Medical Devices

cobas® EGFR Mutation Test – P120019

This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Image of cobas® EGFR Mutation Test

Product Name: cobas® EGFR Mutation Test
PMA Applicant: Roche Molecular Systems, Inc
Address: 4300 Hacienda Drive, Pleasanton, CA 94588, USA
Approval Date: May 14, 2013
Approval Letter: 
http://www.accessdata.fda.gov/cdrh_docs/pdf12/p120019a.pdf

What is it? The cobas® EGFR Mutation Test is an automated molecular assay designed to detect the presence of mutations in the epidermal growth factor receptor (EGFR) gene in non-small cell lung cancer (NSCLC). In normal tissue, the EGFR protein transmits signals in cells to regulate cell growth and cell death. Mutations in the EGFR gene result in abnormal functioning of the EGFR protein and stimulate cancer cell growth in NSCLC.

TARCEVA® (erlotinib) is a drug used to treat patients with NSCLC. TARCEVA® (erlotinib) is an EGFR inhibitor that blocks the abnormal function of the mutant EGFR protein. This test is used to aid physicians in selecting patients with NSCLC for treatment with TARCEVA® (erlotinib). If the test results indicate that EGFR exon 19 deletion or exon 21 (L858R) substitution mutation is present in NSCLC cells, then the patient may be considered for treatment with TARCEVA® (erlotinib).

How does it work?

  • The doctor takes a small amount of tumor tissue from a patient’s NSCLC and examines it (biopsy).
  • The tumor tissue is embedded in a block of paraffin wax. A thin slice of the tumor tissue is cut from the block for use in the test.
  • DNA is isolated from a patient’s tumor cells and mixed with reagents that specifically detect, bind to, and make copies of the tumor’s EGFR gene. This reaction produces fluorescence, which is then measured to determine presence or absence of the specific EGFR mutations in a tumor sample.
  • The presence of specific mutations in the EGFR gene indicates that a patient is eligible for treatment with TARCEVA® (erlotinib).

When is it used? To determine if a patient’s NSCLC characteristics suggest that a patient might be a candidate for TARCEVA® (erlotinib) treatment.

What will it accomplish? The cobas® EGFR Mutation Test helps to determine whether NSCLC patients should be considered for treatment with TARCEVA® (erlotinib), which may prolong their life.

When should it not be used? There are no known contraindications.

Additional information: The Summary of Safety and Effectiveness Data and labeling are available.

Page Last Updated: 08/07/2014
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.