PMA P120019S007

Device

COBAS EGFR MUTATION TEST V2

Applicant

Roche

PMA number

P120019

Supplement

S007

Product code

OWD

Decision date

2015-11-13

Classification

Somatic Gene Mutation Detection System

Generic name

Somatic gene mutation detection system

Approval order statement

APPROVAL FOR THE COBAS® EGFR MUTATION TEST V2. THIS DEVICE IS INDICATED FOR:THE COBAS® EGFR MUTATION TEST V2 IS A REAL-TIME PCR TEST FOR THE QUALITATIVE DETECTION OF DEFINED MUTATIONS OF THE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) GENE IN DNA DERIVED FROM FORMALIN-FIXED PARAFFIN-EMBEDDED TUMOR TISSUE (FFPET) FROM NON-SMALL CELL LUNG CANCER (NSCLC) PATIENTS. THE TEST IS INTENDED TO AID IN IDENTIFYING PATIENTS WITH NSCLC WHOSE TUMORS HAVE DEFINED EGFR MUTATIONS AND FOR WHOM SAFETY AND EFFICACY OF A DRUG HAVE BEEN ESTABLISHED AS FOLLOWS: TARCEVA® (ERLOTINIB)/EXON 19 DELETIONS AND L858R AND TAGRISSO® (OSIMERTINIB) T790M. DRUG SAFETY AND EFFICACY HAVE NOT BEEN ESTABLISHED FOR THE FOLLOWING EGFR MUTATIONS ALSO DETECTED BY THE COBAS® EGFR MUTATION TEST V2: TARCEVA® (ERLOTINIB)/G719X, EXON 20 INSERTIONS, T790M, S768I AND L861Q/TAGRISSO® (OSIMERTINIB)/G719X, EXON 19 DELETIONS, L858R, EXON 20 INSERTIONS, S768I, AND L861Q. FOR MANUAL SAMPLE PREPARATION, FFPET SPECIMENS ARE PROCESSED USING THE COBAS® DNA SAMPLE PREPARATION KIT AND THE COBAS Z 480 ANALYZER IS USED FOR AUTOMATED AMPLIFICATION AND DETECTION.

Summary

<a href="http://www.accessdata.fda.gov/cdrh_docs/pdf12/P120019S007B.pdf" target="_new">Summary of Safety and Effectiveness</a>