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cobas® EGFR Mutation Test v2

Bringing innovation to EGFR molecular testing

Clear results. Confident decisions.

The cobas® EGFR Mutation Test v2 is a real-time PCR test that identifies 42 mutations in exons 18, 19, 20 and 21 of the epidermal growth factor receptor (EGFR) gene, including the T790M resistant mutation.

It is designed to enable testing of both tissue and plasma specimens with a single kit, and allows labs to run tissue and plasma on the same plate simultaneously. For optimised workflow results, Roche has also developed a cell-free DNA (cfDNA) sample preparation kit for extraction of DNA from plasma.

See how the test can help determine which patients to consider for EGFR TKI therapy.

Flexible DNA extraction and sample processing 2 sample types, 1 test

The cobas® EGFR Mutation Test v2 not only provides clinicians with the option of using either tissue or plasma as biopsy samples, but it also makes the processing of these samples more convenient and efficient. Using the test in conjunction with the cobas® 4800 system, laboratory professionals can mix-batch each run with both sample types and even samples from different patients.

The overall workflow is the same regardless of sample type, with slightly different preparation steps. Formalin-fixed, paraffin-embedded tissue (FFPET) specimens are processed using the cobas® DNA Sample Preparation Kit and plasma specimens are processed using the cobas® cfDNA Sample Preparation Kit. After preparation, the amplification and detection of both sample types can be run together—giving labs the flexibility to deliver accurate results using both sample types.

See how both the tissue and plasma-based testing options integrate into existing workflows.

Addressing the obstacles of advanced disease through plasma testing

Patients with advanced NSCLC may not be healthy enough for a tissue biopsy, or might only be able to undergo limited tissue procedures, like a Fine Needle Aspirate (FNA) or Core Needle Biopsy (CNB) for diagnosis.

After first line TKI therapy, it is preferable to use a new tumour specimen for EGFR analysis though this would require another invasive tissue biopsy procedure. The key benefits of testing with plasma is that it involves a non-invasive procedure for collecting biopsy from the patient and it can be sampled as frequently as needed without putting patients at risk.

When testing plasma with the cobas® EGFR Mutation Test v2, a feature called the Semi-Quantitative Index (SQI)* is included in the report—this number is designed to reflect a trend in the EGFR mutation load. If frequently testing a patient for the EGFR mutation, tracking the SQI value and identifying a trend may lead to understanding tumour progression, an option not available in other tests.

*SQI feature is currently not available in the USA.

See how the SQI feature can help track tumour progression and treatment response.


Improving patient care

Many patients with advanced NSCLC are too unhealthy for an invasive tissue biopsy, while others will only be able to undergo limited tissue procedures to have a Fine Needle Aspirate (FNA) or Core Needle Biopsy (CNB) for diagnosis. Additionally, after first line TKI therapy, it’s preferable to use a new tumour specimen for EGFR analysis, yet this would require another invasive tissue biopsy procedure. The key benefits of testing with plasma is that it involves a non-invasive procedure for collecting biopsy from the patient and it can be sampled frequently without putting patients at risk.

See how the new blood-based liquid biopsy offers more options for the most critical patients.

cobas® EGFR Mutation Test by the numbers

EGFR test by numbers

Benefits

  • Provides two options for DNA extraction—from both cfDNA in plasma and from formalin-fixed, paraffin-embedded human NSCLC tissue
  • Detects 42 mutations in exons 18, 19, 20 and 21 of the EGFR gene including the T790M resistant mutation
  • Delivers results in less than 4 hours with plasma and less than 8 hours with tissue samples
  • Increases testing efficiency with liquid-based, ready-to-use reagents
  • Provides consistent, objective and reproducible results from laboratory to laboratory
  • Ensures clinicians are given accurate results to support patient management
Intended use

The cobas® EGFR Mutation Test v2 is a real-time PCR test for the qualitative detection and identification of mutations in exons 18, 19, 20, and 21 of the epidermal growth factor receptor (EGFR) gene in DNA derived from formalin-fixed paraffin-embedded (FFPET) tumor tissue or plasma from non-small cell lung cancer (NSCLC) patients. The test also is intended to be used as an aid in selecting patients with NSCLC for therapy with an EGFR tyrosine kinase inhibitor (TKI).

The cobas® EGFR Mutation Test v2 for use with plasma is further indicated for the semi-quantitative measurement of mutations in exons 18, 19, 20, and 21 of the EGFR gene from serial collections of human plasma as an aid in the management of NSCLC cancer patients.

FFPET specimens are processed using the cobas® DNA Sample Preparation Kit and plasma specimens are processed using the cobas® cfDNA Sample Preparation Kit. The cobas® EGFR Mutation Test v2 and cobas z 480 analyzer are used together for automated amplification and detection.

The cobas® EGFR Mutation Test v2 is a real-time PCR test for the qualitative detection of defined mutations of the epidermal growth factor receptor (EGFR) gene in non-small cell lung cancer (NSCLC) patients. Defined EGFR mutations are detected using DNA isolated from formalin-fixed paraffin-embedded tumor tissue (FFPET) or circulating-free tumor DNA (cFDNA) from plasma derived from EDTA anti-coagulated peripheral whole blood.

The test is indicated as a companion diagnostic to aid in selecting NSCLC patients for treatment with the targeted therapies listed in Table 1 below in accordance with the approved therapeutic product labeling

DrugFFPETPlasma
Test TARCEVA® (erlotinib)Exon 19 deletions and L858RExon 19 deletions and L858R
TAGRISSO™ (osimertinib)T790MTT790M*

Patients with positive cobas® EGFR Mutation Test v2 test results using plasma specimens for the presence of the EGFR mutations listed above are eligible for treatment with the corresponding drug as indicated in Table 1 (see Note* for T790M). Patients who are negative for these mutations by this test should be reflexed to routine biopsy and testing for EGFR mutations with the FFPET sample type.

*The efficacy of TAGRISSO™ (osimertinib) has not been established in EGFR T790M plasma-positive, tissue-negative or unknown population and clinical data for T790M plasma-positive patients are limited; therefore testing using plasma specimens is most appropriate for consideration in patients from whom a tumor biopsy cannot be obtained.

Drug safety and efficacy have not been established for the following EGFR mutations also detected by the cobas® EGFR Mutation Test v2:

DrugFFPETPlasma
TARCEVA® (erlotinib)G719X, exon 20 insertions, T790M, S768I and L861QG719X, exon 20 insertions, T790M, S768I and L861Q
TAGRISSO™ (osimertinib)G719X, exon 19 deletions, L858R, exon 20 insertions, S768I, and L861QG719X, exon 19 deletions, L858R, exon 20 insertions, S768I, and L861Q

For manual sample preparation, FFPET specimens are processed using the cobas® DNA Sample Preparation Kit and plasma specimens are processed using the cobas® cfDNA Sample Preparation Kit. The cobas z 480 analyzer is used for automated amplification and detection.

Enhance your knowledge

For more information on testing for EGFR mutations in plasma and tissue samples from non-small cell lung cancer patients, explore the publications below.