cobas® KRAS Mutation Test

KRAS Mutation Test

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
Intended use

Intended use

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.

Registration status

CE-IVD, US-IVD

Package inserts

Access package inserts through your country’s Roche Diagnostics Website.