Molecular Diagnostic Assays

KRAS MUTATION ANALYSIS

Test Code: 220
Methodology: Real-Time PCR
Turnaround Time: 10 business days

Detection of KRAS mutations in a background of wild-type genomic DNA in a real-time PCR assay based on Amplification Refractory Mutation System (ARMS) and real-time polymerase chain reaction, using DxS Scorpions Technology. The test can detect the presence or absence of seven common mutations (Gly12Ala, Gly12Asp, Gly12Arg, Gly12Cys, Gly12Ser, Gly12Val, Gly13Asp) found in codons 12 and 13 of the KRAS oncogene against a background of wild-type DNA. The tumor tissue must be greater than 50 percent tumor cells for accurate test results. KRAS mutation status is critical when evaluating a patient for EGFR-targeted therapy since KRAS mutations are strongly predictive of lack of response to anti-EGFR therapy in colorectal cancer and non-small cell lung cancer.

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BRAF MUTATION ANALYSIS

Test Code: 221
Methodology: Real-Time PCR
Turnaround Time: 10 business days

Detection of the V660E mutation in the BRAF oncogene against a background of wild-type genomic DNA using a real-time polymerase chainreaction (PCR) assay based on Amplification Refractory Mutation System (ARMS) and DxS Scorpions Technology. The assay can detect 1 percent of mutant in a background of wild-type genomic DNA. BRAF mutation analysis requires formalin-fixed paraffin-embedded (FFPE) tumor tissue containing > 50 percent tumor for optimal results. BRAF mutation status is important for identifying candidates for EGFR-targeted therapies in colorectal cancer since BRAF V600E mutations have been shown to be predictive of lack of response to anti-EGFR therapy.

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