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How to collect and prepare samples for testing

 

Tissue Testing

Plasma Testing

Tissue-based testing with the cobas® EGFR Mutation Test v2

  • The cobas® EGFR Mutation Test v2 can detect EGFR T790M mutations using DNA isolated from tissue-based samples1
  • There are various methods used to collect tissue-based samples for EGFR T790M mutation testing
    • A core needle biopsy yields specimens with adequate tumor content for both pathologic subtyping and molecular analysis2
    • A minimum of 2 core needle passes should suffice for adequate sampling3

REMINDER: The EGFR T790M mutation is an acquired mutation that may occur as the tumor adapts to first-line EGFR TKI therapy. It is typically not present during the initial diagnosis; thus, a new biopsy is required to test for EGFR T790M mutations at the time of disease progression.4,5

The cobas® EGFR Mutation Test v2 is indicated as the companion diagnostic to aid in determining NSCLC patient’s eligibility for treatment with TAGRISSO.

INDICATION

TAGRISSO is indicated for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, whose disease has progressed on or after EGFR tyrosine kinase inhibitor therapy.

SELECT SAFETY INFORMATION

  • There are no contraindications for TAGRISSO
  • Interstitial Lung Disease (ILD)/Pneumonitis occurred in 3.5% and was fatal in 0.6% of 833 TAGRISSO-treated patients. Withhold TAGRISSO and promptly investigate for ILD in patients who present with worsening of respiratory symptoms indicative of ILD (eg, dyspnea, cough, and fever). Permanently discontinue TAGRISSO if ILD is confirmed

An example collection workflow for use of tissue-based samples with the cobas® EGFR Mutation Test v26

An example collection workflow for use of tissue-based samples with the cobas® EGFR Mutation Test v2 An example collection workflow for use of tissue-based samples with the cobas® EGFR Mutation Test v2 An example collection workflow for use of tissue-based samples with the cobas® EGFR Mutation Test v2

Obtaining sufficient tumor tissue for histological characterization and molecular testing is important.

Tissue-based samples: requirements for the cobas® EGFR T790M Mutation Test v26

Tissue-based samples: requirements for the cobas® EGFR T790M Mutation Test v2 Tissue-based samples: requirements for the cobas® EGFR T790M Mutation Test v2 Tissue-based samples: requirements for the cobas® EGFR T790M Mutation Test v2

Fixation requirements

Tissue samples are fragile and degradation starts upon removal from the body. Samples should be processed for analysis or fixed immediately to preserve tumor characteristics.7 Formalin and ethanol are both common fixative agents however, formalin fixation is preferred for the use of the cobas® EGFR Mutation Test v2.6

FORMALIN FIXATION8

  • Most common method of fixation
  • Allows for histological and molecular analyses
  • Preferred method of fixation with the cobas® EGFR Mutation Test v2

ETHANOL FIXATION8

  • Often used for cytology
  • Not suitable for most histological analyses
  • May be used for PCR-based EGFR mutation tests
EGFR TKI Resistance Chart EGFR TKI Resistance Chart EGFR TKI Resistance Chart

*Based on the Molecular Testing Guideline for Selection of Lung Cancer Patients for EGFR and ALK Tyrosine Kinase Inhibitors from the College of American Pathologists (CAP), the International Association for the Study of Lung Cancer (IASLC), and the Association for Molecular Pathology (AMP), and endorsed by the American Society of Clinical Oncology (ASCO).8

Reporting EGFR mutation test results

  • When an EGFR T790M mutation test is ordered, the testing laboratory is responsible for communicating the results clearly and effectively to the treating physician
  • The College of American Pathologists (CAP), International Association for the Study of Lung Cancer (IASLC), and Association for Molecular Pathology (AMP) have provided guidelines for the complete reporting of EGFR mutational testing, which include8:

    Results

    • Names of clinically significant mutations identified
    • Histopathologic assessment of tumor content for the tumor tested
    • Reason for assay failure (if needed)

    Interpretation

    • Assessment of tumor’s likelihood to respond to targeted therapy, based on mutation
    • Requirements for repeat testing (if needed)
  • Depending on the laboratory, reporting results for EGFR T790M mutation tests may vary slightly
  • The cobas® test can detect at least a 5% mutation level in the sample and reports the mutation as “detected” or “not detected”7

SAMPLE REPORT

Molecular Pathology Report: cobas® EGFR T790M Mutation Test v2 Molecular Pathology Report: cobas® EGFR T790M Mutation Test v2 Molecular Pathology Report: cobas® EGFR T790M Mutation Test v2
  1. Indicates patient and physician information
  2. Indicates the type of specimen received (eg, tissue) and the type of test being requested (eg T790M mutation test). In the case of a tissue biopsy, the location of the biopsy will also be reported (eg, right lung)
  3. Provides the assesment of the tumor's likelihood to respond to tagrisso based upon T790M mutational status
  4. Indicates which diagnostic assay was used (eg, cobas@ EGFR Mutation Test v2)
  5. Indicates if T790M mutation was detected
  6. Describes any preparation done after receiving the sample and the specific procedure used to test for T790M mutations

Reasons would be given in the case of assay failure, or if repeat testing is needed

  • Based on the results of the EGFR T790M mutation test, it is the physician’s decision how to proceed with a treatment plan8

Contact your pathologist or preferred testing laboratory with any questions you may have about EGFR testing.

Plasma-based testing with the cobas® EGFR Mutation Test v2

  • Plasma testing is effective because DNA from tumor cells, known as circulating tumor DNA (ctDNA), often enters the patient’s bloodstream
  • When blood is collected from the patient, ctDNA from the tumor can be detected1,2

ctDNA-based testing of tumor-specific DNA recommended only for molecular analysis to detect EGFR T790M mutations when tissue biopsy is not feasible1,3

Plasma-based testing with the cobas® EGFR Mutation Test v2 Plasma-based testing with the cobas® EGFR Mutation Test v2 Plasma-based testing with the cobas® EGFR Mutation Test v2

REMINDER: The EGFR T790M mutation is an acquired mutation and may not typically present during the initial diagnosis; thus, a new biopsy is required to test for EGFR mutations at the time of disease progression4,5

Plasma-based samples: steps for using the cobas® EGFR Mutation Test v26

Plasma-based samples: steps for using the cobas® EGFR Mutation Test v2 Plasma-based samples: steps for using the cobas® EGFR Mutation Test v2 Plasma-based samples: steps for using the cobas® EGFR Mutation Test v2

Reporting EGFR mutation test results

  • When an EGFR T790M mutation test is ordered, the testing laboratory is responsible for communicating the results clearly and effectively to the treating physician
  • The College of American Pathologists (CAP), International Association for the Study of Lung Cancer (IASLC), and Association for Molecular Pathology (AMP) have provided guidelines for the complete reporting of EGFR mutational testing, which include7:

    Results

    • Names of clinically significant mutations identified
    • Histopathologic assessment of tumor content for the tumor tested
    • Reason for assay failure (if needed)

    Interpretation

    • Assessment of tumor’s likelihood to respond to targeted therapy, based on mutation
    • Requirements for repeat testing (if needed)
  • Depending on the laboratory, reporting results for EGFR T790M mutation tests may vary slightly
  • The cobas® test can detect at least a 5% mutation level in the sample and reports the mutation as “detected” or “not detected”6

SAMPLE REPORT

Molecular Pathology Report: cobas® EGFR T790M Mutation Test v2 Molecular Pathology Report: cobas® EGFR T790M Mutation Test v2 Molecular Pathology Report: cobas® EGFR T790M Mutation Test v2
  1. Indicates patient and physician information
  2. Indicates the type of specimen received (eg, tissue) and the type of test being requested (eg T790M mutation test). In the case of a tissue biopsy, the location of the biopsy will also be reported(eg, right lung)
  3. Provides the assesment of the tumor's likelihood to respond to tagrisso based upon T790M mutational status
  4. Indicates which diagnostic assay was used (eg, cobas@ EGFR Mutation Test v2)
  5. Indicates if T790M mutation was detected
  6. Describes any preparation done after receiving the sample and the specific procedure used to test for T790M mutations

Reasons would be given in the case of assay failure, or if repeat testing is needed

  • Based on the results of the EGFR T790M mutation test, it is the physician’s decision how to proceed with a treatment plan7

Contact your pathologist or preferred testing laboratory with any questions you may have about EGFR testing.