Cobas Egfr Mutation Test

FDA premarket approval P120019 · Somatic gene mutation detection system

PMA numberP120019

Approval

Applicant
Roche
Received
November 8, 2012
Decision date
May 14, 2013 (APPR)
Supplements
41, latest March 17, 2026
Product code
OWD – Somatic Gene Mutation Detection System

Official FDA PMA record

Approval order statement

APPROVAL FOR THE COBAS® EGFR MUTATION TEST. THE COBAS® EGFR MUTATION TEST IS A REAL-TIME PCR TEST FOR THE QUALITATIVE DETECTION OF EXON 19 DELETIONS AND EXON 21 (L858R) SUBSTITUTION MUTATIONS OFTHE 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 AS AN AID IN SELECTING PATIENTS WITH METASTATIC NSCLC FOR WHOM TARCEVA® (ERLOTINIB), AN EGFR TYROSINE KINASE INHIBITOR (TK1), IS INDICATED. 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.