cobas® KRAS Mutation Test

IVD For in vitro diagnostic use.

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

The KRAS Mutation Test detects somatic mutations in codons 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 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.

References

  1. cobas® KRAS Mutation Test Instructions for Use - CE-IVD (06322379001 v11EN); US-IVD (06322352001 v5EN)

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