cobas® EGFR Mutation Test v2-RUO

The cobas® EGFR Mutation Test v2, for research use only (RUO), identifies the epidermal growth factor receptor (EGFR) gene in the DNA of non-small cell lung cancer samples derived from plasma. It is the first oncology assay from Roche Molecular Diagnostics to utilize plasma as a sample type.

When using the cobas® EGFR Mutation Test v2 RUO, a new feature called the Semi Quantitative Index, or SQI, is included in the report. 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 understanding of tumor progression, an option not available in other tests.

The cobas® EGFR Mutation Test v2 RUO, is built upon the successful first-generation cobas® EGFR Mutation test (US-IVD & CE-IVD registration), and leverages Roche’s expertise in delivering oncology assays that give clear results for confident decisions.

Features and Benefits

  • The cobas® EGFR Mutation Test v2 RUO identifies 42 mutations in exons 18, 19, 20 and 21 of the EGFR gene using plasma as a sample
  • The cobas® EGFR Mutation Test v2 RUO can be performed in less than 4 hours from isolation to result
  • 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 thecobas® cfDNA Sample Preparation Kit

Amplification and Detection

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

Intended Use

Intended for Research Use Only, not for diagnostic use.