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cobas® EGFR Mutation Test v2

The first FDA-approved companion diagnostic test for expanded EGFR tyrosine kinase inhibitors (TKI) therapies in patients with non-small cell lung cancer
RMD_cobas_EGFR_Mutation_Test_v2

Clear results. Confident decisions.

The cobas® EGFR Mutation Test v2 is a real-time polymerase chain reaction (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.1

The cobas® EGFR Mutation Test v2 has been clinically validated in multiple clinical trials as a companion diagnostic (CDx) for both 1st and 2nd line EGFR tyrosine kinase inhibitors (TKI) therapy in patients with advanced non-small cell lung cancer [NSCLC).2 The exceptional robustness and repeatability of the cobas® EGFR Mutation Test v2 has been demonstrated in real-world intra and inter-laboratory studies,3 providing high confidence for labs in using the test.

It is designed to enable fast time-to-results testing of both tissue and plasma specimens simultaneously with a single kit (tissue results < 8 hrs, plasma results < 4 hrs).

For optimized workflow results, Roche has developed the cobas® DNA Sample Preparation Kit for DNA extraction from formalin-fixed paraffin-embedded tissue (FFPET) and the cobas® cfDNA Sample Preparation Kit for extraction of DNA from plasma.

How can the test help determine which patients to consider for EGFR TKI therapy?

Flexible DNA extraction and sample processing

Two sample types. One 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. When using the test in conjunction with the cobas® 4800 System, laboratory professionals can mix-batch each run with both sample types, as well as samples from different patients for up to 28 samples per run.

RMD_G&O_Grafic Simplified Workflow

The overall workflow is similar regardless of sample type. After sample preparation, the amplification and detection of both sample types can be run together - giving labs the flexibility to deliver accurate results using both plasma and tissue samples.

Tissue and plasma-based testing options integrate into existiting 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. A key benefit of testing with plasma is that it involves a non-invasive procedure for collecting a biopsy from the patient, which can be sampled as frequently as needed without putting the patient at risk.

 

The first FDA approved liquid biopsy test for detecting EGFR mutations

 

For blood collection of the liquid biopsy, the cobas® EGFR Mutation Test v2 (CE-IVD) is approved for use with both the Roche Cell-Free DNA Collection Tube (CE-IVD) and K2EDTA tube, offering an alternative method for sample collection. The Roche Cell-Free DNA Collection Tube provides stability of collected blood for up to 7 days at room temperature prior to plasma separation. This increased flexibility in storage and transport of blood prior to plasma separation, facilitates the use of liquid biopsy for NSCLC patients needing molecular testing.

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    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 Reporting Tool not available in the USA

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

    Key Features and Benefits

    • Provides two options for DNA extraction—from plasma and from FFPET
    • Detects 42 mutations in exons 18, 19, 20 and 21 of the EGFR gene including the T790M 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
    • Approved for use with Roche Cell-Free DNA Collection Tube (CE-IVD) and K2EDTA tube for liquid biopsy samples
    • Provides consistent, objective and reproducible results validated by clinical studies
    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 (EGFRJ gene in non-small cell lung cancer (NSCLCJ patients. Defined EGFR mutations are detected using DNA isolated from formalin-fixed paraffin-embedded tumor tissue (FFPET) or circulating tumor DNA (ctDNAJ 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 TAG RISSO® (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

    Package inserts

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

    References

    1. cobas EGFR Mutation Test package insert
    2. Heeke S et al, Clinical Lung Cancer 2019, https://doi.org/10.1016/j.cllc.2019.07.010
    3. Keppens C et al, J Mol Diagnostics 2018, https://doi.org/10.1016/j.jmoldx.2018.03.006
    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
     (erlotinib) Exon 19 deletions and L858R Exon 19 deletions and L858R
     (osimertinib)
    		 Exon 19 deletions, L858R and T790M Exon 19 deletions, L858R and T790M*
     (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
    (erlotinib)

    		 G719X, Exon 20 insertions,
    T790M, S768I and L861Q    		 G719X, exon 20 insertions,
    T790M, S768I and L861Q
    (osimertinib)

    		 G719X, Exon 20 insertions,
    S768I, and L861Q    		 G719X, Exon 20 insertions,
    S768I, and L861Q
    (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.

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