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 |
