FDA approves first blood test to detect gene mutation associated with non-small cell lung cancer.

June 1, 2016

UntitledThe U.S. Food and Drug Administration today approved the cobas EGFR Mutation Test v2, a blood-based companion diagnostic for the cancer drug Tarceva (erlotinib).

This is the first FDA-approved, blood-based genetic test that can detect epidermal growth factor receptor (EGFR) gene mutations in non-small cell lung cancer patients.

Such mutations are present in approximately 10-20 percent of non-small cell lung cancers (NSCLC).

The cobas EGFR Mutation Test v2 (US-IVD), identifies mutations in the epidermal growth factor receptor (EGFR) gene in tumor tissue DNA from non-small cell lung cancer (NSCLC) patients and is intended to be used as an aid in identifying patients with NSCLC for therapy with the EGFR tyrosine kinase inhibitors (TKI) Tarceva or TAGRISSO.

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Source- Roche (http://molecular.roche.com/diseases/Pages/EGFR_liquid_biopsy.aspx)

Features and Benefits

  • The cobas EGFR Mutation Test v2 identifies 42 mutations in exons 18, 19, 20 and 21 of the EGFR gene using tissue as a sample
  • The cobas EGFR Mutation Test v2 US-IVD can be performed in less than 8 hours from isolation to result
  • Automated result interpretation and test reporting provide consistent, objective and reproducible results from laboratory to laboratory
  • 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 DNA derived from formalin-fixed paraffin-embedded tumor tissue (FFPET) from non-small cell lung cancer (NSCLC) patients. The test is intended to aid in identifying patients with NSCLC whose tumors have defined EGFR mutations and for whom safety and efficacy of a drug have been established as follows:

    • Tarceva (erlotinib) – Exon 19 deletions and L858R

    • Tagrisso (osimertinib) – T790M

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

    • Tarceva (erlotinib) – G719X, exon 20 insertions, T790M, S768I and L861Q
    • Tagrisso (osimertinib) – G719X,
      exon 19 deletions, L858R, exon 20 insertions, S768I, and L861Q.

    With the cobas EGFR Mutation Test v2, the presence of specific NSCLC mutations [exon 19 deletion or exon 21 (L858R) substitution mutations] detected in patients’ blood samples aids in selecting those who may benefit from treatment with Tarceva. However, if such mutations are not detected in the blood, then a tumor biopsy should be performed to determine if the NSCLC mutations are present. Insofar as the test provides positive results, it may benefit patients who may be too ill or are otherwise unable to provide a tumor specimen for EGFR testing.

    The efficacy of the cobas EGFR Mutation Test v2 using blood samples was determined by using the test to identify the EGFR mutation status in patients enrolled into a clinical trial whose tumor biopsies were previously confirmed positive for the EGFR exon 19 deletion or L858R mutations as determined by the cobas EGFR Mutation Test v1.

    The FDA approved Tarceva in 2004 to treat patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen, and in 2013, the FDA approved it for  the first-line treatment of patients with metastatic non-small cell lung cancer whose tumors having EGFR exon 19 deletions or L858R substitution mutations as detected by an FDA-approved test. The most common side effects of Tarceva are rash, diarrhea, anorexia, fatigue, difficulty breathing (dyspnea), cough, nausea and vomiting. Tarceva is not recommended for use in combination with platinum-based chemotherapy and the drug has not been evaluated as first-line treatment in patients with metastatic NSCLC whose tumors have EGFR mutations other than exon 19 deletions or L858R substitution mutations.

    The cobas EGFR Mutation Test v2 is manufactured by Roche Molecular Systems in
    Pleasanton, California. Tarceva is manufactured by Astellas Pharma Technologies, Inc. of Norman, Oklahoma and distributed by Genentech Inc., of South San Francisco, California.


  • http://molecular.roche.com/assays/Pages/cobasEGFRMutationTest.aspx
  • http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm504488.htm