Understanding KRAS and Its Role in Oncology

KRAS is a key oncogene that regulates cellular signaling through the EGFR pathway. Mutations in this gene lead to continuous cell proliferation and are common in several cancers, including colorectal, lung, and thyroid malignancies. Clinical studies show that patients with certain KRAS variants are unlikely to respond to anti-EGFR therapies such as cetuximab or panitumumab. As a result, mutation screening is now a standard part of cancer diagnostics, particularly for metastatic colorectal cancer and non-small cell lung carcinoma.

Clinical Significance of KRAS Mutations

The most clinically relevant mutations occur in codons 12, 13, and 61, with around 40% of colorectal cancers showing at least one of these variants. Detecting these changes helps clinicians tailor treatment strategies, avoid ineffective therapies, and improve patient outcomes. Guidelines from professional bodies like ASCO recommend routine KRAS testing before initiating targeted treatments in eligible patients.

About the TRUPCR® Mutation Kit

This IVD-certified kit is designed to identify somatic mutations in the KRAS gene using a highly sensitive PCR-based method. It includes 11 mutation-specific assays and a reference gene region free from known polymorphisms. Fluorescent probes (FAM and HEX) ensure clear signal detection, and the kit workflow is compatible with commonly used qPCR systems.

The inclusion of an extraction control enhances reliability by flagging poor-quality or failed extractions, helping reduce false-negative results. The kit’s design ensures coverage of the most important mutations for therapy decision-making.

How the Technology Works

The core technology is ARMS-PCR, which uses allele-specific primers to distinguish between wild-type and mutant DNA. Taq polymerase’s ability to differentiate between matched and mismatched primer ends allows selective amplification of mutation-specific sequences, even in heterogeneous samples.

Workflow highlights:

1. Extract DNA from clinical tissue (FFPE, fresh, or frozen)
2. Prepare PCR reactions using provided primers and probes
3. Run the assay on a compatible real-time PCR instrument
4. Interpret results via fluorescence detection and mutation-specific signals

Applications in Clinical Diagnostics

This assay supports oncologists and pathologists in identifying KRAS mutations quickly and accurately. Its application is particularly valuable in:

• Metastatic colorectal cancer (mCRC)
• Lung adenocarcinoma
• Thyroid carcinoma

By integrating this kit into routine testing, labs can deliver clinically actionable results that support personalized medicine and improve therapy outcomes.