cobas® EGFR Mutation Test v2 (CE-IVD)

The cobas® EGFR Mutation Test v2 CE-IVD, identifies the epidermal growth factor receptor (EGFR) gene in the DNA from non-small cell lung cancer (NSCLC) patients and is intended to be used as an aid in selecting patients with NSCLC for therapy with an EGFR tyrosine kinase inhibitor (TKI).

This innovative assay from Roche Molecular Diagnostics is the first to utilize plasma in addition to tissue as a sample type, thus removing common barriers to molecular testing, including surgery risks and sample availability. With clear, actionable results, the cobas® EGFR Mutation Test v2 CE-IVD gives clinicians the information needed to make confident treatment decisions.

The cobas® EGFR Mutation Test v2 CE-IVD comes with a new feature in the report called the Semi Quantitative Index, or SQI. This number is designed to represent the percent of mutation in the sample tested. If frequently testing for the EGFR mutation using the test, tracking the SQI value and identifying a trend may lead to the understanding of tumor progression, an option not available in other tests.

Features and Benefits

The cobas® EGFR Mutation Test v2 CE-IVD identifies 42 mutations in exons 18, 19, 20 and 21 of the EGFR gene using tissue or plasma as a sample

  • The cobas® EGFR Mutation Test v2 CE-IVD can be performed in less than 4 hours from isolation to result
  • Plasma-based testing provides a less invasive testing option that may overcome the limitations of formalin-fixed, paraffin-embedded tissue sample
  • Reports feature an SQI, providing information about the percent mutation in the sample tested
  • Automated result interpretation and test reporting provide consistent, objective and reproducible results from laboratory to laboratory

Features and Benefits

  • The cobas® EGFR Mutation Test v2 CE-IVD identifies 42 mutations in exons 18, 19, 20 and 21 of the EGFR gene using tissue or plasma as a sample
  • The cobas® EGFR Mutation Test v2 CE-IVD can be performed in less than 4 hours from isolation to result
  • Plasma-based testing provides a less invasive testing option that may overcome the limitations of formalin-fixed, paraffin-embedded tissue sample
  • Reports feature an SQI, providing information about the percent mutation in the sample tested
  • 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.

  • For plasma testing, Roche recommends the cobas® cfDNA Sample Preparation Kit
  • For tissue testing, Roche recommends the cobas® DNA Sample Preparation Kit

Amplification and Detection

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

Intended Use

The cobas® EGFR Mutation Test v2 is a real-time PCR test for the qualitative detection and identification of mutations in exons 18, 19, 20, and 21 of the epidermal growth factor receptor (EGFR) gene in DNA derived from formalin-fixed paraffin-embedded (FFPET) tumor tissue or plasma from non-small cell lung cancer (NSCLC) patients. The test also is intended to be used as an aid in selecting patients with NSCLC for therapy with an EGFR tyrosine kinase inhibitor (TKI).

The cobas® EGFR Mutation Test v2 for use with plasma is further indicated for the semi-quantitative measurement of mutations in exons 18, 19, 20, and 21 of the EGFR gene from serial collections of human plasma as an aid in the management of NSCLC cancer patients.

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® EGFR Mutation Test v2 and cobas z 480 analyzer are used together for automated amplification and detection.