Mutational Analysis of Clinically Significant Mutations in KRAS Tumor Samples
 
- Results from pivotal "408" trial demonstrate panitumumab monotherapy was significantly more effective than best supportive care in treating mCRC patients.
- The treatment effect on progression-free survival (PFS) in the wild-type KRAS group was significantly greater than in the mutant group.
- Response rates to panitumumab were much greater (17% vs. 0%) for the wild-type group. Wild-type KRAS patients also had longer overall survival.
NCCN Guidelines v.4.2008 Recommends KRAS Testing
The panel, therefore, strongly recommends KRAS genotyping of tumor tissue (either primary tumor or metastasis) in all patients with metastatic colorectal cancer.
ASCO 2009 Releases Provisional Clinical Opinion on KRAS Testing
Based on systematic reviews of the relevant literature, all patients with metastatic colorectal carcinoma who are candidates for anti-EGFR antibody therapy should have their tumor tested for KRAS mutations in a CLIA-accredited laboratory.
In wild-type KRAS patients, those carrying a BRAF mutated tumor has shorter progression-free survival (PFS) and overall survival (OS) than wild-type BRAF patients.
Individuals with wild-type BRAF tumors displayed longer PFS and OS than patients with BRAF-mutated tumors.
Of the wild-type patients who responded to therapy, no patients had the BRAF mutation.
PFS and OS were shortened in patients with BRAF mutation than in patients without the mutation.
The Clarient Difference
- Mutation specific real-time PCR used to detect BRAF V600E.
- DNA extraction method specifically developed for optimal assay performance.
- Real-time PCR assay that can detect very low levels of mutations even if contaminated by normal tissue.
- Low failure rate - even on pancreas and lung carcinoma, which are frequently diagnosed on FNA with limited tissue available.
- Rapid turn-around-time 5-7 days (often reported in 5 or less days).
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