cobas® EGFR Mutation Test 

 
Registration Status

CE-IVD
Identifies mutations in exons 18, 19, 20 and 21 of the EGFR gene

The cobas® EGFR Mutation Test* offers broad mutation coverage of EGFR exons 18, 19, 20 and 21 to help select non-small cell lung cancer (NSCLC) patients for treatment with EGFR inhibitors.

Features and Benefits
  • The cobas® EGFR Mutation Test detects 41 mutations in Exons 18, 19, 20 and 21 of the EGFR gene.
  • The cobas® EGFR Mutation Test ensures clinicians are provided accurate results to make therapy decisions.†
  • In formalin-fixed, paraffin-embedded tissue (FFPET) specimens, the cobas® EGFR test can detect <5% mutant sequence copies in a background of wild-type DNA.†
  • EGFR test results can typically be obtained from a single 5µm FFPET section with >10% tumor using the cobas® EGFR test.
  • The cobas® EGFR test can be performed in less than 8 hours so results can be reported in a timely manner to the treating physician.
  • Liquid, ready-to-use reagents are provided in the test kit to increase testing efficiency. 
  • Automated result interpretation and test reporting provide consistent, objective and reproducible results from laboratory to laboratory.
Intended Use
 
(CE-IVD, 10/2011, Rev. 1.0)
The cobas® EGFR Mutation Test 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) human non-small cell lung cancer (NSCLC) tumor tissue. The test is intended to be used to identify patients with advanced NSCLC whose tumors harbor mutations in exons 18, 19, 20 and 21 of the EGFR gene, and to select patients for treatment with small-molecule tyrosine kinase inhibitors (TKIs) that target EGFR. Specimens are processed using the cobas® DNA Sample Preparation Kit for manual sample preparation and the cobas z 480 analyzer for automated  amplification and detection.
*Not available in the United States
†cobas® EGFR Mutation Test CE-IVD package insert
More Information
 
For regulatory reasons we are not able to provide further details on our products on this website, but more information may be available from our regional sales representatives.
 
 
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