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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 resistance 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.

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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.

RMD_G&O_Grafic Simplified Workflow

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.

A Seamless Workflow

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 a liquid biopsy from the patient and it can be sampled frequently without putting patients at risk.

cobas® EGFR Mutation Test by the numbers

RMD_cobas_EGFR_grafic_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 resistance 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 the targeted therapies listed in Table 1 below in accordance with the approved therapeutic product labeling

 

 Drug  FFPET   Plasma
 TARCEVA® (erlotinib)  Exon 19 deletions and L858R   Exon 19 deletions and L858R
 TAGRISSO™ (osimertinib) 
  T790M  TT790M*

 

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:

 

 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 19 deletions,
 L858R, exon 20 insertions,
 S768I, and L861Q  
  G719X, 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.

Reference

  1. 2015 European Lung Cancer Conference (ELCC): Abstract LBA2_PR. Presented April 17, 2015.
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