cobas^® 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

CE-IVD

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.

US-IVD

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.

Related systems

cobas^® 4800 System

Highly efficient, flexible workflows and a consolidated assay menu deliver confidence with every result. Automated PCR setup and analysis help make the most of your resources and reduce error.

cobas® KRAS Mutation Test