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cobas® KRAS Mutation Test

KRAS Mutation Test

A real-time PCR test for the detection and identification of KRAS mutations

The cobas® KRAS Mutation Test detects 19 somatic mutations in codons 12, 13, and 61 of the kirsten rat sarcoma viral oncogene homolog (KRAS) gene in DNA derived from formalin-fixed paraffin-embedded (FFPE) colorectal cancer (CRC) tissues.

Each test comes with liquid, ready-to-use reagents for increased laboratory efficiency. Tests can be performed in <8 hours, allowing results to be reported to the treating physician within a few days from laboratory receipt of specimen.

Specimens are processed using the cobas® DNA Sample Preparation Kit1 to extract DNA from FFPE tissue. Mutation detection is achieved through polymerase chain reaction (PCR) analysis with the cobas z 480 Analyzer for automated amplification and detection.

Features and benefits2

  • Detects ≥ 5% mutant sequence copies in a background of wild-type DNA
  • Robust, reliable test results can be obtained from a single, 5µm FFPET section with >10% tumor content
  • Consistent, objective, and reproducible results in <8 hours
  • Automated result interpretation and test reporting
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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

References

  1. Lambert, A et al, Pathology & Oncology Research (2019) 25:1117–1123
  2. cobas PIK3CA Mutation Test package insert
  3. cobas DNA Sample Preparation Kit package insert
Product image for cobas® DNA Sample Preparation Kit
cobas® DNA Sample Preparation Kit
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cobas® 4800 System