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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Devicecobas EGFR MUTATION TEST v2
Classification Namesomatic gene mutation detection system
Generic Namesomatic gene mutation detection system
Applicant
Roche Molecular Systems, Inc.
4300 hacienda drive
pleasanton, CA 94588-2722
PMA NumberP150044
Date Received11/23/2015
Decision Date09/28/2016
APCB Date 05/05/2017
Product Code
OWD[ Registered Establishments with OWD ]
Docket Number 16M-2973
Notice Date 10/10/2016
Advisory Committee Pathology
Expedited Review Granted? Yes
Combination Product No
Approval Order Statement 
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 non-small cell lung cancer (NSCLC) patients. Defined EGFR mutations are detected using DNA isolated from formalin-fixed paraffin-embedded tumor tissue (FFPET) or circulating-free tumor DNA (cfDNA) from plasma derived from EDTA anti-coagulated peripheral whole blood.The test is indicated as a companion diagnostic to aid in selecting NSCLC patients for treatment with the targeted therapies listed in Table 1 below in accordance with the approved therapeutic product labeling:Table 1Drug FFPET PlasmaTARCEVA® (erlotinib) Exon 19 deletions and L858R Exon 19 deletions and L858RTAGRISSO (osimertinib) 790M T790M*Patients with positive cobas® EGFR Mutation Test v2 test results using plasma specimens for the presence of the EGFR mutations listed above are eligible for treatment with the corresponding drug as indicated in Table 1 (see Note* for T790M). Patients who are negative for these mutations by this test should be reflexed to routine biopsy and testing for EGFR mutations with the FFPET sample type. *The efficacy of TAGRISSO (osimertinib) has not been established in the EGFR T790M plasma-positive, tissue-negative or unknown population and clinical data for T790M plasma-positive patients are limited; therefore, testing using plasma specimens is most appropriate for consideration in patients from whom a tumor biopsy cannot be obtained.Drug safety and efficacy have not been established for the EGFR mutations listed in Table 2 below that are also detected by the cobas® EGFR Mutation Test v2: Table 2Drug FFPET PlasmaTARCEVA® (erlotinib) G719X, exon 20 insertions, T790M, S768I and L861Q G719X, exon 20 insertions, T790M, S768I and L861QTAGRISSO (osimertinib) G719X, exon 19 deletions, L858R, exon 20 insertions, S768I, and L861Q G719X, exon 19 deletions, L858R, exon 20 insertions, S768I, and L861QFor manual sample preparation, FFPET specimens are processed using the cobas® DNA Sample Preparation Kit and plasma specimens are processed using the cobas® cfDNA Sample Preparation Kit. The cobas z 480 analyzer is used for automated amplification and detection.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
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