cobas® EGFR Mutation Test v2

RMD_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 optimized workflow results, Roche has developed a cell-free DNA (cfDNA) sample preparation kit to optimize extraction of DNA from plasma.

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.

RMD_G&O_Grafic Simplified Workflow
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 tumor progression, an option not available in other tests.

*SQI feature is currently not available in the USA.

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 tumor 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.

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

Intended use

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 EGFR tyrosine kinase inhibitors (including the targeted therapies listed in Table 1 below) in accordance with the approved therapeutic product labeling:

Table 1

 Drug  FFPET   Plasma
 TARCEVA® (erlotinib)  Exon 19 deletions and L858R   Exon 19 deletions and L858R
 TAGRISSO® (osimertinib) 
 Exon 19 deletions, L858R and T790M  Exon 19 deletions, L858R and T790M*
  IRESSA® (gefitinib)
 Exon 19 deletions and L858R  Exon 19 deletions and L858R

 

Testing of plasma specimens is most appropriate for consideration in patients from whom a tumor biopsy cannot be obtained. Patients who are negative for these mutations by this test using plasma specimens should be reflexed to routine tissue biopsy and testing for EGFR mutations with the FFPET sample type, if available.

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

Table 2

 Drug  FFPET   Plasma
 TARCEVA®  (erlotinib)

 G719X, Exon 20 insertions, 
 T790M, S768I and L861Q
 G719X, exon 20 insertions,
 T790M, S768I and L861Q
 TAGRISSO® (osimertinib)
 
 G719X, Exon 20 insertions, 
 S768I, and L861Q
 G719X, Exon 20 insertions,
 S768I, and L861Q  
 IRESSA® (gefitinib)
 
 G719X, Exon 20 insertions, 
 T790M, S768I and L861Q
 G719X, exon 20 insertions,
 T790M, S768I and L861Q

 

The cobas® EGFR Mutation Test v2 for use with plasma includes a semi-quantitative measurement of mutations in exons 18, 19, 20, and 21 of the EGFR gene. This measurement, reported as a semi-quantitative index (SQI), correlates to the amount of target mutant cfDNA in plasma and can be used to determine changes in target mutant cfDNA load over time for a given patient.

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.

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 tumor DNA (ctDNA) 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: 

Table 1

 Drug  FFPET   Plasma
 TARCEVA® (erlotinib)  Exon 19 deletions and L858R   Exon 19 deletions and L858R
 TAGRISSO™ (osimertinib) 
 Exon 19 deletions, L858R and T790M  Exon 19 deletions, L858R and T790M*
  IRESSA® (gefitinib)
 Exon 19 deletions and L858R  Exon 19 deletions and L858R

 

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 using plasma specimens should be reflexed to routine biopsy and testing for EGFR mutations with the FFPET sample type.

Note: *The efficacy of TAGRISSO® (osimertinib) has not been established in the 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:

Table 2

 Drug  FFPET   Plasma
 TARCEVA®  (erlotinib)

 G719X, Exon 20 insertions,
 T790M, S768I and L861Q
 G719X, exon 20 insertions,
 T790M, S768I and L861Q
 TAGRISSO® (osimertinib)
 
 G719X, Exon 20 insertions,
 S768I, and L861Q
 G719X, Exon 20 insertions,
 S768I, and L861Q  
 IRESSA® (gefitinib)
 
 G719X, Exon 20 insertions,
 T790M, S768I and L861Q
 G719X, exon 20 insertions,
 T790M, 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.

Registration status

CE-IVD, US-IVD, RUO

Package inserts

Access package inserts through your country’s Roche Diagnostics Website.

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