Identifies mutations in codons 12, 13 and 61 of the KRAS gene
The cobas® KRAS Mutation Test offers broad mutation coverage of KRAS codons 12, 13 and 61 to identify colorectal cancer patients who are not likely to respond to anti-EGFR monoclonal antibody therapies.
Features and Benefits
- The cobas® KRAS Mutation Test detects major mutations in codons 12, 13 and 61 from colorectal cancer patients
- In formalin-fixed, paraffin-embedded tissue (FFPET), the cobas® KRAS Mutation Test can detect <5% mutant sequence copies in a background of wild-type DNA
- Robust, reliable KRAS test results can be obtained from a single, 5µm FFPET section with >10% tumor content using the cobas® KRAS Mutation Test
- The test can be performed in <8 hours so results can be reported to the treating physician within a few days from laboratory receipt of specimen
- Liquid, ready-to-use reagents increase laboratory efficiency
- Automated result interpretation and test reporting provides consistent, objective and reproducible results from laboratory to laboratory
The cobas® KRAS Mutation Test, for use with the cobas® 4800 System, is a real-time PCR test intended for the identification of mutations in codons 12, 13 and 61 of the KRAS gene in DNA derived from formalin-fixed paraffin-embedded human colorectal and non-small cell lung cancer tissues.
The cobas® KRAS Mutation Test, for use with the cobas® 4800 System, is a real-time PCR test for the detection of somatic mutations in codons 12, 13 and 61 of the KRAS gene in DNA derived from formalin-fixed paraffin-embedded human colorectal cancer (CRC) tumor tissue. The test is intended to be used as an aid in the identification of CRC patients who should not be treated with Erbitux® (cetuximab) or with Vectibix® (panitumumab) when KRAS Codon 12 or 13 mutation is detected. Safety and efficacy of Erbitux® (cetuximab) or Vectibix® (panitumumab) have not been established in patients whose tumors have Codon 61 mutation. Specimens are processed using the cobas® DNA Sample Preparation Kit for manual sample preparation and the cobas z 480 analyzer for automated amplification and detection.
The cobas® KRAS Mutation Test detects the following KRAS mutations.
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