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.

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.

 

 Codon Mutation ID 
 AA Change
COSMIC ID
 12   c.34G>T
   12C
  516
 12   c.34G>A
   12S   517
 12   c.34G>C
   12R
  518
 12   c.35G>T
   12V
  520
 12   c.35G>A
   12D
  521
 12   c.35G>C
   12A
  522
 13   c.38G>A
   13D
  532
 61   c.181C>A
   61K
  549
 61   c.181C>G
   61E
  550
 61   c.182A>C
   61P
  551
 61   c.182A>G
   61R
  552
 61    c.182A>T
   61L
  553
 61   c.183A>C
   61Hc
  554
 61   c.183A>T
   61Ht
  555

Registration status

CE-IVD, US-IVD

Package inserts

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