro diagnostic solution designed for the qualitative detection of EGFR somatic mutations in genomic DNA extracted from clinical samples, including fresh tissue and formalin-fixed paraffin-embedded (FFPE) tissue. By identifying mutations in exons 18 to 21 of the EGFR gene, including 19del (45% prevalence) and L858R (40 to 45% prevalence), the kit empowers clinicians to select the right therapy and improve patient outcomes.

Targets:
EGFR Somatic Mutations: L858R, T790M, G719X, 19del, L861Q, 3Ins20, S768I
Technology:
Real-Time PCR (TaqMan)
Detection:
Qualitative
Sample Type:
Fresh Tissue, FFPE Tissue (Genomic DNA)
Certification:
IVD
EGFR-Q

How the Assay Works

The EGFR-Q Kit uses an optimised real-time PCR workflow for the detection of EGFR somatic mutations in genomic DNA. Mutation-specific TaqMan probes enable precise identification of each target variant. A built-in internal control monitors sample quality, reagent integrity, and overall workflow performance in every run, minimising the risk of false-negative results and ensuring assay reliability. Designed for use by trained laboratory professionals, the kit delivers precise results within hours to support timely treatment decisions

Clinical Relevance

EGFR mutation testing is central to the management of NSCLC. Detection of actionable mutations directly informs the selection of targeted therapies. The EGFR-Q Kit covers seven clinically relevant mutations across exons 18 to 21, providing a comprehensive mutation profile that guides prescribing decisions for EGFR-TKIs such as gefitinib, erlotinib, and osimertinib. With high sensitivity capable of detecting mutations at 0.25 to 0.5% allele frequency, the kit ensures reliable results even from challenging FFPE samples, bridging cutting-edge molecular testing with real-world clinical needs in the fight against lung cancer.

Sample Type & Reporting Output

Sample Type:
Fresh Tissue, FFPE Tissue (Genomic DNA)
Reporting Output:
Qualitative detection of EGFR somatic mutations
Targets Detected:
L858R, T790M, G719X, 19del, L861Q, 3Ins20, S768I

Key Features & Benefits

Comprehensive Mutation Coverage

Detects seven clinically actionable EGFR mutations — L858R, T790M, G719X, 19del, L861Q, 3Ins20, and S768I — providing a complete mutation profile for guiding targeted therapy decisions.

High Sensitivity and Specificity

Detects mutations at 0.25 to 0.5% allele frequency, ensuring reliable results even from challenging FFPE samples.

Built-In Internal Control

Monitors sample quality, reagents, and workflow performance in every run to minimise false-negative results and ensure assay reliability.

Robust Contamination Control

Incorporates UDG enzyme technology to prevent carryover contamination and maintain result integrity.

Flexible Compatibility

Validated on leading real-time PCR platforms including Thermo Fisher QuantStudio 5, Bio-Rad CFX96, Roche LightCycler 480, and Genes2Me RapiCycler 96.

Fast and Streamlined Workflow

Optimised real-time PCR protocol with ready-to-use reagents delivers precise results within hours, supporting timely treatment decisions.

Analytical Performance

  • High sensitivity and specificity for detection of all seven EGFR somatic mutation targets: L858R, T790M, G719X, 19del, L861Q, 3Ins20, and S768I
  • Optimised real-time PCR workflow for efficient and accurate mutation detection from genomic DNA
  • Built-in internal control monitors sample quality, reagent integrity, and workflow performance in every run
  • Detection at 0.25 to 0.5% allele frequency ensures reliable results even from low-input or FFPE-derived samples
  • UDG enzyme technology incorporated for robust contamination control
  • Compatible with QuantStudio 5, CFX96, LightCycler 480, and RapiCycler 96 platforms

With the EGFR-Q Real-Time PCR Kit, laboratories can achieve highly sensitive, reproducible, and clinically meaningful detection of EGFR somatic mutations in NSCLC. By supporting comprehensive mutation profiling across seven actionable targets, the kit helps clinicians make informed, evidence-based decisions for targeted therapy selection. Empower your laboratory with the EGFR-Q Real-Time PCR Kit — because timely molecular insights can make a lasting difference in patient outcomes.

Data Analysis and Report

EGFR-Q

EGFR-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
EGFR-Q Real-Time PCR Kit G2M708721 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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