cobas® EGFR Mutation Test v2 (US-IVD)

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 isintended to be used as an aid in identifying patients with NSCLC for therapy with the EGFR tyrosine kinase inhibitors (TKI) Tarceva® or TAGRISSO™. The test utilizes tissue samples that have been formalin-fixed and paraffin embedded.

With clear, actionable results, the cobas® EGFR Mutation Test v2 gives clinicians the information needed to make confident treatment decisions.

Features and Benefits

  • The cobas® EGFR Mutation Test v2 identifies 42 mutations in exons 18, 19, 20 and 21 of the  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

Sample Preparation
Sample preparation for the cobas® EGFR Mutation Test v2 is manual.

Amplification and Detection
Following sample preparation, Roche recommends the cobas z 480 analyzer for automated amplification and detection.

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 from non-small cell lung cancer 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

For manual sample preparation, FFPET specimens are processed using the cobas® DNA Sample Preparation Kit and the cobas z 480 analyzer is used for automated amplification and detection.