KRAS-Q Real-Time PCR Kit

Product Overview


KRAS mutations are among the most critical biomarkers in oncology, strongly linked with tumour development, resistance to targeted therapies, and poor prognosis. Found in approximately 20–50% of colorectal cancers and 15–30% of lung cancers, mutations in the KRAS gene — especially in codons 12 and 13 of exon 2 — render standard anti-EGFR therapies ineffective, making rapid and accurate KRAS mutation detection essential for guiding personalised treatment strategies. KRAS mutation detection is a standard recommendation in NCCN guidelines for metastatic colorectal cancer, underscoring its importance in identifying patients who may not benefit from EGFR-targeted drugs.

To address this critical clinical need, Genes2Me introduces the KRAS-Q Real-Time PCR Kit — an advanced in vitro diagnostic solution designed for highly sensitive and specific detection of KRAS somatic mutations in DNA extracted from fresh, frozen, or FFPE tissue samples. With a limit of detection as low as 1% mutation frequency, the kit empowers clinicians to make confident, evidence-based treatment decisions.

Targets:
Targets KRAS Somatic Mutations, Exon 2 Codons 12 & 13 (8 variants)
Technology:
Real-Time PCR (Wild-Type Blocking / TaqMan)
Detection:
Qualitative (Detected / Not Detected)
Sample Type:
Fresh Tissue, Frozen Samples, FFPE (DNA)
Certification:
IVD
KRAS-Q Kit

How the Assay Works


The KRAS-Q Kit utilises a wild-type blocking technique combined with allele-specific amplification to selectively detect eight clinically significant KRAS mutations of exon 2, including Gly12Asp, Gly12Val, and Gly13Asp. Detection is achieved via fluorescent TaqMan probes (FAM reporter, BHQ2 quencher), ensuring robust and reliable results. An integrated internal control validates DNA quality, reagent performance, and overall assay integrity in every run, minimising the risk of false-negative results and ensuring dependable performance across challenging sample types including FFPE.

Clinical Relevance


KRAS mutation testing is a cornerstone of precision oncology in colorectal and lung cancer management. Accurate identification of mutation-positive patients enables clinicians to avoid ineffective anti-EGFR therapies and instead select targeted treatment regimens that align with the individual tumour's genetic profile. With 100% analytical sensitivity and specificity, clinical sensitivity and specificity of 99%, and a limit of detection of 1% mutation frequency, the KRAS-Q Kit provides laboratories with dependable molecular diagnostic performance for personalised oncology treatment planning.

Sample Type & Reporting Output


Sample Type:
Fresh Tissue, Frozen Samples, FFPE (DNA)
Reporting Output:
Qualitative detection of KRAS somatic mutations (Detected / Not Detected)
Targets Detected:
KRAS exon 2 mutation sequences (8 variants, codons 12 & 13)

Key Features & Benefits


Comprehensive KRAS Mutation Coverage

Detects eight key KRAS exon 2 mutations at codons 12 and 13, including Gly12Asp, Gly12Val, and Gly13Asp.

High Diagnostic Performance:

100% analytical sensitivity and specificity, clinical sensitivity and specificity of 99%, and precision with CV less than 3%.

Advanced Assay Design

Wild-type blocking combined with allele-specific amplification and TaqMan probe chemistry (FAM reporter, BHQ2 quencher) ensures selective and reliable mutation detection.

Integrated Internal Control

Validates DNA quality, reagent integrity, and assay performance in every run, minimising false-negative 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

Robust detection across fresh tissue, frozen samples, and challenging FFPE specimens for routine clinical use.

Analytical Performance


  • 100% analytical sensitivity and specificity for KRAS exon 2 mutation detection across eight clinically significant variants
  • Clinical sensitivity and specificity of 99%
  • Limit of detection of 1% mutation frequency for sensitive identification of low-frequency KRAS mutations
  • Precision with CV less than 3%, confirming consistent performance across runs and operators
  • Wild-type blocking and allele-specific amplification with TaqMan probes (FAM reporter, BHQ2 quencher) enables selective mutant detection
  • Integrated internal control validates DNA quality and PCR efficiency in every run
  • Robust performance across fresh tissue, frozen, and FFPE-derived DNA
  • 12-month shelf life with stable performance under recommended storage conditions
  • Compatible with QuantStudio™ 5, CFX96, LightCycler® 480, and RapiCycler 96 platforms

With the KRAS-Q Real-Time PCR Kit, laboratories can achieve highly sensitive, reproducible, and clinically meaningful detection of KRAS somatic mutations. By supporting rapid identification of mutation-positive patients, personalised oncology treatment planning, and avoidance of ineffective therapies, the kit helps clinicians make informed decisions for patient care and disease management. Empower your laboratory with the KRAS-Q Real-Time PCR Kit — because timely molecular insights can make a lasting difference in patient outcomes.

Data Analysis and Report


KRAS-Q

When the Ct value of the sample to be tested is outside the reference range and there is a typical S-shaped amplification curve, the test result is positive; When the Ct value of the sample to be tested is within the reference range, or the Ct value is outside the reference range but there is no typical S-shaped amplification curve, the test result is negative.

KRAS-Q

Channel 1 Slope: -3.392 Intercept: 39.372 Correlation: -0.998 Efficiency 3: 97.1430 Channel 3 Slope: -3.240 Intercept: 38.672 Correlation: -0.999 Efficiency 2: 103.52

Ordering Information


Commercial Name Old Cat No. New Cat No. Pack Size
KRAS-Q Real-Time PCR Kit G610052-1 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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